立项配置页初步优化

.gitignore

@@ -43,7 +43,7 @@ pyrightconfig.json
 
 # Node/Vite frontend
 frontend/node_modules/
-frontend/dist/
+#frontend/dist/
 frontend/.vite/
 npm-debug.log*
 yarn-debug.log*

backend/alembic/versions/20260206_01_add_ae_sae_susar_flags.py

@@ -0,0 +1,36 @@
+"""add is_sae and is_susar flags to adverse events
+
+Revision ID: 20260206_01
+Revises: 20260116_08
+Create Date: 2026-02-06 10:20:00.000000
+
+"""
+from typing import Sequence, Union
+
+from alembic import op
+import sqlalchemy as sa
+
+
+# revision identifiers, used by Alembic.
+revision: str = "20260206_01"
+down_revision: Union[str, None] = "20260116_08"
+branch_labels: Union[str, Sequence[str], None] = None
+depends_on: Union[str, Sequence[str], None] = None
+
+
+def upgrade() -> None:
+    op.add_column(
+        "adverse_events",
+        sa.Column("is_sae", sa.Boolean(), nullable=False, server_default=sa.false()),
+    )
+    op.add_column(
+        "adverse_events",
+        sa.Column("is_susar", sa.Boolean(), nullable=False, server_default=sa.false()),
+    )
+    op.alter_column("adverse_events", "is_sae", server_default=None)
+    op.alter_column("adverse_events", "is_susar", server_default=None)
+
+
+def downgrade() -> None:
+    op.drop_column("adverse_events", "is_susar")
+    op.drop_column("adverse_events", "is_sae")

backend/alembic/versions/20260206_02_add_study_setup_configs.py

@@ -0,0 +1,56 @@
+"""add study_setup_configs table
+
+Revision ID: 20260206_02
+Revises: 20260206_01
+Create Date: 2026-02-06 19:10:00.000000
+
+"""
+from typing import Sequence, Union
+
+from alembic import op
+import sqlalchemy as sa
+from sqlalchemy.dialects import postgresql
+
+
+# revision identifiers, used by Alembic.
+revision: str = "20260206_02"
+down_revision: Union[str, None] = "20260206_01"
+branch_labels: Union[str, Sequence[str], None] = None
+depends_on: Union[str, Sequence[str], None] = None
+
+
+def upgrade() -> None:
+    bind = op.get_bind()
+    inspector = sa.inspect(bind)
+
+    if "study_setup_configs" not in inspector.get_table_names():
+        op.create_table(
+            "study_setup_configs",
+            sa.Column("id", postgresql.UUID(as_uuid=True), nullable=False),
+            sa.Column("study_id", postgresql.UUID(as_uuid=True), nullable=False),
+            sa.Column("version", sa.Integer(), nullable=False, server_default="1"),
+            sa.Column("config", postgresql.JSONB(astext_type=sa.Text()), nullable=False),
+            sa.Column("saved_by", postgresql.UUID(as_uuid=True), nullable=True),
+            sa.Column("created_at", sa.DateTime(timezone=True), server_default=sa.text("now()"), nullable=False),
+            sa.Column("updated_at", sa.DateTime(timezone=True), server_default=sa.text("now()"), nullable=False),
+            sa.ForeignKeyConstraint(["saved_by"], ["users.id"]),
+            sa.ForeignKeyConstraint(["study_id"], ["studies.id"]),
+            sa.PrimaryKeyConstraint("id"),
+            sa.UniqueConstraint("study_id", name="uq_study_setup_config_study"),
+        )
+
+    indexes = {idx["name"] for idx in inspector.get_indexes("study_setup_configs")}
+    index_name = op.f("ix_study_setup_configs_study_id")
+    if index_name not in indexes:
+        op.create_index(index_name, "study_setup_configs", ["study_id"], unique=False)
+
+    uniques = {uq["name"] for uq in inspector.get_unique_constraints("study_setup_configs") if uq.get("name")}
+    if "uq_study_setup_config_study" not in uniques:
+        op.create_unique_constraint("uq_study_setup_config_study", "study_setup_configs", ["study_id"])
+
+    op.execute("ALTER TABLE study_setup_configs ALTER COLUMN version DROP DEFAULT")
+
+
+def downgrade() -> None:
+    op.drop_index(op.f("ix_study_setup_configs_study_id"), table_name="study_setup_configs")
+    op.drop_table("study_setup_configs")

backend/alembic/versions/20260206_03_add_setup_config_publish_fields.py

@@ -0,0 +1,66 @@
+"""add setup config publish fields
+
+Revision ID: 20260206_03
+Revises: 20260206_02
+Create Date: 2026-02-06 19:40:00.000000
+
+"""
+from typing import Sequence, Union
+
+from alembic import op
+import sqlalchemy as sa
+from sqlalchemy.dialects import postgresql
+
+
+# revision identifiers, used by Alembic.
+revision: str = "20260206_03"
+down_revision: Union[str, None] = "20260206_02"
+branch_labels: Union[str, Sequence[str], None] = None
+depends_on: Union[str, Sequence[str], None] = None
+
+
+def upgrade() -> None:
+    bind = op.get_bind()
+    inspector = sa.inspect(bind)
+    columns = {c["name"] for c in inspector.get_columns("study_setup_configs")}
+
+    if "publish_status" not in columns:
+        op.add_column(
+            "study_setup_configs",
+            sa.Column("publish_status", sa.String(length=20), nullable=False, server_default="DRAFT"),
+        )
+        op.alter_column("study_setup_configs", "publish_status", server_default=None)
+
+    if "published_config" not in columns:
+        op.add_column(
+            "study_setup_configs",
+            sa.Column("published_config", postgresql.JSONB(astext_type=sa.Text()), nullable=True),
+        )
+
+    if "published_by" not in columns:
+        op.add_column(
+            "study_setup_configs",
+            sa.Column("published_by", postgresql.UUID(as_uuid=True), nullable=True),
+        )
+        op.create_foreign_key(
+            "study_setup_configs_published_by_fkey",
+            "study_setup_configs",
+            "users",
+            ["published_by"],
+            ["id"],
+        )
+
+    if "published_at" not in columns:
+        op.add_column(
+            "study_setup_configs",
+            sa.Column("published_at", sa.DateTime(timezone=True), nullable=True),
+        )
+
+
+def downgrade() -> None:
+    op.drop_column("study_setup_configs", "published_at")
+    op.drop_constraint("study_setup_configs_published_by_fkey", "study_setup_configs", type_="foreignkey")
+    op.drop_column("study_setup_configs", "published_by")
+    op.drop_column("study_setup_configs", "published_config")
+    op.drop_column("study_setup_configs", "publish_status")
+

backend/alembic/versions/20260211_01_add_study_setup_config_versions.py

@@ -0,0 +1,75 @@
+"""add study setup config versions table
+
+Revision ID: 20260211_01
+Revises: 20260206_03
+Create Date: 2026-02-11 11:30:00.000000
+
+"""
+from typing import Sequence, Union
+
+from alembic import op
+import sqlalchemy as sa
+from sqlalchemy.dialects import postgresql
+
+
+# revision identifiers, used by Alembic.
+revision: str = "20260211_01"
+down_revision: Union[str, None] = "20260206_03"
+branch_labels: Union[str, Sequence[str], None] = None
+depends_on: Union[str, Sequence[str], None] = None
+
+
+def upgrade() -> None:
+    bind = op.get_bind()
+    inspector = sa.inspect(bind)
+    tables = set(inspector.get_table_names())
+
+    if "study_setup_config_versions" not in tables:
+        op.create_table(
+            "study_setup_config_versions",
+            sa.Column("id", postgresql.UUID(as_uuid=True), nullable=False),
+            sa.Column("study_setup_config_id", postgresql.UUID(as_uuid=True), nullable=False),
+            sa.Column("study_id", postgresql.UUID(as_uuid=True), nullable=False),
+            sa.Column("version", sa.Integer(), nullable=False),
+            sa.Column("source_version", sa.Integer(), nullable=True),
+            sa.Column("config", postgresql.JSONB(astext_type=sa.Text()), nullable=False),
+            sa.Column("published_by", postgresql.UUID(as_uuid=True), nullable=True),
+            sa.Column("published_at", sa.DateTime(timezone=True), nullable=False, server_default=sa.text("now()")),
+            sa.Column("created_at", sa.DateTime(timezone=True), nullable=False, server_default=sa.text("now()")),
+            sa.ForeignKeyConstraint(["published_by"], ["users.id"]),
+            sa.ForeignKeyConstraint(["study_id"], ["studies.id"]),
+            sa.ForeignKeyConstraint(["study_setup_config_id"], ["study_setup_configs.id"]),
+            sa.PrimaryKeyConstraint("id"),
+            sa.UniqueConstraint("study_id", "version", name="uq_setup_config_versions_study_version"),
+        )
+
+    existing_indexes = {idx["name"] for idx in inspector.get_indexes("study_setup_config_versions")}
+    if "ix_study_setup_config_versions_study_setup_config_id" not in existing_indexes:
+        op.create_index(
+            "ix_study_setup_config_versions_study_setup_config_id",
+            "study_setup_config_versions",
+            ["study_setup_config_id"],
+            unique=False,
+        )
+    if "ix_study_setup_config_versions_study_id" not in existing_indexes:
+        op.create_index(
+            "ix_study_setup_config_versions_study_id",
+            "study_setup_config_versions",
+            ["study_id"],
+            unique=False,
+        )
+
+
+def downgrade() -> None:
+    bind = op.get_bind()
+    inspector = sa.inspect(bind)
+    tables = set(inspector.get_table_names())
+    if "study_setup_config_versions" not in tables:
+        return
+
+    indexes = {idx["name"] for idx in inspector.get_indexes("study_setup_config_versions")}
+    if "ix_study_setup_config_versions_study_setup_config_id" in indexes:
+        op.drop_index("ix_study_setup_config_versions_study_setup_config_id", table_name="study_setup_config_versions")
+    if "ix_study_setup_config_versions_study_id" in indexes:
+        op.drop_index("ix_study_setup_config_versions_study_id", table_name="study_setup_config_versions")
+    op.drop_table("study_setup_config_versions")

backend/alembic/versions/20260211_02_add_study_extended_profile_fields.py

@@ -0,0 +1,88 @@
+"""add extended profile fields to studies
+
+Revision ID: 20260211_02
+Revises: 20260211_01
+Create Date: 2026-02-11 14:20:00.000000
+
+"""
+from typing import Sequence, Union
+
+from alembic import op
+import sqlalchemy as sa
+
+
+# revision identifiers, used by Alembic.
+revision: str = "20260211_02"
+down_revision: Union[str, None] = "20260211_01"
+branch_labels: Union[str, Sequence[str], None] = None
+depends_on: Union[str, Sequence[str], None] = None
+
+
+def upgrade() -> None:
+    bind = op.get_bind()
+    inspector = sa.inspect(bind)
+    columns = {col["name"] for col in inspector.get_columns("studies")}
+
+    if "project_full_name" not in columns:
+        op.add_column("studies", sa.Column("project_full_name", sa.String(length=500), nullable=True))
+    if "lead_unit" not in columns:
+        op.add_column("studies", sa.Column("lead_unit", sa.String(length=255), nullable=True))
+    if "principal_investigator" not in columns:
+        op.add_column("studies", sa.Column("principal_investigator", sa.String(length=255), nullable=True))
+    if "main_pm" not in columns:
+        op.add_column("studies", sa.Column("main_pm", sa.String(length=255), nullable=True))
+    if "research_analysis" not in columns:
+        op.add_column("studies", sa.Column("research_analysis", sa.Text(), nullable=True))
+    if "research_product" not in columns:
+        op.add_column("studies", sa.Column("research_product", sa.String(length=255), nullable=True))
+    if "control_product" not in columns:
+        op.add_column("studies", sa.Column("control_product", sa.String(length=255), nullable=True))
+    if "indication" not in columns:
+        op.add_column("studies", sa.Column("indication", sa.String(length=255), nullable=True))
+    if "research_population" not in columns:
+        op.add_column("studies", sa.Column("research_population", sa.String(length=255), nullable=True))
+    if "research_design" not in columns:
+        op.add_column("studies", sa.Column("research_design", sa.Text(), nullable=True))
+    if "plan_start_date" not in columns:
+        op.add_column("studies", sa.Column("plan_start_date", sa.Date(), nullable=True))
+    if "plan_end_date" not in columns:
+        op.add_column("studies", sa.Column("plan_end_date", sa.Date(), nullable=True))
+    if "planned_site_count" not in columns:
+        op.add_column("studies", sa.Column("planned_site_count", sa.Integer(), nullable=True))
+    if "planned_enrollment_count" not in columns:
+        op.add_column("studies", sa.Column("planned_enrollment_count", sa.Integer(), nullable=True))
+
+
+def downgrade() -> None:
+    bind = op.get_bind()
+    inspector = sa.inspect(bind)
+    columns = {col["name"] for col in inspector.get_columns("studies")}
+
+    if "planned_enrollment_count" in columns:
+        op.drop_column("studies", "planned_enrollment_count")
+    if "planned_site_count" in columns:
+        op.drop_column("studies", "planned_site_count")
+    if "plan_end_date" in columns:
+        op.drop_column("studies", "plan_end_date")
+    if "plan_start_date" in columns:
+        op.drop_column("studies", "plan_start_date")
+    if "research_design" in columns:
+        op.drop_column("studies", "research_design")
+    if "research_population" in columns:
+        op.drop_column("studies", "research_population")
+    if "indication" in columns:
+        op.drop_column("studies", "indication")
+    if "control_product" in columns:
+        op.drop_column("studies", "control_product")
+    if "research_product" in columns:
+        op.drop_column("studies", "research_product")
+    if "research_analysis" in columns:
+        op.drop_column("studies", "research_analysis")
+    if "main_pm" in columns:
+        op.drop_column("studies", "main_pm")
+    if "principal_investigator" in columns:
+        op.drop_column("studies", "principal_investigator")
+    if "lead_unit" in columns:
+        op.drop_column("studies", "lead_unit")
+    if "project_full_name" in columns:
+        op.drop_column("studies", "project_full_name")

backend/alembic/versions/20260213_01_add_display_version_to_setup_config_versions.py

@@ -0,0 +1,77 @@
+"""add display version to setup config versions
+
+Revision ID: 20260213_01
+Revises: 20260211_02
+Create Date: 2026-02-13 12:10:00.000000
+
+"""
+from typing import Sequence, Union
+
+from alembic import op
+import sqlalchemy as sa
+
+
+# revision identifiers, used by Alembic.
+revision: str = "20260213_01"
+down_revision: Union[str, None] = "20260211_02"
+branch_labels: Union[str, Sequence[str], None] = None
+depends_on: Union[str, Sequence[str], None] = None
+
+
+def upgrade() -> None:
+    bind = op.get_bind()
+    inspector = sa.inspect(bind)
+    columns = {col["name"] for col in inspector.get_columns("study_setup_config_versions")}
+
+    if "display_version" not in columns:
+        op.add_column(
+            "study_setup_config_versions",
+            sa.Column("display_version", sa.Integer(), nullable=True),
+        )
+
+    op.execute(
+        sa.text(
+            """
+            WITH ranked AS (
+                SELECT
+                    id,
+                    ROW_NUMBER() OVER (
+                        PARTITION BY study_id
+                        ORDER BY published_at ASC, version ASC
+                    ) AS rn
+                FROM study_setup_config_versions
+            )
+            UPDATE study_setup_config_versions v
+            SET display_version = ranked.rn
+            FROM ranked
+            WHERE v.id = ranked.id
+              AND v.display_version IS NULL
+            """
+        )
+    )
+
+    op.alter_column("study_setup_config_versions", "display_version", nullable=False)
+
+    uniques = {item["name"] for item in inspector.get_unique_constraints("study_setup_config_versions")}
+    if "uq_setup_config_versions_study_display_version" not in uniques:
+        op.create_unique_constraint(
+            "uq_setup_config_versions_study_display_version",
+            "study_setup_config_versions",
+            ["study_id", "display_version"],
+        )
+
+
+def downgrade() -> None:
+    bind = op.get_bind()
+    inspector = sa.inspect(bind)
+    uniques = {item["name"] for item in inspector.get_unique_constraints("study_setup_config_versions")}
+    if "uq_setup_config_versions_study_display_version" in uniques:
+        op.drop_constraint(
+            "uq_setup_config_versions_study_display_version",
+            "study_setup_config_versions",
+            type_="unique",
+        )
+
+    columns = {col["name"] for col in inspector.get_columns("study_setup_config_versions")}
+    if "display_version" in columns:
+        op.drop_column("study_setup_config_versions", "display_version")

backend/alembic/versions/20260213_02_add_setup_projection_fields.py

@@ -0,0 +1,64 @@
+"""add setup projection fields to studies and sites
+
+Revision ID: 20260213_02
+Revises: 20260213_01
+Create Date: 2026-02-13 16:30:00.000000
+
+"""
+from typing import Sequence, Union
+
+from alembic import op
+import sqlalchemy as sa
+
+
+# revision identifiers, used by Alembic.
+revision: str = "20260213_02"
+down_revision: Union[str, None] = "20260213_01"
+branch_labels: Union[str, Sequence[str], None] = None
+depends_on: Union[str, Sequence[str], None] = None
+
+
+def upgrade() -> None:
+    bind = op.get_bind()
+    inspector = sa.inspect(bind)
+
+    study_columns = {col["name"] for col in inspector.get_columns("studies")}
+    if "enrollment_monthly_goal_note" not in study_columns:
+        op.add_column("studies", sa.Column("enrollment_monthly_goal_note", sa.Text(), nullable=True))
+    if "enrollment_stage_breakdown" not in study_columns:
+        op.add_column("studies", sa.Column("enrollment_stage_breakdown", sa.Text(), nullable=True))
+    if "summary_note" not in study_columns:
+        op.add_column("studies", sa.Column("summary_note", sa.Text(), nullable=True))
+    if "objective_note" not in study_columns:
+        op.add_column("studies", sa.Column("objective_note", sa.Text(), nullable=True))
+
+    site_columns = {col["name"] for col in inspector.get_columns("sites")}
+    if "enrollment_plan_start_date" not in site_columns:
+        op.add_column("sites", sa.Column("enrollment_plan_start_date", sa.Date(), nullable=True))
+    if "enrollment_plan_end_date" not in site_columns:
+        op.add_column("sites", sa.Column("enrollment_plan_end_date", sa.Date(), nullable=True))
+    if "enrollment_plan_note" not in site_columns:
+        op.add_column("sites", sa.Column("enrollment_plan_note", sa.Text(), nullable=True))
+
+
+def downgrade() -> None:
+    bind = op.get_bind()
+    inspector = sa.inspect(bind)
+
+    site_columns = {col["name"] for col in inspector.get_columns("sites")}
+    if "enrollment_plan_note" in site_columns:
+        op.drop_column("sites", "enrollment_plan_note")
+    if "enrollment_plan_end_date" in site_columns:
+        op.drop_column("sites", "enrollment_plan_end_date")
+    if "enrollment_plan_start_date" in site_columns:
+        op.drop_column("sites", "enrollment_plan_start_date")
+
+    study_columns = {col["name"] for col in inspector.get_columns("studies")}
+    if "objective_note" in study_columns:
+        op.drop_column("studies", "objective_note")
+    if "summary_note" in study_columns:
+        op.drop_column("studies", "summary_note")
+    if "enrollment_stage_breakdown" in study_columns:
+        op.drop_column("studies", "enrollment_stage_breakdown")
+    if "enrollment_monthly_goal_note" in study_columns:
+        op.drop_column("studies", "enrollment_monthly_goal_note")

backend/alembic/versions/20260213_03_add_setup_projection_entities.py

@@ -0,0 +1,88 @@
+"""add setup projection entities for monitoring and center confirm
+
+Revision ID: 20260213_03
+Revises: 20260213_02
+Create Date: 2026-02-13 11:20:00.000000
+
+"""
+from typing import Sequence, Union
+
+from alembic import op
+import sqlalchemy as sa
+from sqlalchemy.dialects import postgresql
+
+
+# revision identifiers, used by Alembic.
+revision: str = "20260213_03"
+down_revision: Union[str, None] = "20260213_02"
+branch_labels: Union[str, Sequence[str], None] = None
+depends_on: Union[str, Sequence[str], None] = None
+
+
+def upgrade() -> None:
+    bind = op.get_bind()
+    inspector = sa.inspect(bind)
+
+    milestone_columns = {col["name"] for col in inspector.get_columns("milestones")}
+    if "owner_name" not in milestone_columns:
+        op.add_column("milestones", sa.Column("owner_name", sa.String(length=255), nullable=True))
+
+    if "study_monitoring_strategies" not in inspector.get_table_names():
+        op.create_table(
+            "study_monitoring_strategies",
+            sa.Column("id", postgresql.UUID(as_uuid=True), nullable=False),
+            sa.Column("study_id", postgresql.UUID(as_uuid=True), nullable=False),
+            sa.Column("source_setup_item_id", sa.String(length=64), nullable=True),
+            sa.Column("strategy_type", sa.String(length=50), nullable=False),
+            sa.Column("detail", sa.Text(), nullable=False),
+            sa.Column("frequency", sa.String(length=50), nullable=False),
+            sa.Column("enabled", sa.Boolean(), nullable=False, server_default=sa.text("true")),
+            sa.Column("created_at", sa.DateTime(timezone=True), nullable=False, server_default=sa.text("now()")),
+            sa.Column("updated_at", sa.DateTime(timezone=True), nullable=False, server_default=sa.text("now()")),
+            sa.ForeignKeyConstraint(["study_id"], ["studies.id"]),
+            sa.PrimaryKeyConstraint("id"),
+        )
+        op.create_index(
+            "ix_study_monitoring_strategies_study_id",
+            "study_monitoring_strategies",
+            ["study_id"],
+            unique=False,
+        )
+
+    if "study_center_confirms" not in inspector.get_table_names():
+        op.create_table(
+            "study_center_confirms",
+            sa.Column("id", postgresql.UUID(as_uuid=True), nullable=False),
+            sa.Column("study_id", postgresql.UUID(as_uuid=True), nullable=False),
+            sa.Column("site_id", postgresql.UUID(as_uuid=True), nullable=False),
+            sa.Column("source_setup_item_id", sa.String(length=64), nullable=True),
+            sa.Column("confirmer", sa.String(length=255), nullable=True),
+            sa.Column("confirm_status", sa.String(length=20), nullable=False),
+            sa.Column("confirm_date", sa.Date(), nullable=True),
+            sa.Column("note", sa.Text(), nullable=True),
+            sa.Column("created_at", sa.DateTime(timezone=True), nullable=False, server_default=sa.text("now()")),
+            sa.Column("updated_at", sa.DateTime(timezone=True), nullable=False, server_default=sa.text("now()")),
+            sa.ForeignKeyConstraint(["site_id"], ["sites.id"]),
+            sa.ForeignKeyConstraint(["study_id"], ["studies.id"]),
+            sa.PrimaryKeyConstraint("id"),
+        )
+        op.create_index("ix_study_center_confirms_site_id", "study_center_confirms", ["site_id"], unique=False)
+        op.create_index("ix_study_center_confirms_study_id", "study_center_confirms", ["study_id"], unique=False)
+
+
+def downgrade() -> None:
+    bind = op.get_bind()
+    inspector = sa.inspect(bind)
+
+    if "study_center_confirms" in inspector.get_table_names():
+        op.drop_index("ix_study_center_confirms_study_id", table_name="study_center_confirms")
+        op.drop_index("ix_study_center_confirms_site_id", table_name="study_center_confirms")
+        op.drop_table("study_center_confirms")
+
+    if "study_monitoring_strategies" in inspector.get_table_names():
+        op.drop_index("ix_study_monitoring_strategies_study_id", table_name="study_monitoring_strategies")
+        op.drop_table("study_monitoring_strategies")
+
+    milestone_columns = {col["name"] for col in inspector.get_columns("milestones")}
+    if "owner_name" in milestone_columns:
+        op.drop_column("milestones", "owner_name")

backend/app/api/v1/studies.py

@@ -1,19 +1,340 @@
 import uuid
+import re
+from io import BytesIO
+from datetime import date
+from collections import Counter
 
-from fastapi import APIRouter, Depends, HTTPException, status
+from fastapi import APIRouter, Depends, File, Form, HTTPException, UploadFile, status
+from fastapi.responses import StreamingResponse
 from sqlalchemy.ext.asyncio import AsyncSession
 
-from app.core.deps import get_current_user, get_db_session, require_roles, require_study_member, require_study_roles
+from app.core.deps import (
+    get_current_user,
+    get_db_session,
+    require_roles,
+    require_study_member,
+    require_study_not_locked,
+    require_study_roles,
+)
 from app.crud import study as study_crud
 from app.crud import member as member_crud
 from app.crud import audit as audit_crud
+from app.crud import site as site_crud
+from app.crud import study_setup_config as study_setup_config_crud
+from app.crud import user as user_crud
+from app.services.setup_config_excel import export_setup_config_excel, import_setup_config_excel
 from app.schemas.common import PaginatedResponse
 from app.schemas.study import StudyCreate, StudyRead, StudyUpdate
 from app.schemas.member import StudyMemberCreate
+from app.schemas.study_setup_config import (
+    SetupProjectionSummary,
+    StudySetupConfigData,
+    StudySetupConfigPublish,
+    StudySetupConfigRead,
+    StudySetupConfigRollback,
+    StudySetupConfigUpsert,
+    StudySetupConfigVersionRead,
+)
+from app.services.setup_config_projection import apply_setup_projection_on_publish
 from app.utils.pagination import paginate
 
 router = APIRouter()
 
+def _raise_validation_error(errors: list[dict[str, str]]) -> None:
+    raise HTTPException(
+        status_code=status.HTTP_422_UNPROCESSABLE_ENTITY,
+        detail={
+            "code": "VALIDATION_ERROR",
+            "message": "校验失败",
+            "errors": errors,
+        },
+    )
+
+
+def _raise_conflict_error() -> None:
+    raise HTTPException(
+        status_code=status.HTTP_409_CONFLICT,
+        detail={
+            "code": "SETUP_CONFIG_VERSION_CONFLICT",
+            "message": "配置版本冲突，请刷新后重试",
+        },
+    )
+
+
+def _parse_date_str(value: str, field: str, errors: list[dict[str, str]]) -> date | None:
+    if not value:
+        return None
+    try:
+        return date.fromisoformat(value)
+    except ValueError:
+        errors.append({"field": field, "message": "日期格式应为 YYYY-MM-DD"})
+        return None
+
+
+def _is_empty_row(values: list[str | None]) -> bool:
+    return all(not (item or "").strip() for item in values)
+
+
+def _validate_setup_data(
+    payload: StudySetupConfigData,
+    study_sites: dict[str, str],
+    *,
+    project_plan_start: date | None = None,
+    project_plan_end: date | None = None,
+) -> None:
+    errors: list[dict[str, str]] = []
+    allowed_milestone_status = {"未开始", "进行中", "已完成", "延期"}
+    allowed_strategy_types = {
+        "启动访视",
+        "筛选访视",
+        "监查访视",
+        "协同访视",
+        "风险访视",
+        "末次访视",
+    }
+    allowed_confirm_status = {"待确认", "已确认", "退回"}
+
+    for index, row in enumerate(payload.projectMilestones):
+        row_prefix = f"projectMilestones[{index}]"
+        if not row.id:
+            errors.append({"field": f"{row_prefix}.id", "message": "ID不能为空"})
+        if _is_empty_row([row.name, row.owner, row.remark, row.planDate]):
+            continue
+        if not row.name.strip():
+            errors.append({"field": f"{row_prefix}.name", "message": "里程碑名称不能为空"})
+        _parse_date_str(row.planDate, f"{row_prefix}.planDate", errors)
+        if row.status not in allowed_milestone_status:
+            errors.append({"field": f"{row_prefix}.status", "message": "里程碑状态不合法"})
+
+    plan = payload.enrollmentPlan
+    if plan.totalTarget < 0:
+        errors.append({"field": "enrollmentPlan.totalTarget", "message": "计划总入组例数不能小于0"})
+    enrollment_plan_start = _parse_date_str(plan.startDate, "enrollmentPlan.startDate", errors)
+    enrollment_plan_end = _parse_date_str(plan.endDate, "enrollmentPlan.endDate", errors)
+    if not plan.startDate:
+        errors.append({"field": "enrollmentPlan.startDate", "message": "请填写计划开始日期"})
+    if not plan.endDate:
+        errors.append({"field": "enrollmentPlan.endDate", "message": "请填写计划结束日期"})
+    if enrollment_plan_start and enrollment_plan_end and enrollment_plan_start > enrollment_plan_end:
+        errors.append({"field": "enrollmentPlan.endDate", "message": "结束日期不能早于开始日期"})
+    if project_plan_start and enrollment_plan_start and enrollment_plan_start < project_plan_start:
+        errors.append({"field": "enrollmentPlan.startDate", "message": "项目入组计划开始日期不能早于项目计划开始日期"})
+    if project_plan_end and enrollment_plan_start and enrollment_plan_start > project_plan_end:
+        errors.append({"field": "enrollmentPlan.startDate", "message": "项目入组计划开始日期不能晚于项目计划结束日期"})
+    if project_plan_start and enrollment_plan_end and enrollment_plan_end < project_plan_start:
+        errors.append({"field": "enrollmentPlan.endDate", "message": "项目入组计划结束日期不能早于项目计划开始日期"})
+    if project_plan_end and enrollment_plan_end and enrollment_plan_end > project_plan_end:
+        errors.append({"field": "enrollmentPlan.endDate", "message": "项目入组计划结束日期不能晚于项目计划结束日期"})
+
+    total_site_target = 0
+    for index, row in enumerate(payload.siteMilestones):
+        row_prefix = f"siteMilestones[{index}]"
+        if not row.id:
+            errors.append({"field": f"{row_prefix}.id", "message": "ID不能为空"})
+        if _is_empty_row([row.milestone, row.owner, row.remark, row.planDate]):
+            continue
+        if not row.milestone.strip():
+            errors.append({"field": f"{row_prefix}.milestone", "message": "中心里程碑不能为空"})
+        if row.status not in allowed_milestone_status:
+            errors.append({"field": f"{row_prefix}.status", "message": "里程碑状态不合法"})
+        plan_date = _parse_date_str(row.planDate, f"{row_prefix}.planDate", errors)
+        if project_plan_start and plan_date and plan_date < project_plan_start:
+            errors.append({"field": f"{row_prefix}.planDate", "message": "中心里程碑日期不能早于项目计划开始日期"})
+        if project_plan_end and plan_date and plan_date > project_plan_end:
+            errors.append({"field": f"{row_prefix}.planDate", "message": "中心里程碑日期不能晚于项目计划结束日期"})
+
+    seen_site_enrollment_site_ids: set[str] = set()
+    for index, row in enumerate(payload.siteEnrollmentPlans):
+        row_prefix = f"siteEnrollmentPlans[{index}]"
+        if not row.id:
+            errors.append({"field": f"{row_prefix}.id", "message": "ID不能为空"})
+        if _is_empty_row([row.siteId, row.note, row.startDate, row.endDate]):
+            continue
+        site_id = (row.siteId or "").strip()
+        if not site_id:
+            errors.append({"field": f"{row_prefix}.siteId", "message": "请选择中心"})
+        elif site_id not in study_sites:
+            errors.append({"field": f"{row_prefix}.siteId", "message": "中心不属于当前项目"})
+        elif site_id in seen_site_enrollment_site_ids:
+            errors.append({"field": f"{row_prefix}.siteId", "message": "中心入组计划不允许重复配置同一中心"})
+        else:
+            seen_site_enrollment_site_ids.add(site_id)
+        if row.target < 0:
+            errors.append({"field": f"{row_prefix}.target", "message": "目标入组人数不能小于0"})
+        total_site_target += max(row.target, 0)
+        start = _parse_date_str(row.startDate, f"{row_prefix}.startDate", errors)
+        end = _parse_date_str(row.endDate, f"{row_prefix}.endDate", errors)
+        if not row.startDate:
+            errors.append({"field": f"{row_prefix}.startDate", "message": "请填写启动日期"})
+        if not row.endDate:
+            errors.append({"field": f"{row_prefix}.endDate", "message": "请填写完成日期"})
+        if start and end and start > end:
+            errors.append({"field": f"{row_prefix}.endDate", "message": "完成日期不能早于启动日期"})
+        if project_plan_start and start and start < project_plan_start:
+            errors.append({"field": f"{row_prefix}.startDate", "message": "中心启动日期不能早于项目计划开始日期"})
+        if project_plan_end and start and start > project_plan_end:
+            errors.append({"field": f"{row_prefix}.startDate", "message": "中心启动日期不能晚于项目计划结束日期"})
+        if project_plan_start and end and end < project_plan_start:
+            errors.append({"field": f"{row_prefix}.endDate", "message": "中心完成日期不能早于项目计划开始日期"})
+        if project_plan_end and end and end > project_plan_end:
+            errors.append({"field": f"{row_prefix}.endDate", "message": "中心完成日期不能晚于项目计划结束日期"})
+
+    if total_site_target > plan.totalTarget:
+        errors.append({"field": "siteEnrollmentPlans", "message": "中心计划总例数不能超过项目总入组例数"})
+
+    for index, row in enumerate(payload.monitoringStrategies):
+        row_prefix = f"monitoringStrategies[{index}]"
+        if not row.id:
+            errors.append({"field": f"{row_prefix}.id", "message": "ID不能为空"})
+        if _is_empty_row([row.strategyType, row.detail, row.frequency]):
+            continue
+        if row.strategyType not in allowed_strategy_types:
+            errors.append({"field": f"{row_prefix}.strategyType", "message": "监查类型不合法"})
+        if not row.detail.strip():
+            errors.append({"field": f"{row_prefix}.detail", "message": "策略详情不能为空"})
+        if row.frequency not in {"不限", "按触发", "每月1次"} and re.fullmatch(r"\d+次", row.frequency) is None:
+            errors.append({"field": f"{row_prefix}.frequency", "message": "监查次数格式应为“不限”/“按触发”/“每月1次”或“N次”"})
+
+    for index, row in enumerate(payload.centerConfirm):
+        row_prefix = f"centerConfirm[{index}]"
+        if not row.id:
+            errors.append({"field": f"{row_prefix}.id", "message": "ID不能为空"})
+        if _is_empty_row([row.siteId, row.confirmer, row.note, row.confirmDate]):
+            continue
+        if not row.siteId:
+            errors.append({"field": f"{row_prefix}.siteId", "message": "请选择中心"})
+        elif row.siteId not in study_sites:
+            errors.append({"field": f"{row_prefix}.siteId", "message": "中心不属于当前项目"})
+        if row.confirmStatus not in allowed_confirm_status:
+            errors.append({"field": f"{row_prefix}.confirmStatus", "message": "确认状态不合法"})
+        parsed_confirm_date = _parse_date_str(row.confirmDate, f"{row_prefix}.confirmDate", errors)
+        if row.confirmStatus == "已确认" and not parsed_confirm_date:
+            errors.append({"field": f"{row_prefix}.confirmDate", "message": "已确认时必须填写确认日期"})
+        if row.confirmStatus == "退回" and not row.note.strip():
+            errors.append({"field": f"{row_prefix}.note", "message": "退回时必须填写备注"})
+        if project_plan_start and parsed_confirm_date and parsed_confirm_date < project_plan_start:
+            errors.append({"field": f"{row_prefix}.confirmDate", "message": "中心确认日期不能早于项目计划开始日期"})
+        if project_plan_end and parsed_confirm_date and parsed_confirm_date > project_plan_end:
+            errors.append({"field": f"{row_prefix}.confirmDate", "message": "中心确认日期不能晚于项目计划结束日期"})
+
+    if errors:
+        _raise_validation_error(errors)
+
+
+def _build_default_setup_config_from_study(study, sites: list) -> StudySetupConfigData:
+    plan_start = study.plan_start_date.isoformat() if getattr(study, "plan_start_date", None) else ""
+    plan_end = study.plan_end_date.isoformat() if getattr(study, "plan_end_date", None) else ""
+    total_target = getattr(study, "planned_enrollment_count", None)
+    if total_target is None:
+        total_target = 0
+    return StudySetupConfigData(
+        projectMilestones=[],
+        enrollmentPlan={
+            "totalTarget": total_target,
+            "startDate": plan_start,
+            "endDate": plan_end,
+            "monthlyGoalNote": getattr(study, "enrollment_monthly_goal_note", None) or "",
+            "stageBreakdown": getattr(study, "enrollment_stage_breakdown", None) or "",
+        },
+        siteMilestones=[],
+        siteEnrollmentPlans=[],
+        monitoringStrategies=[],
+        centerConfirm=[],
+    )
+
+
+def _to_setup_config_read(
+    record,
+    *,
+    saved_by_name: str | None = None,
+    published_by_name: str | None = None,
+    projection_status: str | None = None,
+    projection_summary: SetupProjectionSummary | None = None,
+) -> StudySetupConfigRead:
+    return StudySetupConfigRead(
+        id=record.id,
+        study_id=record.study_id,
+        version=record.version,
+        data=StudySetupConfigData.model_validate(record.config or {}),
+        publish_status=record.publish_status or "DRAFT",
+        published_data=StudySetupConfigData.model_validate(record.published_config) if record.published_config else None,
+        published_by=record.published_by,
+        published_by_name=published_by_name,
+        published_at=record.published_at,
+        saved_by=record.saved_by,
+        saved_by_name=saved_by_name,
+        projection_status=projection_status,
+        projection_summary=projection_summary,
+        created_at=record.created_at,
+        updated_at=record.updated_at,
+    )
+
+
+def _build_projection_audit_detail(
+    *,
+    projection_status: str,
+    study_updated: bool,
+    site_updated_count: int,
+    site_skipped_count: int,
+    warnings: list[str],
+    skipped_items: list[dict[str, str]],
+) -> str:
+    warning_part = " | ".join(warnings[:5]) if warnings else "-"
+    reason_counter = Counter(item.get("reason") for item in skipped_items if item.get("reason"))
+    reason_summary = ", ".join(f"{reason}:{count}" for reason, count in sorted(reason_counter.items())) if reason_counter else "-"
+    return (
+        "立项配置已发布"
+        f"; projection_status={projection_status}"
+        f"; study_updated={study_updated}"
+        f"; site_updated={site_updated_count}"
+        f"; site_skipped={site_skipped_count}"
+        f"; warnings={warning_part}"
+        f"; skipped_reason_counts={reason_summary}"
+    )
+
+
+def _ensure_study_timeline_valid(
+    *,
+    plan_start_date: date | None,
+    plan_end_date: date | None,
+    visit_window_start_offset: int | None,
+    visit_window_end_offset: int | None,
+) -> None:
+    if plan_start_date and plan_end_date and plan_start_date > plan_end_date:
+        raise HTTPException(status_code=status.HTTP_400_BAD_REQUEST, detail="项目计划结束日期不能早于开始日期")
+    if (
+        visit_window_start_offset is not None
+        and visit_window_end_offset is not None
+        and visit_window_start_offset > visit_window_end_offset
+    ):
+        raise HTTPException(status_code=status.HTTP_400_BAD_REQUEST, detail="访视窗口开始偏移不能晚于结束偏移")
+
+
+def _to_setup_config_version_read(record, *, published_by_name: str | None = None) -> StudySetupConfigVersionRead:
+    return StudySetupConfigVersionRead(
+        id=record.id,
+        study_id=record.study_id,
+        study_setup_config_id=record.study_setup_config_id,
+        version=record.version,
+        display_version=record.display_version,
+        source_version=record.source_version,
+        config=StudySetupConfigData.model_validate(record.config or {}),
+        published_by=record.published_by,
+        published_by_name=published_by_name,
+        published_at=record.published_at,
+        created_at=record.created_at,
+    )
+
+
+def _top_level_diff_summary(old: dict | None, new: dict | None) -> str:
+    old = old or {}
+    new = new or {}
+    changed = []
+    for key in ("projectMilestones", "enrollmentPlan", "siteMilestones", "siteEnrollmentPlans", "monitoringStrategies", "centerConfirm"):
+        if old.get(key) != new.get(key):
+            changed.append(key)
+    return "变更模块：" + (", ".join(changed) if changed else "无")
+
 
 @router.post("/", response_model=StudyRead, status_code=status.HTTP_201_CREATED, dependencies=[Depends(require_roles(["ADMIN"]))])
 async def create_study(
@@ -21,6 +342,15 @@ async def create_study(
     db: AsyncSession = Depends(get_db_session),
     current_user=Depends(get_current_user),
 ) -> StudyRead:
+    _ensure_study_timeline_valid(
+        plan_start_date=study_in.plan_start_date,
+        plan_end_date=study_in.plan_end_date,
+        visit_window_start_offset=study_in.visit_window_start_offset,
+        visit_window_end_offset=study_in.visit_window_end_offset,
+    )
+    study_in.code = study_in.code.strip()
+    if not study_in.code:
+        raise HTTPException(status_code=status.HTTP_422_UNPROCESSABLE_ENTITY, detail="项目编号不能为空")
     existing = await study_crud.get_by_code(db, study_in.code)
     if existing:
         raise HTTPException(status_code=status.HTTP_409_CONFLICT, detail="项目编号已存在")
@@ -34,6 +364,26 @@ async def create_study(
     )
     await member_crud.add_member(db, study.id, member_in)
 
+    # 初始化立项配置草稿，并回填可映射的项目信息字段
+    default_setup_data = _build_default_setup_config_from_study(study, [])
+    setup_record, _ = await study_setup_config_crud.upsert(
+        db,
+        study.id,
+        expected_version=None,
+        data=default_setup_data,
+        saved_by=current_user.id,
+    )
+    await audit_crud.log_action(
+        db,
+        study_id=study.id,
+        entity_type="study_setup_config",
+        entity_id=setup_record.id,
+        action="CREATE_SETUP_CONFIG",
+        detail="初始化立项配置（创建项目时回填基础信息）",
+        operator_id=current_user.id,
+        operator_role=current_user.role,
+    )
+    
     return study
 
 
@@ -90,6 +440,25 @@ async def update_study(
         if existing and existing.id != study.id:
             raise HTTPException(status_code=status.HTTP_409_CONFLICT, detail="项目编号已存在")
 
+    next_plan_start = study_in.plan_start_date if "plan_start_date" in study_in.model_fields_set else study.plan_start_date
+    next_plan_end = study_in.plan_end_date if "plan_end_date" in study_in.model_fields_set else study.plan_end_date
+    next_window_start = (
+        study_in.visit_window_start_offset
+        if "visit_window_start_offset" in study_in.model_fields_set
+        else study.visit_window_start_offset
+    )
+    next_window_end = (
+        study_in.visit_window_end_offset
+        if "visit_window_end_offset" in study_in.model_fields_set
+        else study.visit_window_end_offset
+    )
+    _ensure_study_timeline_valid(
+        plan_start_date=next_plan_start,
+        plan_end_date=next_plan_end,
+        visit_window_start_offset=next_window_start,
+        visit_window_end_offset=next_window_end,
+    )
+    
     updated = await study_crud.update(db, study, study_in)
     return updated
 
@@ -175,3 +544,407 @@ async def unlock_study(
     )
     
     return unlocked_study
+
+
+@router.get(
+    "/{study_id}/setup-config",
+    response_model=StudySetupConfigRead,
+    dependencies=[Depends(require_study_member())],
+)
+async def get_study_setup_config(
+    study_id: uuid.UUID,
+    db: AsyncSession = Depends(get_db_session),
+    current_user=Depends(get_current_user),
+) -> StudySetupConfigRead:
+    study = await study_crud.get(db, study_id)
+    if not study:
+        raise HTTPException(status_code=status.HTTP_404_NOT_FOUND, detail="项目不存在")
+
+    record = await study_setup_config_crud.get_by_study(db, study_id)
+    if not record:
+        sites = await site_crud.list_by_study(db, study_id, skip=0, limit=500, include_inactive=True)
+        default_data = _build_default_setup_config_from_study(study, list(sites))
+        record, _ = await study_setup_config_crud.upsert(
+            db,
+            study_id,
+            expected_version=None,
+            data=default_data,
+            saved_by=current_user.id,
+        )
+        await audit_crud.log_action(
+            db,
+            study_id=study_id,
+            entity_type="study_setup_config",
+            entity_id=record.id,
+            action="CREATE_SETUP_CONFIG",
+            detail="初始化立项配置",
+            operator_id=current_user.id,
+            operator_role=current_user.role,
+        )
+
+    saved_by_name = None
+    published_by_name = None
+    if record.saved_by:
+        user = await user_crud.get_by_id(db, record.saved_by)
+        if user:
+            saved_by_name = user.full_name or user.username or user.email
+    if record.published_by:
+        user = await user_crud.get_by_id(db, record.published_by)
+        if user:
+            published_by_name = user.full_name or user.username or user.email
+
+    return _to_setup_config_read(record, saved_by_name=saved_by_name, published_by_name=published_by_name)
+
+
+@router.put(
+    "/{study_id}/setup-config",
+    response_model=StudySetupConfigRead,
+    dependencies=[Depends(require_study_roles(["PM"])), Depends(require_study_not_locked())],
+)
+async def upsert_study_setup_config(
+    study_id: uuid.UUID,
+    payload: StudySetupConfigUpsert,
+    db: AsyncSession = Depends(get_db_session),
+    current_user=Depends(get_current_user),
+) -> StudySetupConfigRead:
+    study = await study_crud.get(db, study_id)
+    if not study:
+        raise HTTPException(status_code=status.HTTP_404_NOT_FOUND, detail="项目不存在")
+
+    sites = await site_crud.list_by_study(db, study_id, skip=0, limit=1000, include_inactive=True)
+    site_lookup = {str(site.id): site.name or "" for site in sites}
+    _validate_setup_data(
+        payload.data,
+        site_lookup,
+        project_plan_start=getattr(study, "plan_start_date", None),
+        project_plan_end=getattr(study, "plan_end_date", None),
+    )
+
+    existing = await study_setup_config_crud.get_by_study(db, study_id)
+    old_config = dict(existing.config or {}) if existing else {}
+    record, conflict = await study_setup_config_crud.upsert(
+        db,
+        study_id,
+        expected_version=payload.expected_version,
+        data=payload.data,
+        saved_by=current_user.id,
+    )
+    if conflict:
+        _raise_conflict_error()
+    if not record:
+        raise HTTPException(status_code=status.HTTP_500_INTERNAL_SERVER_ERROR, detail="配置保存失败")
+
+    await audit_crud.log_action(
+        db,
+        study_id=study_id,
+        entity_type="study_setup_config",
+        entity_id=record.id,
+        action="UPDATE_SETUP_CONFIG",
+        detail=_top_level_diff_summary(old_config, record.config),
+        operator_id=current_user.id,
+        operator_role=current_user.role,
+    )
+
+    saved_by_name = current_user.full_name or current_user.username or current_user.email
+    published_by_name = None
+    if record.published_by:
+        user = await user_crud.get_by_id(db, record.published_by)
+        if user:
+            published_by_name = user.full_name or user.username or user.email
+    return _to_setup_config_read(record, saved_by_name=saved_by_name, published_by_name=published_by_name)
+
+
+@router.post(
+    "/{study_id}/setup-config/publish",
+    response_model=StudySetupConfigRead,
+    dependencies=[Depends(require_study_roles(["PM"])), Depends(require_study_not_locked())],
+)
+async def publish_study_setup_config(
+    study_id: uuid.UUID,
+    payload: StudySetupConfigPublish,
+    db: AsyncSession = Depends(get_db_session),
+    current_user=Depends(get_current_user),
+) -> StudySetupConfigRead:
+    study = await study_crud.get(db, study_id)
+    if not study:
+        raise HTTPException(status_code=status.HTTP_404_NOT_FOUND, detail="项目不存在")
+
+    record = await study_setup_config_crud.get_by_study(db, study_id)
+    if not record:
+        raise HTTPException(status_code=status.HTTP_404_NOT_FOUND, detail="请先保存立项配置草稿")
+
+    sites = await site_crud.list_by_study(db, study_id, skip=0, limit=1000, include_inactive=True)
+    site_lookup = {str(site.id): site.name or "" for site in sites}
+    _validate_setup_data(
+        StudySetupConfigData.model_validate(record.config or {}),
+        site_lookup,
+        project_plan_start=getattr(study, "plan_start_date", None),
+        project_plan_end=getattr(study, "plan_end_date", None),
+    )
+
+    published, conflict = await study_setup_config_crud.publish(
+        db,
+        study_id,
+        expected_version=payload.expected_version,
+        published_by=current_user.id,
+        auto_commit=False,
+    )
+    if conflict:
+        await db.rollback()
+        _raise_conflict_error()
+    if not published:
+        await db.rollback()
+        raise HTTPException(status_code=status.HTTP_500_INTERNAL_SERVER_ERROR, detail="配置发布失败")
+
+    try:
+        projection = await apply_setup_projection_on_publish(
+            db,
+            study_id=study_id,
+            setup_data=StudySetupConfigData.model_validate(published.config or {}),
+            operator_id=current_user.id,
+        )
+        projection_summary = SetupProjectionSummary(
+            study_updated=projection.study_updated,
+            site_updated_count=projection.site_updated_count,
+            site_skipped_count=projection.site_skipped_count,
+            warnings=projection.warnings,
+            skipped_items=[
+                {"site_id": item.site_id, "reason": item.reason}
+                for item in projection.skipped_items
+            ],
+        )
+        await audit_crud.log_action(
+            db,
+            study_id=study_id,
+            entity_type="study_setup_config",
+            entity_id=published.id,
+            action="PUBLISH_SETUP_CONFIG",
+            detail=_build_projection_audit_detail(
+                projection_status=projection.status,
+                study_updated=projection.study_updated,
+                site_updated_count=projection.site_updated_count,
+                site_skipped_count=projection.site_skipped_count,
+                warnings=projection.warnings,
+                skipped_items=[{"site_id": item.site_id, "reason": item.reason} for item in projection.skipped_items],
+            ),
+            operator_id=current_user.id,
+            operator_role=current_user.role,
+            auto_commit=False,
+        )
+        await db.commit()
+    except Exception:
+        await db.rollback()
+        raise HTTPException(status_code=status.HTTP_500_INTERNAL_SERVER_ERROR, detail="发布失败：联动同步异常")
+
+    operator_name = current_user.full_name or current_user.username or current_user.email
+    await db.refresh(published)
+    return _to_setup_config_read(
+        published,
+        saved_by_name=operator_name,
+        published_by_name=operator_name,
+        projection_status=projection.status,
+        projection_summary=projection_summary,
+    )
+
+
+@router.get(
+    "/{study_id}/setup-config/versions",
+    response_model=list[StudySetupConfigVersionRead],
+    dependencies=[Depends(require_study_member())],
+)
+async def list_study_setup_config_versions(
+    study_id: uuid.UUID,
+    db: AsyncSession = Depends(get_db_session),
+) -> list[StudySetupConfigVersionRead]:
+    study = await study_crud.get(db, study_id)
+    if not study:
+        raise HTTPException(status_code=status.HTTP_404_NOT_FOUND, detail="项目不存在")
+
+    versions = await study_setup_config_crud.list_versions(db, study_id)
+    user_ids = {item.published_by for item in versions if item.published_by}
+    name_map: dict[uuid.UUID, str] = {}
+    for user_id in user_ids:
+        user = await user_crud.get_by_id(db, user_id)
+        if user:
+            name_map[user_id] = user.full_name or user.username or user.email
+    return [
+        _to_setup_config_version_read(item, published_by_name=name_map.get(item.published_by) if item.published_by else None)
+        for item in versions
+    ]
+
+
+@router.post(
+    "/{study_id}/setup-config/rollback",
+    response_model=StudySetupConfigRead,
+    dependencies=[Depends(require_study_roles(["PM"])), Depends(require_study_not_locked())],
+)
+async def rollback_study_setup_config(
+    study_id: uuid.UUID,
+    payload: StudySetupConfigRollback,
+    db: AsyncSession = Depends(get_db_session),
+    current_user=Depends(get_current_user),
+) -> StudySetupConfigRead:
+    study = await study_crud.get(db, study_id)
+    if not study:
+        raise HTTPException(status_code=status.HTTP_404_NOT_FOUND, detail="项目不存在")
+
+    record, conflict, target_missing = await study_setup_config_crud.rollback_to_version(
+        db,
+        study_id,
+        expected_version=payload.expected_version,
+        target_version=payload.target_version,
+        saved_by=current_user.id,
+    )
+    if conflict:
+        _raise_conflict_error()
+    if target_missing:
+        raise HTTPException(status_code=status.HTTP_404_NOT_FOUND, detail="目标版本不存在")
+    if not record:
+        raise HTTPException(status_code=status.HTTP_500_INTERNAL_SERVER_ERROR, detail="版本回滚失败")
+
+    await audit_crud.log_action(
+        db,
+        study_id=study_id,
+        entity_type="study_setup_config",
+        entity_id=record.id,
+        action="ROLLBACK_SETUP_CONFIG",
+        detail=f"立项配置已回滚到发布版本 v{payload.target_version}",
+        operator_id=current_user.id,
+        operator_role=current_user.role,
+    )
+    operator_name = current_user.full_name or current_user.username or current_user.email
+    published_by_name = None
+    if record.published_by:
+        user = await user_crud.get_by_id(db, record.published_by)
+        if user:
+            published_by_name = user.full_name or user.username or user.email
+    return _to_setup_config_read(record, saved_by_name=operator_name, published_by_name=published_by_name)
+
+
+@router.delete(
+    "/{study_id}/setup-config/versions/{target_version}",
+    status_code=status.HTTP_204_NO_CONTENT,
+    dependencies=[Depends(require_study_roles(["PM"])), Depends(require_study_not_locked())],
+)
+async def delete_study_setup_config_version(
+    study_id: uuid.UUID,
+    target_version: int,
+    db: AsyncSession = Depends(get_db_session),
+    current_user=Depends(get_current_user),
+) -> None:
+    study = await study_crud.get(db, study_id)
+    if not study:
+        raise HTTPException(status_code=status.HTTP_404_NOT_FOUND, detail="项目不存在")
+
+    versions = await study_setup_config_crud.list_versions(db, study_id)
+    if not versions:
+        raise HTTPException(status_code=status.HTTP_404_NOT_FOUND, detail="目标版本不存在")
+    latest_version = max(item.version for item in versions)
+    if target_version == latest_version:
+        raise HTTPException(status_code=status.HTTP_400_BAD_REQUEST, detail="最新发布版本不能删除")
+
+    deleted = await study_setup_config_crud.delete_version(
+        db,
+        study_id,
+        target_version=target_version,
+    )
+    if not deleted:
+        raise HTTPException(status_code=status.HTTP_404_NOT_FOUND, detail="目标版本不存在")
+
+    await audit_crud.log_action(
+        db,
+        study_id=study_id,
+        entity_type="study_setup_config",
+        entity_id=study_id,
+        action="DELETE_SETUP_CONFIG_VERSION",
+        detail=f"删除发布版本快照 v{target_version}",
+        operator_id=current_user.id,
+        operator_role=current_user.role,
+    )
+
+
+@router.get(
+    "/{study_id}/setup-config/export-excel",
+    dependencies=[Depends(require_study_member())],
+)
+async def export_study_setup_config_excel(
+    study_id: uuid.UUID,
+    db: AsyncSession = Depends(get_db_session),
+    current_user=Depends(get_current_user),
+) -> StreamingResponse:
+    config = await get_study_setup_config(study_id=study_id, db=db, current_user=current_user)
+    study = await study_crud.get(db, study_id)
+    file_bytes = export_setup_config_excel(config.data)
+    filename = f"setup-config-{study.code if study else study_id}.xlsx"
+    return StreamingResponse(
+        BytesIO(file_bytes),
+        media_type="application/vnd.openxmlformats-officedocument.spreadsheetml.sheet",
+        headers={"Content-Disposition": f'attachment; filename="{filename}"'},
+    )
+
+
+@router.post(
+    "/{study_id}/setup-config/import-excel",
+    response_model=StudySetupConfigRead,
+    dependencies=[Depends(require_study_roles(["PM"])), Depends(require_study_not_locked())],
+)
+async def import_study_setup_config_excel(
+    study_id: uuid.UUID,
+    file: UploadFile = File(...),
+    expected_version: int | None = Form(default=None),
+    db: AsyncSession = Depends(get_db_session),
+    current_user=Depends(get_current_user),
+) -> StudySetupConfigRead:
+    if not (file.filename or "").lower().endswith(".xlsx"):
+        raise HTTPException(status_code=status.HTTP_400_BAD_REQUEST, detail="请上传 .xlsx 格式文件")
+
+    study = await study_crud.get(db, study_id)
+    if not study:
+        raise HTTPException(status_code=status.HTTP_404_NOT_FOUND, detail="项目不存在")
+
+    try:
+        payload_data = import_setup_config_excel(await file.read())
+    except Exception:
+        raise HTTPException(status_code=status.HTTP_400_BAD_REQUEST, detail="Excel解析失败，请检查模板格式")
+
+    sites = await site_crud.list_by_study(db, study_id, skip=0, limit=1000, include_inactive=True)
+    site_lookup = {str(site.id): site.name or "" for site in sites}
+    _validate_setup_data(
+        payload_data,
+        site_lookup,
+        project_plan_start=getattr(study, "plan_start_date", None),
+        project_plan_end=getattr(study, "plan_end_date", None),
+    )
+
+    existing = await study_setup_config_crud.get_by_study(db, study_id)
+    old_config = dict(existing.config or {}) if existing else {}
+    record, conflict = await study_setup_config_crud.upsert(
+        db,
+        study_id,
+        expected_version=expected_version,
+        data=payload_data,
+        saved_by=current_user.id,
+    )
+    if conflict:
+        _raise_conflict_error()
+    if not record:
+        raise HTTPException(status_code=status.HTTP_500_INTERNAL_SERVER_ERROR, detail="配置导入失败")
+
+    await audit_crud.log_action(
+        db,
+        study_id=study_id,
+        entity_type="study_setup_config",
+        entity_id=record.id,
+        action="IMPORT_SETUP_CONFIG_EXCEL",
+        detail=_top_level_diff_summary(old_config, record.config),
+        operator_id=current_user.id,
+        operator_role=current_user.role,
+    )
+
+    saved_by_name = current_user.full_name or current_user.username or current_user.email
+    published_by_name = None
+    if record.published_by:
+        user = await user_crud.get_by_id(db, record.published_by)
+        if user:
+            published_by_name = user.full_name or user.username or user.email
+    return _to_setup_config_read(record, saved_by_name=saved_by_name, published_by_name=published_by_name)

backend/app/api/v1/subjects.py

@@ -85,16 +85,29 @@ async def list_subjects(
         return []
     subject_ids = [subject.id for subject in subject_list]
     ae_rows = await db.execute(
-        select(AdverseEvent.subject_id).where(
+        select(AdverseEvent.subject_id, AdverseEvent.is_sae, AdverseEvent.is_susar).where(
             AdverseEvent.study_id == study_id,
             AdverseEvent.subject_id.in_(subject_ids),
         )
     )
-    ae_subject_ids = {row[0] for row in ae_rows.all() if row[0]}
+    ae_flags: dict[uuid.UUID, dict[str, bool]] = {}
+    for row in ae_rows.all():
+        sid = row[0]
+        if not sid:
+            continue
+        if sid not in ae_flags:
+            ae_flags[sid] = {"has_ae": True, "has_sae": False, "has_susar": False}
+        if row[1]:
+            ae_flags[sid]["has_sae"] = True
+        if row[2]:
+            ae_flags[sid]["has_susar"] = True
     result: list[SubjectRead] = []
     for subject in subject_list:
         data = SubjectRead.model_validate(subject)
-        data.has_ae = subject.id in ae_subject_ids
+        flags = ae_flags.get(subject.id, {"has_ae": False, "has_sae": False, "has_susar": False})
+        data.has_ae = flags["has_ae"]
+        data.has_sae = flags["has_sae"]
+        data.has_susar = flags["has_susar"]
         result.append(data)
     return result
 
@@ -120,12 +133,21 @@ async def get_subject(
     await _ensure_subject_active(db, subject)
     data = SubjectRead.model_validate(subject)
     ae_row = await db.execute(
-        select(AdverseEvent.id).where(
+        select(AdverseEvent.is_sae, AdverseEvent.is_susar).where(
             AdverseEvent.study_id == study_id,
             AdverseEvent.subject_id == subject.id,
-        ).limit(1)
         )
-    data.has_ae = ae_row.scalar_one_or_none() is not None
+    )
+    ae_flags = {"has_ae": False, "has_sae": False, "has_susar": False}
+    for row in ae_row.all():
+        ae_flags["has_ae"] = True
+        if row[0]:
+            ae_flags["has_sae"] = True
+        if row[1]:
+            ae_flags["has_susar"] = True
+    data.has_ae = ae_flags["has_ae"]
+    data.has_sae = ae_flags["has_sae"]
+    data.has_susar = ae_flags["has_susar"]
     return data
 
 

backend/app/api/v1/visits.py

@@ -62,6 +62,20 @@ async def create_visit(
     await _ensure_subject_active(db, subject)
     if visit_in.subject_id != subject_id:
         raise HTTPException(status_code=status.HTTP_400_BAD_REQUEST, detail="参与者不匹配")
+    if visit_in.window_start and visit_in.window_end and visit_in.window_start > visit_in.window_end:
+        raise HTTPException(status_code=status.HTTP_400_BAD_REQUEST, detail="访视窗口结束日期不能早于开始日期")
+    if (
+        visit_in.planned_date
+        and visit_in.window_start
+        and visit_in.planned_date < visit_in.window_start
+    ):
+        raise HTTPException(status_code=status.HTTP_400_BAD_REQUEST, detail="计划访视日期不能早于访视窗口开始日期")
+    if (
+        visit_in.planned_date
+        and visit_in.window_end
+        and visit_in.planned_date > visit_in.window_end
+    ):
+        raise HTTPException(status_code=status.HTTP_400_BAD_REQUEST, detail="计划访视日期不能晚于访视窗口结束日期")
     next_visit_code = await visit_crud.get_next_visit_code(db, subject_id)
     if next_visit_code == "V1" and not visit_in.planned_date:
         raise HTTPException(status_code=status.HTTP_400_BAD_REQUEST, detail="首次新增访视必须填写计划访视日期")
@@ -119,6 +133,12 @@ async def update_visit(
         raise HTTPException(status_code=status.HTTP_404_NOT_FOUND, detail="访视不存在")
     if visit_in.status == "DONE" and not visit_in.actual_date:
         raise HTTPException(status_code=status.HTTP_400_BAD_REQUEST, detail="状态为已完成时必须填写实际日期")
+    if visit.window_start and visit.window_end and visit.window_start > visit.window_end:
+        raise HTTPException(status_code=status.HTTP_400_BAD_REQUEST, detail="当前访视窗口配置异常，请先修复窗口日期")
+    if visit_in.actual_date and visit.window_start and visit_in.actual_date < visit.window_start:
+        raise HTTPException(status_code=status.HTTP_400_BAD_REQUEST, detail="实际访视日期不能早于访视窗口开始日期")
+    if visit_in.actual_date and visit.window_end and visit_in.actual_date > visit.window_end:
+        raise HTTPException(status_code=status.HTTP_400_BAD_REQUEST, detail="实际访视日期不能晚于访视窗口结束日期")
     updated = await visit_crud.update_visit(db, visit, visit_in)
     detail = None
     if visit_in.status:

backend/app/crud/ae.py

@@ -64,12 +64,14 @@ async def create_ae(
         term=ae_in.term,
         onset_date=ae_in.onset_date,
         resolution_date=None,
-        seriousness=str(ae_in.seriousness),
-        severity=str(ae_in.seriousness),
+        seriousness=ae_in.seriousness.value,
+        severity=ae_in.seriousness.value,
         causality=ae_in.causality,
         action_taken=None,
         outcome=ae_in.outcome,
         reported_to_sponsor=False,
+        is_sae=bool(ae_in.is_sae or ae_in.is_susar),
+        is_susar=bool(ae_in.is_susar),
         report_due_date=due_date,
         status="NEW",
         description=ae_in.description,
@@ -125,8 +127,14 @@ async def list_ae(
 
 async def update_ae(db: AsyncSession, study_id: uuid.UUID, ae: AdverseEvent, ae_in: AEUpdate) -> AdverseEvent:
     update_data = ae_in.model_dump(exclude_unset=True)
+    if "is_susar" in update_data and update_data["is_susar"]:
+        update_data["is_sae"] = True
+    if "is_sae" in update_data and update_data["is_sae"] is False:
+        update_data["is_susar"] = False
     if "seriousness" in update_data:
-        update_data["seriousness"] = str(update_data["seriousness"])
+        severity_value = update_data["seriousness"].value if hasattr(update_data["seriousness"], "value") else str(update_data["seriousness"])
+        update_data["seriousness"] = severity_value
+        update_data["severity"] = severity_value
     if "subject_id" in update_data:
         await _validate_site_subject(db, study_id, None, update_data["subject_id"])
     if "onset_date" in update_data or "seriousness" in update_data:

backend/app/crud/audit.py

@@ -17,6 +17,7 @@ async def log_action(
     detail: str | None,
     operator_id: uuid.UUID,
     operator_role: str,
+    auto_commit: bool = True,
 ) -> AuditLog:
     log = AuditLog(
         study_id=study_id,
@@ -28,8 +29,11 @@ async def log_action(
         operator_role=operator_role,
     )
     db.add(log)
+    if auto_commit:
         await db.commit()
         await db.refresh(log)
+    else:
+        await db.flush()
     return log
 
 

backend/app/crud/site.py

@@ -25,6 +25,7 @@ from app.models.site import Site
 from app.models.special_expense import SpecialExpense
 from app.models.startup_ethics import StartupEthics
 from app.models.startup_feasibility import StartupFeasibility
+from app.models.study_center_confirm import StudyCenterConfirm
 from app.models.subject import Subject
 from app.models.subject_history import SubjectHistory
 from app.models.training_authorization import TrainingAuthorization
@@ -44,6 +45,9 @@ async def create_site(db: AsyncSession, study_id: uuid.UUID, site_in: SiteCreate
         pi_name=site_in.pi_name,
         contact=site_in.contact,
         is_active=site_in.is_active,
+        enrollment_plan_start_date=site_in.enrollment_plan_start_date,
+        enrollment_plan_end_date=site_in.enrollment_plan_end_date,
+        enrollment_plan_note=site_in.enrollment_plan_note,
     )
     db.add(site)
     await db.commit()
@@ -314,6 +318,7 @@ async def delete_site_and_related(db: AsyncSession, site: Site) -> None:
     await db.execute(delete(AdverseEvent).where(AdverseEvent.site_id == site_id))
     await db.execute(delete(FinanceItem).where(FinanceItem.site_id == site_id))
     await db.execute(delete(Subject).where(Subject.site_id == site_id))
+    await db.execute(delete(StudyCenterConfirm).where(StudyCenterConfirm.site_id == site_id))
 
     await db.execute(delete(Milestone).where(Milestone.site_id == site_id))
     await db.execute(delete(KickoffMeeting).where(KickoffMeeting.site_id == site_id))

backend/app/crud/study.py

@@ -9,23 +9,29 @@ from app.schemas.study import StudyCreate, StudyUpdate
 
 
 async def create(db: AsyncSession, study_in: StudyCreate, *, created_by: uuid.UUID | None = None) -> Study:
-    import uuid as uuid_lib  # Import uuid to generate unique code if needed
-
-    code = study_in.code
-    if not code:
-        # Generate a unique code if not provided
-        # Use first 8 chars of a new UUID, uppercase
-        code = f"P-{str(uuid_lib.uuid4())[:8].upper()}"
-
     study = Study(
-        code=code,
+        code=study_in.code.strip(),
         name=study_in.name,
-        # sponsor is removed from schema, but model has it. Set to None/empty or keep existing value if schema had it (which it doesn't now)
-        # If we removed it from schema, study_in.sponsor will fail if we try to access it via .sponsor attribute directly if it's not in the pydantic model anymore.
-        # Since we removed `sponsor` field from StudyCreate, `study_in` object won't have `sponsor` attribute unless we access dict or use default.
-        # However, the Study MODEL still has sponsor. We should set it to None.
-        sponsor=None,
+        project_full_name=study_in.project_full_name,
+        sponsor=study_in.sponsor,
         protocol_no=study_in.protocol_no,
+        lead_unit=study_in.lead_unit,
+        principal_investigator=study_in.principal_investigator,
+        main_pm=study_in.main_pm,
+        research_analysis=study_in.research_analysis,
+        research_product=study_in.research_product,
+        control_product=study_in.control_product,
+        indication=study_in.indication,
+        research_population=study_in.research_population,
+        research_design=study_in.research_design,
+        plan_start_date=study_in.plan_start_date,
+        plan_end_date=study_in.plan_end_date,
+        planned_site_count=study_in.planned_site_count,
+        planned_enrollment_count=study_in.planned_enrollment_count,
+        enrollment_monthly_goal_note=study_in.enrollment_monthly_goal_note,
+        enrollment_stage_breakdown=study_in.enrollment_stage_breakdown,
+        summary_note=study_in.summary_note,
+        objective_note=study_in.objective_note,
         phase=study_in.phase,
         status=study_in.status,
         visit_interval_days=study_in.visit_interval_days,
@@ -114,6 +120,10 @@ async def delete(db: AsyncSession, study_id: uuid.UUID) -> None:
     from app.models.faq_category import FaqCategory
     from app.models.faq_item import FaqItem
     from app.models.faq_reply import FaqReply
+    from app.models.study_setup_config import StudySetupConfig
+    from app.models.study_setup_config_version import StudySetupConfigVersion
+    from app.models.study_monitoring_strategy import StudyMonitoringStrategy
+    from app.models.study_center_confirm import StudyCenterConfirm
     
     # 按依赖关系顺序删除关联数据
     # 1. 删除审计日志
@@ -160,13 +170,21 @@ async def delete(db: AsyncSession, study_id: uuid.UUID) -> None:
     await db.execute(sa_delete(SubjectHistory).where(SubjectHistory.study_id == study_id))
     await db.execute(sa_delete(Subject).where(Subject.study_id == study_id))
     
-    # 13. 删除站点
+    # 13. 删除立项联动实体（需先于站点删除，避免外键约束）
+    await db.execute(sa_delete(StudyMonitoringStrategy).where(StudyMonitoringStrategy.study_id == study_id))
+    await db.execute(sa_delete(StudyCenterConfirm).where(StudyCenterConfirm.study_id == study_id))
+
+    # 14. 删除站点
     await db.execute(sa_delete(Site).where(Site.study_id == study_id))
 
-    # 14. 删除成员
+    # 15. 删除成员
     await db.execute(sa_delete(StudyMember).where(StudyMember.study_id == study_id))
 
-    # 15. 最后删除项目本身
+    # 16. 删除立项配置
+    await db.execute(sa_delete(StudySetupConfigVersion).where(StudySetupConfigVersion.study_id == study_id))
+    await db.execute(sa_delete(StudySetupConfig).where(StudySetupConfig.study_id == study_id))
+
+    # 17. 最后删除项目本身
     await db.execute(sa_delete(Study).where(Study.id == study_id))
     
     await db.commit()

backend/app/crud/study_setup_config.py

@@ -0,0 +1,171 @@
+import uuid
+from datetime import datetime
+
+from sqlalchemy import delete as sa_delete, select
+from sqlalchemy import func
+from sqlalchemy.ext.asyncio import AsyncSession
+
+from app.models.study_setup_config import StudySetupConfig
+from app.models.study_setup_config_version import StudySetupConfigVersion
+from app.schemas.study_setup_config import StudySetupConfigData
+
+
+def _to_storage(data: StudySetupConfigData | dict) -> dict:
+    if isinstance(data, StudySetupConfigData):
+        return data.model_dump(mode="json")
+    return data
+
+
+async def get_by_study(db: AsyncSession, study_id: uuid.UUID) -> StudySetupConfig | None:
+    result = await db.execute(select(StudySetupConfig).where(StudySetupConfig.study_id == study_id))
+    return result.scalar_one_or_none()
+
+
+async def upsert(
+    db: AsyncSession,
+    study_id: uuid.UUID,
+    *,
+    expected_version: int | None,
+    data: StudySetupConfigData | dict,
+    saved_by: uuid.UUID | None,
+) -> tuple[StudySetupConfig | None, bool]:
+    existing = await get_by_study(db, study_id)
+    payload = _to_storage(data)
+    if existing:
+        if expected_version is not None and expected_version != existing.version:
+            return None, True
+        existing.version = existing.version + 1
+        existing.config = payload
+        existing.saved_by = saved_by
+        existing.publish_status = "PUBLISHED" if existing.published_config == payload else "DRAFT"
+        existing.updated_at = datetime.utcnow()
+        await db.commit()
+        await db.refresh(existing)
+        return existing, False
+
+    record = StudySetupConfig(
+        study_id=study_id,
+        version=1,
+        config=payload,
+        publish_status="DRAFT",
+        saved_by=saved_by,
+    )
+    db.add(record)
+    await db.commit()
+    await db.refresh(record)
+    return record, False
+
+
+async def publish(
+    db: AsyncSession,
+    study_id: uuid.UUID,
+    *,
+    expected_version: int | None,
+    published_by: uuid.UUID | None,
+    auto_commit: bool = True,
+) -> tuple[StudySetupConfig | None, bool]:
+    existing = await get_by_study(db, study_id)
+    if not existing:
+        return None, False
+    if expected_version is not None and expected_version != existing.version:
+        return None, True
+    next_version = existing.version + 1
+    next_display_version_stmt = select(func.max(StudySetupConfigVersion.display_version)).where(
+        StudySetupConfigVersion.study_id == study_id
+    )
+    display_version_result = await db.execute(next_display_version_stmt)
+    current_max_display_version = display_version_result.scalar_one_or_none() or 0
+    next_display_version = current_max_display_version + 1
+    existing.version = next_version
+    existing.publish_status = "PUBLISHED"
+    existing.published_config = existing.config
+    existing.published_by = published_by
+    existing.published_at = datetime.utcnow()
+    existing.saved_by = published_by
+    existing.updated_at = datetime.utcnow()
+    snapshot = StudySetupConfigVersion(
+        study_setup_config_id=existing.id,
+        study_id=study_id,
+        version=next_version,
+        display_version=next_display_version,
+        source_version=next_version - 1,
+        config=existing.config,
+        published_by=published_by,
+        published_at=existing.published_at,
+    )
+    db.add(snapshot)
+    if auto_commit:
+        await db.commit()
+        await db.refresh(existing)
+    else:
+        await db.flush()
+    return existing, False
+
+
+async def list_versions(db: AsyncSession, study_id: uuid.UUID) -> list[StudySetupConfigVersion]:
+    result = await db.execute(
+        select(StudySetupConfigVersion)
+        .where(StudySetupConfigVersion.study_id == study_id)
+        .order_by(StudySetupConfigVersion.version.desc(), StudySetupConfigVersion.published_at.desc())
+    )
+    return list(result.scalars().all())
+
+
+async def rollback_to_version(
+    db: AsyncSession,
+    study_id: uuid.UUID,
+    *,
+    expected_version: int | None,
+    target_version: int,
+    saved_by: uuid.UUID | None,
+) -> tuple[StudySetupConfig | None, bool, bool]:
+    existing = await get_by_study(db, study_id)
+    if not existing:
+        return None, False, False
+    if expected_version is not None and expected_version != existing.version:
+        return None, True, False
+
+    result = await db.execute(
+        select(StudySetupConfigVersion).where(
+            StudySetupConfigVersion.study_id == study_id,
+            StudySetupConfigVersion.version == target_version,
+        )
+    )
+    target = result.scalar_one_or_none()
+    if not target:
+        return None, False, True
+
+    existing.version = existing.version + 1
+    existing.config = target.config
+    existing.saved_by = saved_by
+    existing.publish_status = "DRAFT"
+    existing.updated_at = datetime.utcnow()
+    await db.commit()
+    await db.refresh(existing)
+    return existing, False, False
+
+
+async def delete_version(
+    db: AsyncSession,
+    study_id: uuid.UUID,
+    *,
+    target_version: int,
+) -> bool:
+    result = await db.execute(
+        select(StudySetupConfigVersion).where(
+            StudySetupConfigVersion.study_id == study_id,
+            StudySetupConfigVersion.version == target_version,
+        )
+    )
+    target = result.scalar_one_or_none()
+    if not target:
+        return False
+    await db.delete(target)
+    await db.commit()
+    return True
+
+
+async def delete_by_study(db: AsyncSession, study_id: uuid.UUID) -> None:
+    await db.execute(sa_delete(StudySetupConfigVersion).where(StudySetupConfigVersion.study_id == study_id))
+    await db.execute(sa_delete(StudySetupConfig).where(StudySetupConfig.study_id == study_id))
+    await db.commit()

backend/app/crud/subject.py

@@ -16,6 +16,27 @@ from app.models.subject import Subject
 from app.schemas.subject import SubjectCreate, SubjectUpdate
 
 
+def _validate_subject_date_chain(
+    *,
+    screening_date: date | None,
+    consent_date: date | None,
+    enrollment_date: date | None,
+    completion_date: date | None,
+) -> None:
+    if screening_date and consent_date and consent_date < screening_date:
+        raise ValueError("知情同意日期不能早于筛选日期")
+    if screening_date and enrollment_date and enrollment_date < screening_date:
+        raise ValueError("入组日期不能早于筛选日期")
+    if consent_date and enrollment_date and enrollment_date < consent_date:
+        raise ValueError("入组日期不能早于知情同意日期")
+    if screening_date and completion_date and completion_date < screening_date:
+        raise ValueError("完成日期不能早于筛选日期")
+    if consent_date and completion_date and completion_date < consent_date:
+        raise ValueError("完成日期不能早于知情同意日期")
+    if enrollment_date and completion_date and completion_date < enrollment_date:
+        raise ValueError("完成日期不能早于入组日期")
+
+
 async def _validate_site(db: AsyncSession, study_id: uuid.UUID, site_id: uuid.UUID) -> None:
     result = await db.execute(select(Site).where(Site.id == site_id))
     site = result.scalar_one_or_none()
@@ -27,6 +48,12 @@ async def _validate_site(db: AsyncSession, study_id: uuid.UUID, site_id: uuid.UU
 
 async def create_subject(db: AsyncSession, study_id: uuid.UUID, subject_in: SubjectCreate) -> Subject:
     await _validate_site(db, study_id, subject_in.site_id)
+    _validate_subject_date_chain(
+        screening_date=subject_in.screening_date,
+        consent_date=subject_in.consent_date,
+        enrollment_date=None,
+        completion_date=None,
+    )
     subject = Subject(
         study_id=study_id,
         site_id=subject_in.site_id,
@@ -121,6 +148,16 @@ async def generate_default_visits(db: AsyncSession, subject: Subject) -> None:
 
 async def update_subject(db: AsyncSession, subject: Subject, subject_in: SubjectUpdate) -> Subject:
     update_data = subject_in.model_dump(exclude_unset=True)
+    next_screening_date = subject.screening_date
+    next_consent_date = update_data.get("consent_date", subject.consent_date)
+    next_enrollment_date = update_data.get("enrollment_date", subject.enrollment_date)
+    next_completion_date = update_data.get("completion_date", subject.completion_date)
+    _validate_subject_date_chain(
+        screening_date=next_screening_date,
+        consent_date=next_consent_date,
+        enrollment_date=next_enrollment_date,
+        completion_date=next_completion_date,
+    )
     if update_data:
         await db.execute(
             sa_update(Subject)

backend/app/db/base.py

@@ -32,3 +32,7 @@ from app.models.subject_history import SubjectHistory  # noqa: F401
 from app.models.faq_category import FaqCategory  # noqa: F401
 from app.models.faq_item import FaqItem  # noqa: F401
 from app.models.faq_reply import FaqReply  # noqa: F401
+from app.models.study_setup_config import StudySetupConfig  # noqa: F401
+from app.models.study_setup_config_version import StudySetupConfigVersion  # noqa: F401
+from app.models.study_monitoring_strategy import StudyMonitoringStrategy  # noqa: F401
+from app.models.study_center_confirm import StudyCenterConfirm  # noqa: F401

backend/app/main.py

@@ -1,5 +1,9 @@
 import asyncio
+import logging
+import re
+import time
 from contextlib import asynccontextmanager
+from collections import defaultdict
 
 from fastapi import FastAPI
 from fastapi.middleware.cors import CORSMiddleware
@@ -14,6 +18,12 @@ from app.db.session import SessionLocal, engine
 from app.services.fee_seed import seed_demo_fees
 from app.services.visit_scheduler import run_daily_lost_visit_job
 
+logger = logging.getLogger("ctms.setup_config")
+UUID_RE = re.compile(
+    r"[0-9a-fA-F]{8}-[0-9a-fA-F]{4}-[0-9a-fA-F]{4}-[0-9a-fA-F]{4}-[0-9a-fA-F]{12}"
+)
+setup_config_stats: dict[str, int] = defaultdict(int)
+
 
 @asynccontextmanager
 async def lifespan(_: FastAPI):
@@ -100,6 +110,62 @@ def create_app() -> FastAPI:
         allow_methods=["*"],
         allow_headers=["*"],
     )
+
+    @app.middleware("http")
+    async def setup_config_monitoring_middleware(request, call_next):
+        path = request.url.path
+        is_setup_config_path = "/api/v1/studies/" in path and "/setup-config" in path
+        started_at = time.perf_counter()
+        try:
+            response = await call_next(request)
+        except Exception:
+            if is_setup_config_path:
+                normalized_path = UUID_RE.sub("{study_id}", path)
+                duration_ms = int((time.perf_counter() - started_at) * 1000)
+                key = f"{request.method} {normalized_path} 5xx"
+                setup_config_stats[key] += 1
+                logger.exception(
+                    "setup_config_request_error method=%s path=%s status=%s duration_ms=%s",
+                    request.method,
+                    normalized_path,
+                    500,
+                    duration_ms,
+                )
+            raise
+
+        if is_setup_config_path:
+            normalized_path = UUID_RE.sub("{study_id}", path)
+            duration_ms = int((time.perf_counter() - started_at) * 1000)
+            status_code = int(response.status_code)
+            status_bucket = f"{status_code // 100}xx"
+            key = f"{request.method} {normalized_path} {status_bucket}"
+            setup_config_stats[key] += 1
+            if status_code >= 500:
+                logger.error(
+                    "setup_config_request method=%s path=%s status=%s duration_ms=%s",
+                    request.method,
+                    normalized_path,
+                    status_code,
+                    duration_ms,
+                )
+            elif status_code >= 400:
+                logger.warning(
+                    "setup_config_request method=%s path=%s status=%s duration_ms=%s",
+                    request.method,
+                    normalized_path,
+                    status_code,
+                    duration_ms,
+                )
+            else:
+                logger.info(
+                    "setup_config_request method=%s path=%s status=%s duration_ms=%s",
+                    request.method,
+                    normalized_path,
+                    status_code,
+                    duration_ms,
+                )
+        return response
+
     register_exception_handlers(app)
 
     @app.get(
@@ -111,6 +177,21 @@ def create_app() -> FastAPI:
     async def health() -> dict[str, str]:
         return {"status": "ok"}
 
+    @app.get(
+        "/health/setup-config-stats",
+        tags=["health"],
+        summary="立项配置接口监控统计",
+        description="返回当前进程内立项配置接口访问计数（按接口+状态段汇总）。",
+    )
+    async def setup_config_health_stats() -> dict[str, dict[str, int]]:
+        summary: dict[str, int] = dict(setup_config_stats)
+        totals = {
+            "2xx": sum(v for k, v in summary.items() if k.endswith(" 2xx")),
+            "4xx": sum(v for k, v in summary.items() if k.endswith(" 4xx")),
+            "5xx": sum(v for k, v in summary.items() if k.endswith(" 5xx")),
+        }
+        return {"totals": totals, "by_endpoint": summary}
+
     app.include_router(api_router, prefix="/api/v1")
     return app
 

backend/app/models/ae.py

@@ -25,6 +25,8 @@ class AdverseEvent(Base):
     action_taken: Mapped[str | None] = mapped_column(Text, nullable=True)
     outcome: Mapped[str | None] = mapped_column(String(50), nullable=True)
     reported_to_sponsor: Mapped[bool] = mapped_column(Boolean, nullable=False, default=False)
+    is_sae: Mapped[bool] = mapped_column(Boolean, nullable=False, default=False)
+    is_susar: Mapped[bool] = mapped_column(Boolean, nullable=False, default=False)
     report_due_date: Mapped[date | None] = mapped_column(Date, nullable=True)
     status: Mapped[str] = mapped_column(String(20), nullable=False, default="NEW")
     description: Mapped[str | None] = mapped_column(Text, nullable=True)

backend/app/models/milestone.py

@@ -20,6 +20,7 @@ class Milestone(Base):
     status: Mapped[str] = mapped_column(String(20), nullable=False, default="NOT_STARTED")
     site_id: Mapped[uuid.UUID | None] = mapped_column(UUID(as_uuid=True), ForeignKey("sites.id"), nullable=True)
     owner_id: Mapped[uuid.UUID | None] = mapped_column(UUID(as_uuid=True), ForeignKey("users.id"), nullable=True)
+    owner_name: Mapped[str | None] = mapped_column(String(255), nullable=True)
     notes: Mapped[str | None] = mapped_column(Text, nullable=True)
     created_at: Mapped[datetime] = mapped_column(DateTime(timezone=True), nullable=False, server_default=func.now())
     updated_at: Mapped[datetime] = mapped_column(

backend/app/models/site.py

@@ -1,7 +1,7 @@
 import uuid
-from datetime import datetime
+from datetime import date, datetime
 
-from sqlalchemy import Boolean, DateTime, ForeignKey, Integer, String, func
+from sqlalchemy import Boolean, Date, DateTime, ForeignKey, Integer, String, Text, func
 from sqlalchemy.dialects.postgresql import UUID
 from sqlalchemy.orm import Mapped, mapped_column
 
@@ -19,5 +19,7 @@ class Site(Base):
     contact: Mapped[str | None] = mapped_column(String(100), nullable=True)
     is_active: Mapped[bool] = mapped_column(Boolean, nullable=False, server_default="true")
     enrollment_target: Mapped[int | None] = mapped_column(Integer, nullable=True)
+    enrollment_plan_start_date: Mapped[date | None] = mapped_column(Date, nullable=True)
+    enrollment_plan_end_date: Mapped[date | None] = mapped_column(Date, nullable=True)
+    enrollment_plan_note: Mapped[str | None] = mapped_column(Text, nullable=True)
     created_at: Mapped[datetime] = mapped_column(DateTime(timezone=True), nullable=False, server_default=func.now())
-

backend/app/models/study.py

@@ -1,7 +1,7 @@
 import uuid
-from datetime import datetime
+from datetime import date, datetime
 
-from sqlalchemy import Boolean, DateTime, ForeignKey, Integer, String, func
+from sqlalchemy import Boolean, Date, DateTime, ForeignKey, Integer, String, Text, func
 from sqlalchemy.dialects.postgresql import UUID
 from sqlalchemy.orm import Mapped, mapped_column
 
@@ -14,8 +14,26 @@ class Study(Base):
     id: Mapped[uuid.UUID] = mapped_column(UUID(as_uuid=True), primary_key=True, default=uuid.uuid4)
     code: Mapped[str] = mapped_column(String(50), unique=True, nullable=False, index=True)
     name: Mapped[str] = mapped_column(String(200), nullable=False)
+    project_full_name: Mapped[str | None] = mapped_column(String(500), nullable=True)
     sponsor: Mapped[str | None] = mapped_column(String(200), nullable=True)
     protocol_no: Mapped[str | None] = mapped_column(String(100), nullable=True)
+    lead_unit: Mapped[str | None] = mapped_column(String(255), nullable=True)
+    principal_investigator: Mapped[str | None] = mapped_column(String(255), nullable=True)
+    main_pm: Mapped[str | None] = mapped_column(String(255), nullable=True)
+    research_analysis: Mapped[str | None] = mapped_column(Text, nullable=True)
+    research_product: Mapped[str | None] = mapped_column(String(255), nullable=True)
+    control_product: Mapped[str | None] = mapped_column(String(255), nullable=True)
+    indication: Mapped[str | None] = mapped_column(String(255), nullable=True)
+    research_population: Mapped[str | None] = mapped_column(String(255), nullable=True)
+    research_design: Mapped[str | None] = mapped_column(Text, nullable=True)
+    plan_start_date: Mapped[date | None] = mapped_column(Date, nullable=True)
+    plan_end_date: Mapped[date | None] = mapped_column(Date, nullable=True)
+    planned_site_count: Mapped[int | None] = mapped_column(Integer, nullable=True)
+    planned_enrollment_count: Mapped[int | None] = mapped_column(Integer, nullable=True)
+    enrollment_monthly_goal_note: Mapped[str | None] = mapped_column(Text, nullable=True)
+    enrollment_stage_breakdown: Mapped[str | None] = mapped_column(Text, nullable=True)
+    summary_note: Mapped[str | None] = mapped_column(Text, nullable=True)
+    objective_note: Mapped[str | None] = mapped_column(Text, nullable=True)
     phase: Mapped[str | None] = mapped_column(String(50), nullable=True)
     status: Mapped[str] = mapped_column(String(20), nullable=False, default="DRAFT")
     is_locked: Mapped[bool] = mapped_column(Boolean, nullable=False, default=False)

backend/app/models/study_center_confirm.py

@@ -0,0 +1,25 @@
+import uuid
+from datetime import date, datetime
+
+from sqlalchemy import Date, DateTime, ForeignKey, String, Text, func
+from sqlalchemy.dialects.postgresql import UUID
+from sqlalchemy.orm import Mapped, mapped_column
+
+from app.db.base_class import Base
+
+
+class StudyCenterConfirm(Base):
+    __tablename__ = "study_center_confirms"
+
+    id: Mapped[uuid.UUID] = mapped_column(UUID(as_uuid=True), primary_key=True, default=uuid.uuid4)
+    study_id: Mapped[uuid.UUID] = mapped_column(UUID(as_uuid=True), ForeignKey("studies.id"), index=True, nullable=False)
+    site_id: Mapped[uuid.UUID] = mapped_column(UUID(as_uuid=True), ForeignKey("sites.id"), index=True, nullable=False)
+    source_setup_item_id: Mapped[str | None] = mapped_column(String(64), nullable=True)
+    confirmer: Mapped[str | None] = mapped_column(String(255), nullable=True)
+    confirm_status: Mapped[str] = mapped_column(String(20), nullable=False)
+    confirm_date: Mapped[date | None] = mapped_column(Date, nullable=True)
+    note: Mapped[str | None] = mapped_column(Text, nullable=True)
+    created_at: Mapped[datetime] = mapped_column(DateTime(timezone=True), nullable=False, server_default=func.now())
+    updated_at: Mapped[datetime] = mapped_column(
+        DateTime(timezone=True), nullable=False, server_default=func.now(), onupdate=func.now()
+    )

backend/app/models/study_monitoring_strategy.py

@@ -0,0 +1,24 @@
+import uuid
+from datetime import datetime
+
+from sqlalchemy import Boolean, DateTime, ForeignKey, String, Text, func
+from sqlalchemy.dialects.postgresql import UUID
+from sqlalchemy.orm import Mapped, mapped_column
+
+from app.db.base_class import Base
+
+
+class StudyMonitoringStrategy(Base):
+    __tablename__ = "study_monitoring_strategies"
+
+    id: Mapped[uuid.UUID] = mapped_column(UUID(as_uuid=True), primary_key=True, default=uuid.uuid4)
+    study_id: Mapped[uuid.UUID] = mapped_column(UUID(as_uuid=True), ForeignKey("studies.id"), index=True, nullable=False)
+    source_setup_item_id: Mapped[str | None] = mapped_column(String(64), nullable=True)
+    strategy_type: Mapped[str] = mapped_column(String(50), nullable=False)
+    detail: Mapped[str] = mapped_column(Text, nullable=False)
+    frequency: Mapped[str] = mapped_column(String(50), nullable=False)
+    enabled: Mapped[bool] = mapped_column(Boolean, nullable=False, default=True)
+    created_at: Mapped[datetime] = mapped_column(DateTime(timezone=True), nullable=False, server_default=func.now())
+    updated_at: Mapped[datetime] = mapped_column(
+        DateTime(timezone=True), nullable=False, server_default=func.now(), onupdate=func.now()
+    )

backend/app/models/study_setup_config.py

@@ -0,0 +1,27 @@
+import uuid
+from datetime import datetime
+
+from sqlalchemy import DateTime, ForeignKey, Integer, UniqueConstraint, func
+from sqlalchemy.dialects.postgresql import JSONB, UUID
+from sqlalchemy.orm import Mapped, mapped_column
+
+from app.db.base_class import Base
+
+
+class StudySetupConfig(Base):
+    __tablename__ = "study_setup_configs"
+    __table_args__ = (UniqueConstraint("study_id", name="uq_study_setup_config_study"),)
+
+    id: Mapped[uuid.UUID] = mapped_column(UUID(as_uuid=True), primary_key=True, default=uuid.uuid4)
+    study_id: Mapped[uuid.UUID] = mapped_column(UUID(as_uuid=True), ForeignKey("studies.id"), nullable=False, index=True)
+    version: Mapped[int] = mapped_column(Integer, nullable=False, default=1)
+    config: Mapped[dict] = mapped_column(JSONB, nullable=False)
+    publish_status: Mapped[str] = mapped_column(default="DRAFT", nullable=False)
+    published_config: Mapped[dict | None] = mapped_column(JSONB, nullable=True)
+    published_by: Mapped[uuid.UUID | None] = mapped_column(UUID(as_uuid=True), ForeignKey("users.id"), nullable=True)
+    published_at: Mapped[datetime | None] = mapped_column(DateTime(timezone=True), nullable=True)
+    saved_by: Mapped[uuid.UUID | None] = mapped_column(UUID(as_uuid=True), ForeignKey("users.id"), nullable=True)
+    created_at: Mapped[datetime] = mapped_column(DateTime(timezone=True), nullable=False, server_default=func.now())
+    updated_at: Mapped[datetime] = mapped_column(
+        DateTime(timezone=True), nullable=False, server_default=func.now(), onupdate=func.now()
+    )

backend/app/models/study_setup_config_version.py

@@ -0,0 +1,29 @@
+import uuid
+from datetime import datetime
+
+from sqlalchemy import DateTime, ForeignKey, Integer, UniqueConstraint, func
+from sqlalchemy.dialects.postgresql import JSONB, UUID
+from sqlalchemy.orm import Mapped, mapped_column
+
+from app.db.base_class import Base
+
+
+class StudySetupConfigVersion(Base):
+    __tablename__ = "study_setup_config_versions"
+    __table_args__ = (
+        UniqueConstraint("study_id", "version", name="uq_setup_config_versions_study_version"),
+        UniqueConstraint("study_id", "display_version", name="uq_setup_config_versions_study_display_version"),
+    )
+
+    id: Mapped[uuid.UUID] = mapped_column(UUID(as_uuid=True), primary_key=True, default=uuid.uuid4)
+    study_setup_config_id: Mapped[uuid.UUID] = mapped_column(
+        UUID(as_uuid=True), ForeignKey("study_setup_configs.id"), nullable=False, index=True
+    )
+    study_id: Mapped[uuid.UUID] = mapped_column(UUID(as_uuid=True), ForeignKey("studies.id"), nullable=False, index=True)
+    version: Mapped[int] = mapped_column(Integer, nullable=False)
+    display_version: Mapped[int] = mapped_column(Integer, nullable=False)
+    source_version: Mapped[int | None] = mapped_column(Integer, nullable=True)
+    config: Mapped[dict] = mapped_column(JSONB, nullable=False)
+    published_by: Mapped[uuid.UUID | None] = mapped_column(UUID(as_uuid=True), ForeignKey("users.id"), nullable=True)
+    published_at: Mapped[datetime] = mapped_column(DateTime(timezone=True), nullable=False, server_default=func.now())
+    created_at: Mapped[datetime] = mapped_column(DateTime(timezone=True), nullable=False, server_default=func.now())

backend/app/schemas/ae.py

@@ -24,6 +24,8 @@ class AECreate(BaseModel):
     causality: Optional[str] = None
     description: Optional[str] = None
     outcome: Optional[str] = None
+    is_sae: bool = False
+    is_susar: bool = False
 
 
 class AEUpdate(BaseModel):
@@ -36,6 +38,8 @@ class AEUpdate(BaseModel):
     action_taken: Optional[str] = None
     outcome: Optional[str] = None
     reported_to_sponsor: Optional[bool] = None
+    is_sae: Optional[bool] = None
+    is_susar: Optional[bool] = None
     status: Optional[str] = None
     description: Optional[str] = None
 
@@ -54,6 +58,8 @@ class AERead(BaseModel):
     action_taken: Optional[str]
     outcome: Optional[str]
     reported_to_sponsor: bool
+    is_sae: bool
+    is_susar: bool
     report_due_date: Optional[date]
     status: str
     description: Optional[str]
@@ -70,6 +76,8 @@ class AERead(BaseModel):
         if value is None:
             return AESeriousness.I
         normalized = str(value).strip().upper()
+        if normalized.startswith("AESERIOUSNESS."):
+            normalized = normalized.split(".", 1)[1]
         digit_map = {
             "1": "I",
             "2": "II",

backend/app/schemas/site.py

@@ -1,5 +1,5 @@
 import uuid
-from datetime import datetime
+from datetime import date, datetime
 from typing import Optional
 
 from pydantic import BaseModel, ConfigDict, Field
@@ -11,7 +11,9 @@ class SiteCreate(BaseModel):
     pi_name: Optional[str] = None
     contact: Optional[str] = None
     is_active: bool = True
-    enrollment_target: Optional[int] = None
+    enrollment_plan_start_date: Optional[date] = None
+    enrollment_plan_end_date: Optional[date] = None
+    enrollment_plan_note: Optional[str] = None
 
 
 class SiteUpdate(BaseModel):
@@ -20,7 +22,9 @@ class SiteUpdate(BaseModel):
     pi_name: Optional[str] = None
     contact: Optional[str] = None
     is_active: Optional[bool] = None
-    enrollment_target: Optional[int] = None
+    enrollment_plan_start_date: Optional[date] = None
+    enrollment_plan_end_date: Optional[date] = None
+    enrollment_plan_note: Optional[str] = None
 
 
 class SiteRead(BaseModel):
@@ -32,6 +36,9 @@ class SiteRead(BaseModel):
     contact: Optional[str]
     is_active: bool
     enrollment_target: Optional[int]
+    enrollment_plan_start_date: Optional[date]
+    enrollment_plan_end_date: Optional[date]
+    enrollment_plan_note: Optional[str]
     created_at: datetime
 
     model_config = ConfigDict(from_attributes=True)

backend/app/schemas/study.py

@@ -1,5 +1,5 @@
 import uuid
-from datetime import datetime
+from datetime import date, datetime
 from typing import Literal, Optional
 
 from pydantic import BaseModel, ConfigDict, Field
@@ -9,8 +9,27 @@ StudyStatus = Literal["DRAFT", "ACTIVE", "CLOSED"]
 
 class StudyCreate(BaseModel):
     name: str = Field(min_length=1)
-    code: Optional[str] = None
+    code: str = Field(min_length=1)
+    project_full_name: Optional[str] = None
+    sponsor: Optional[str] = None
     protocol_no: Optional[str] = None
+    lead_unit: Optional[str] = None
+    principal_investigator: Optional[str] = None
+    main_pm: Optional[str] = None
+    research_analysis: Optional[str] = None
+    research_product: Optional[str] = None
+    control_product: Optional[str] = None
+    indication: Optional[str] = None
+    research_population: Optional[str] = None
+    research_design: Optional[str] = None
+    plan_start_date: Optional[date] = None
+    plan_end_date: Optional[date] = None
+    planned_site_count: Optional[int] = None
+    planned_enrollment_count: Optional[int] = None
+    enrollment_monthly_goal_note: Optional[str] = None
+    enrollment_stage_breakdown: Optional[str] = None
+    summary_note: Optional[str] = None
+    objective_note: Optional[str] = None
     phase: Optional[str] = None
     status: StudyStatus = "DRAFT"
     visit_interval_days: Optional[int] = None
@@ -22,7 +41,26 @@ class StudyCreate(BaseModel):
 class StudyUpdate(BaseModel):
     code: Optional[str] = None
     name: Optional[str] = None
+    project_full_name: Optional[str] = None
+    sponsor: Optional[str] = None
     protocol_no: Optional[str] = None
+    lead_unit: Optional[str] = None
+    principal_investigator: Optional[str] = None
+    main_pm: Optional[str] = None
+    research_analysis: Optional[str] = None
+    research_product: Optional[str] = None
+    control_product: Optional[str] = None
+    indication: Optional[str] = None
+    research_population: Optional[str] = None
+    research_design: Optional[str] = None
+    plan_start_date: Optional[date] = None
+    plan_end_date: Optional[date] = None
+    planned_site_count: Optional[int] = None
+    planned_enrollment_count: Optional[int] = None
+    enrollment_monthly_goal_note: Optional[str] = None
+    enrollment_stage_breakdown: Optional[str] = None
+    summary_note: Optional[str] = None
+    objective_note: Optional[str] = None
     phase: Optional[str] = None
     status: Optional[StudyStatus] = None
     is_locked: Optional[bool] = None
@@ -36,7 +74,26 @@ class StudyRead(BaseModel):
     id: uuid.UUID
     code: str
     name: str
+    project_full_name: Optional[str]
+    sponsor: Optional[str]
     protocol_no: Optional[str]
+    lead_unit: Optional[str]
+    principal_investigator: Optional[str]
+    main_pm: Optional[str]
+    research_analysis: Optional[str]
+    research_product: Optional[str]
+    control_product: Optional[str]
+    indication: Optional[str]
+    research_population: Optional[str]
+    research_design: Optional[str]
+    plan_start_date: Optional[date]
+    plan_end_date: Optional[date]
+    planned_site_count: Optional[int]
+    planned_enrollment_count: Optional[int]
+    enrollment_monthly_goal_note: Optional[str]
+    enrollment_stage_breakdown: Optional[str]
+    summary_note: Optional[str]
+    objective_note: Optional[str]
     phase: Optional[str]
     status: StudyStatus
     is_locked: bool

backend/app/schemas/study_setup_config.py

@@ -0,0 +1,137 @@
+import uuid
+from datetime import datetime
+from typing import Literal
+
+from pydantic import BaseModel, ConfigDict, Field
+
+
+ConfirmStatus = Literal["待确认", "已确认", "退回"]
+MilestoneStatus = Literal["未开始", "进行中", "已完成", "延期"]
+
+
+class ProjectMilestoneItem(BaseModel):
+    id: str
+    name: str = ""
+    planDate: str = ""
+    owner: str = ""
+    remark: str = ""
+    status: MilestoneStatus = "未开始"
+
+
+class EnrollmentPlanItem(BaseModel):
+    totalTarget: int = 0
+    startDate: str = ""
+    endDate: str = ""
+    monthlyGoalNote: str = ""
+    stageBreakdown: str = ""
+
+
+class SiteMilestoneItem(BaseModel):
+    id: str
+    milestone: str = ""
+    planDate: str = ""
+    owner: str = ""
+    remark: str = ""
+    status: MilestoneStatus = "未开始"
+
+
+class SiteEnrollmentPlanItem(BaseModel):
+    id: str
+    siteId: str = ""
+    siteName: str = ""
+    target: int = 0
+    startDate: str = ""
+    endDate: str = ""
+    note: str = ""
+    stageBreakdown: str = ""
+
+
+class MonitoringStrategyItem(BaseModel):
+    id: str
+    strategyType: str = ""
+    detail: str = ""
+    frequency: str = ""
+    updatedAt: str = ""
+    enabled: bool = True
+
+
+class CenterConfirmItem(BaseModel):
+    id: str
+    siteId: str = ""
+    siteName: str = ""
+    confirmer: str = ""
+    confirmStatus: ConfirmStatus = "待确认"
+    confirmDate: str = ""
+    note: str = ""
+
+
+class StudySetupConfigData(BaseModel):
+    projectMilestones: list[ProjectMilestoneItem] = Field(default_factory=list)
+    enrollmentPlan: EnrollmentPlanItem = Field(default_factory=EnrollmentPlanItem)
+    siteMilestones: list[SiteMilestoneItem] = Field(default_factory=list)
+    siteEnrollmentPlans: list[SiteEnrollmentPlanItem] = Field(default_factory=list)
+    monitoringStrategies: list[MonitoringStrategyItem] = Field(default_factory=list)
+    centerConfirm: list[CenterConfirmItem] = Field(default_factory=list)
+
+
+class StudySetupConfigUpsert(BaseModel):
+    expected_version: int | None = None
+    data: StudySetupConfigData
+
+
+class StudySetupConfigPublish(BaseModel):
+    expected_version: int | None = None
+
+
+class StudySetupConfigRollback(BaseModel):
+    expected_version: int | None = None
+    target_version: int
+
+
+class StudySetupConfigVersionRead(BaseModel):
+    id: uuid.UUID
+    study_id: uuid.UUID
+    study_setup_config_id: uuid.UUID
+    version: int
+    display_version: int
+    source_version: int | None = None
+    config: StudySetupConfigData
+    published_by: uuid.UUID | None = None
+    published_by_name: str | None = None
+    published_at: datetime
+    created_at: datetime
+
+    model_config = ConfigDict(from_attributes=True)
+
+
+class SetupProjectionSkippedItem(BaseModel):
+    site_id: str
+    reason: str
+
+
+class SetupProjectionSummary(BaseModel):
+    study_updated: bool = False
+    site_updated_count: int = 0
+    site_skipped_count: int = 0
+    warnings: list[str] = Field(default_factory=list)
+    skipped_items: list[SetupProjectionSkippedItem] = Field(default_factory=list)
+
+
+class StudySetupConfigRead(BaseModel):
+    id: uuid.UUID
+    study_id: uuid.UUID
+    version: int
+    data: StudySetupConfigData
+    publish_status: str
+    published_data: StudySetupConfigData | None = None
+    published_by: uuid.UUID | None = None
+    published_by_name: str | None = None
+    published_at: datetime | None = None
+    saved_by: uuid.UUID | None
+    saved_by_name: str | None = None
+    projection_status: str | None = None
+    projection_summary: SetupProjectionSummary | None = None
+    created_at: datetime
+    updated_at: datetime
+
+    model_config = ConfigDict(from_attributes=True)

backend/app/schemas/subject.py

@@ -34,5 +34,7 @@ class SubjectRead(BaseModel):
     created_at: datetime
     updated_at: datetime
     has_ae: Optional[bool] = None
+    has_sae: Optional[bool] = None
+    has_susar: Optional[bool] = None
 
     model_config = ConfigDict(from_attributes=True)

backend/app/services/setup_config_excel.py

@@ -0,0 +1,246 @@
+from __future__ import annotations
+
+from datetime import date, datetime
+from io import BytesIO
+import random
+from typing import Any
+
+from openpyxl import Workbook, load_workbook
+
+from app.schemas.study_setup_config import StudySetupConfigData
+
+
+def _make_row_id() -> str:
+    return f"{int(datetime.now().timestamp() * 1000)}_{random.randint(1000, 9999)}"
+
+
+def _is_empty(*values: Any) -> bool:
+    return all(v is None or str(v).strip() == "" for v in values)
+
+
+def _sheet_headers(sheet, headers: list[str]) -> None:
+    sheet.append(headers)
+    for idx, title in enumerate(headers, start=1):
+        cell = sheet.cell(row=1, column=idx)
+        cell.value = title
+
+
+def export_setup_config_excel(data: StudySetupConfigData) -> bytes:
+    wb = Workbook()
+
+    ws_guide = wb.active
+    ws_guide.title = "说明"
+    ws_guide.append(["立项配置Excel模板说明"])
+    ws_guide.append(["1. 各业务Sheet首行是表头，不要修改列名。"])
+    ws_guide.append(["2. 可在现有行基础上新增/删除行。"])
+    ws_guide.append(["3. 日期格式建议：YYYY-MM-DD。"])
+    ws_guide.append(["4. 导入后系统会自动校验并回填到立项配置草稿。"])
+
+    ws_pm = wb.create_sheet("项目里程碑")
+    _sheet_headers(ws_pm, ["ID", "里程碑", "计划日期", "负责人", "状态", "备注"])
+    for row in data.projectMilestones:
+        ws_pm.append([row.id, row.name, row.planDate, row.owner, row.status, row.remark])
+
+    ws_plan = wb.create_sheet("项目入组计划")
+    _sheet_headers(ws_plan, ["计划总入组例数", "计划开始日期", "计划结束日期", "月度目标说明", "分阶段计划"])
+    p = data.enrollmentPlan
+    ws_plan.append([p.totalTarget, p.startDate, p.endDate, p.monthlyGoalNote, p.stageBreakdown])
+
+    ws_sm = wb.create_sheet("中心里程碑")
+    _sheet_headers(ws_sm, ["ID", "里程碑", "计划日期", "负责人", "状态", "备注"])
+    for row in data.siteMilestones:
+        ws_sm.append([row.id, row.milestone, row.planDate, row.owner, row.status, row.remark])
+
+    ws_sep = wb.create_sheet("中心入组计划")
+    _sheet_headers(ws_sep, ["ID", "中心ID", "中心名称", "计划例数", "启动日期", "完成日期", "备注", "分阶段计划"])
+    for row in data.siteEnrollmentPlans:
+        ws_sep.append([row.id, row.siteId, row.siteName, row.target, row.startDate, row.endDate, row.note, row.stageBreakdown])
+
+    ws_ms = wb.create_sheet("监查计划策略")
+    _sheet_headers(ws_ms, ["ID", "监查类型", "策略详情", "监查次数", "更新时间", "是否启用"])
+    for row in data.monitoringStrategies:
+        ws_ms.append([row.id, row.strategyType, row.detail, row.frequency, row.updatedAt, "是" if row.enabled else "否"])
+
+    ws_cc = wb.create_sheet("中心确认")
+    _sheet_headers(ws_cc, ["ID", "中心ID", "中心名称", "确认人", "确认状态", "确认日期", "备注"])
+    for row in data.centerConfirm:
+        ws_cc.append([row.id, row.siteId, row.siteName, row.confirmer, row.confirmStatus, row.confirmDate, row.note])
+
+    bio = BytesIO()
+    wb.save(bio)
+    return bio.getvalue()
+
+
+def _to_int(value: Any, default: int = 0) -> int:
+    if value is None or str(value).strip() == "":
+        return default
+    try:
+        return int(float(str(value)))
+    except (TypeError, ValueError):
+        return default
+
+
+def _to_date_str(value: Any) -> str:
+    if value is None:
+        return ""
+    if isinstance(value, datetime):
+        return value.date().isoformat()
+    if isinstance(value, date):
+        return value.isoformat()
+    return str(value).strip()
+
+
+def _to_datetime_str(value: Any) -> str:
+    if value is None:
+        return ""
+    if isinstance(value, datetime):
+        return value.strftime("%Y-%m-%d %H:%M:%S")
+    return str(value).strip()
+
+
+def _to_bool(value: Any, default: bool = True) -> bool:
+    if value is None:
+        return default
+    v = str(value).strip().lower()
+    if v in {"1", "true", "yes", "y", "是", "启用"}:
+        return True
+    if v in {"0", "false", "no", "n", "否", "禁用"}:
+        return False
+    return default
+
+
+def import_setup_config_excel(file_bytes: bytes) -> StudySetupConfigData:
+    wb = load_workbook(filename=BytesIO(file_bytes), data_only=True)
+
+    project_milestones = []
+    ws = wb["项目里程碑"] if "项目里程碑" in wb.sheetnames else None
+    if ws:
+        for row in ws.iter_rows(min_row=2, values_only=True):
+            rid, name, plan_date, owner, status, remark = row[:6]
+            if _is_empty(rid, name, plan_date, owner, status, remark):
+                continue
+            project_milestones.append(
+                {
+                    "id": str(rid).strip() if rid else _make_row_id(),
+                    "name": str(name or "").strip(),
+                    "planDate": _to_date_str(plan_date),
+                    "owner": str(owner or "").strip(),
+                    "status": str(status or "未开始").strip() or "未开始",
+                    "remark": str(remark or "").strip(),
+                }
+            )
+
+    enrollment_plan = {
+        "totalTarget": 0,
+        "startDate": "",
+        "endDate": "",
+        "monthlyGoalNote": "",
+        "stageBreakdown": "",
+    }
+    ws = wb["项目入组计划"] if "项目入组计划" in wb.sheetnames else None
+    if ws:
+        first = next(ws.iter_rows(min_row=2, values_only=True), None)
+        if first:
+            enrollment_plan = {
+                "totalTarget": _to_int(first[0], 0),
+                "startDate": _to_date_str(first[1]),
+                "endDate": _to_date_str(first[2]),
+                "monthlyGoalNote": str(first[3] or "").strip(),
+                "stageBreakdown": str(first[4] or "").strip(),
+            }
+
+    site_milestones = []
+    ws = wb["中心里程碑"] if "中心里程碑" in wb.sheetnames else None
+    if ws:
+        for row in ws.iter_rows(min_row=2, values_only=True):
+            raw_status = None
+            if len(row) >= 8:
+                rid, site_id, site_name, milestone, plan_date, owner, raw_status, remark = row[:8]
+                _ = (site_id, site_name)
+            elif len(row) == 7:
+                # Backward compatibility: old template has no status column and includes center columns.
+                rid, site_id, site_name, milestone, plan_date, owner, remark = row[:7]
+                _ = (site_id, site_name)
+            else:
+                rid, milestone, plan_date, owner, raw_status, remark = row[:6]
+            if _is_empty(rid, milestone, plan_date, owner, raw_status, remark):
+                continue
+            status = str(raw_status or "未开始").strip() or "未开始"
+            site_milestones.append(
+                {
+                    "id": str(rid).strip() if rid else _make_row_id(),
+                    "milestone": str(milestone or "").strip(),
+                    "planDate": _to_date_str(plan_date),
+                    "owner": str(owner or "").strip(),
+                    "status": status,
+                    "remark": str(remark or "").strip(),
+                }
+            )
+
+    site_enrollment_plans = []
+    ws = wb["中心入组计划"] if "中心入组计划" in wb.sheetnames else None
+    if ws:
+        for row in ws.iter_rows(min_row=2, values_only=True):
+            rid, site_id, site_name, target, start_date, end_date, note, stage_breakdown = (list(row[:8]) + [None] * 8)[:8]
+            if _is_empty(rid, site_id, site_name, target, start_date, end_date, note, stage_breakdown):
+                continue
+            site_enrollment_plans.append(
+                {
+                    "id": str(rid).strip() if rid else _make_row_id(),
+                    "siteId": str(site_id or "").strip(),
+                    "siteName": str(site_name or "").strip(),
+                    "target": _to_int(target, 0),
+                    "startDate": _to_date_str(start_date),
+                    "endDate": _to_date_str(end_date),
+                    "note": str(note or "").strip(),
+                    "stageBreakdown": str(stage_breakdown or "").strip(),
+                }
+            )
+
+    monitoring_strategies = []
+    ws = wb["监查计划策略"] if "监查计划策略" in wb.sheetnames else None
+    if ws:
+        for row in ws.iter_rows(min_row=2, values_only=True):
+            rid, strategy_type, detail, frequency, updated_at, enabled = row[:6]
+            if _is_empty(rid, strategy_type, detail, frequency, updated_at, enabled):
+                continue
+            monitoring_strategies.append(
+                {
+                    "id": str(rid).strip() if rid else _make_row_id(),
+                    "strategyType": str(strategy_type or "").strip(),
+                    "detail": str(detail or "").strip(),
+                    "frequency": str(frequency or "").strip(),
+                    "updatedAt": _to_datetime_str(updated_at) or datetime.now().strftime("%Y-%m-%d %H:%M:%S"),
+                    "enabled": _to_bool(enabled, True),
+                }
+            )
+
+    center_confirm = []
+    ws = wb["中心确认"] if "中心确认" in wb.sheetnames else None
+    if ws:
+        for row in ws.iter_rows(min_row=2, values_only=True):
+            rid, site_id, site_name, confirmer, confirm_status, confirm_date, note = row[:7]
+            if _is_empty(rid, site_id, site_name, confirmer, confirm_status, confirm_date, note):
+                continue
+            center_confirm.append(
+                {
+                    "id": str(rid).strip() if rid else _make_row_id(),
+                    "siteId": str(site_id or "").strip(),
+                    "siteName": str(site_name or "").strip(),
+                    "confirmer": str(confirmer or "").strip(),
+                    "confirmStatus": str(confirm_status or "待确认").strip() or "待确认",
+                    "confirmDate": _to_date_str(confirm_date),
+                    "note": str(note or "").strip(),
+                }
+            )
+
+    return StudySetupConfigData.model_validate(
+        {
+            "projectMilestones": project_milestones,
+            "enrollmentPlan": enrollment_plan,
+            "siteMilestones": site_milestones,
+            "siteEnrollmentPlans": site_enrollment_plans,
+            "monitoringStrategies": monitoring_strategies,
+            "centerConfirm": center_confirm,
+        }
+    )

backend/app/services/setup_config_projection.py

@@ -0,0 +1,387 @@
+import uuid
+from datetime import date
+from typing import Literal
+
+from pydantic import BaseModel, Field
+from sqlalchemy import delete, or_, select
+from sqlalchemy.ext.asyncio import AsyncSession
+
+from app.models.milestone import Milestone
+from app.models.site import Site
+from app.models.study import Study
+from app.models.study_center_confirm import StudyCenterConfirm
+from app.models.study_monitoring_strategy import StudyMonitoringStrategy
+from app.models.user import User
+from app.schemas.study_setup_config import StudySetupConfigData
+
+PROJECT_MILESTONE_TYPE = "SETUP_PROJECT_MILESTONE"
+SITE_MILESTONE_TYPE = "SETUP_SITE_MILESTONE"
+MILESTONE_STATUS_MAP = {
+    "未开始": "NOT_STARTED",
+    "进行中": "IN_PROGRESS",
+    "已完成": "DONE",
+    "延期": "BLOCKED",
+}
+
+
+def _map_milestone_status(raw_status: str | None) -> str | None:
+    normalized = (raw_status or "").strip()
+    if not normalized:
+        return "NOT_STARTED"
+    return MILESTONE_STATUS_MAP.get(normalized)
+
+
+class SetupProjectionSkippedItem(BaseModel):
+    site_id: str
+    reason: str
+
+
+class SetupProjectionResult(BaseModel):
+    status: Literal["success", "partial_success", "failed"]
+    study_updated: bool = False
+    site_updated_count: int = 0
+    site_skipped_count: int = 0
+    warnings: list[str] = Field(default_factory=list)
+    skipped_items: list[SetupProjectionSkippedItem] = Field(default_factory=list)
+
+
+def _parse_date(value: str) -> date | None:
+    if not value:
+        return None
+    try:
+        return date.fromisoformat(value)
+    except ValueError:
+        return None
+
+
+def _normalize_text(value: str | None) -> str | None:
+    if value is None:
+        return None
+    normalized = value.strip()
+    return normalized or None
+
+
+async def _build_owner_lookup(
+    db: AsyncSession,
+    *,
+    setup_data: StudySetupConfigData,
+    result: SetupProjectionResult,
+) -> dict[str, uuid.UUID]:
+    owners: set[str] = set()
+    for row in setup_data.projectMilestones:
+        owner = _normalize_text(row.owner)
+        if owner:
+            owners.add(owner)
+    for row in setup_data.siteMilestones:
+        owner = _normalize_text(row.owner)
+        if owner:
+            owners.add(owner)
+
+    if not owners:
+        return {}
+
+    users_result = await db.execute(
+        select(User.id, User.full_name, User.email).where(
+            or_(User.full_name.in_(owners), User.email.in_(owners))
+        )
+    )
+    rows = users_result.all()
+
+    owner_candidates: dict[str, set[uuid.UUID]] = {}
+    for user_id, full_name, email in rows:
+        full_name_key = _normalize_text(full_name)
+        email_key = _normalize_text(email)
+        if full_name_key and full_name_key in owners:
+            owner_candidates.setdefault(full_name_key, set()).add(user_id)
+        if email_key and email_key in owners:
+            owner_candidates.setdefault(email_key, set()).add(user_id)
+
+    resolved: dict[str, uuid.UUID] = {}
+    for owner in sorted(owners):
+        candidates = owner_candidates.get(owner, set())
+        if len(candidates) == 1:
+            resolved[owner] = next(iter(candidates))
+        elif len(candidates) > 1:
+            result.warnings.append(f"milestone_owner_ambiguous:{owner}")
+    return resolved
+
+
+async def _replace_project_milestones(
+    db: AsyncSession,
+    *,
+    study_id: uuid.UUID,
+    setup_data: StudySetupConfigData,
+    owner_lookup: dict[str, uuid.UUID],
+    result: SetupProjectionResult,
+) -> None:
+    await db.execute(
+        delete(Milestone).where(
+            Milestone.study_id == study_id,
+            Milestone.type == PROJECT_MILESTONE_TYPE,
+        )
+    )
+    for row in setup_data.projectMilestones:
+        if not any([(row.name or "").strip(), (row.owner or "").strip(), (row.remark or "").strip(), (row.planDate or "").strip()]):
+            continue
+        name = (row.name or "").strip()
+        if not name:
+            result.warnings.append(f"project_milestone_name_empty:{row.id}")
+            continue
+        planned_date = _parse_date(row.planDate)
+        if row.planDate and not planned_date:
+            result.warnings.append(f"project_milestone_plan_date_invalid:{row.id}")
+        raw_status = (row.status or "").strip()
+        mapped_status = MILESTONE_STATUS_MAP.get(raw_status, "NOT_STARTED")
+        if raw_status and raw_status not in MILESTONE_STATUS_MAP:
+            result.warnings.append(f"project_milestone_status_unknown:{row.id}")
+        owner_name = _normalize_text(row.owner)
+        owner_id = owner_lookup.get(owner_name, None) if owner_name else None
+        db.add(
+            Milestone(
+                study_id=study_id,
+                type=PROJECT_MILESTONE_TYPE,
+                name=name,
+                planned_date=planned_date,
+                status=mapped_status,
+                owner_id=owner_id,
+                owner_name=owner_name,
+                notes=_normalize_text(row.remark),
+            )
+        )
+
+
+async def _replace_site_milestones(
+    db: AsyncSession,
+    *,
+    study_id: uuid.UUID,
+    setup_data: StudySetupConfigData,
+    owner_lookup: dict[str, uuid.UUID],
+    result: SetupProjectionResult,
+) -> None:
+    await db.execute(
+        delete(Milestone).where(
+            Milestone.study_id == study_id,
+            Milestone.type == SITE_MILESTONE_TYPE,
+        )
+    )
+    for row in setup_data.siteMilestones:
+        if not any(
+            [
+                (row.milestone or "").strip(),
+                (row.owner or "").strip(),
+                (row.remark or "").strip(),
+                (row.planDate or "").strip(),
+            ]
+        ):
+            continue
+        milestone_name = (row.milestone or "").strip()
+        if not milestone_name:
+            result.warnings.append(f"site_milestone_name_empty:{row.id}")
+            continue
+        planned_date = _parse_date(row.planDate)
+        if row.planDate and not planned_date:
+            result.warnings.append(f"site_milestone_plan_date_invalid:{row.id}")
+        mapped_status = _map_milestone_status(row.status)
+        if mapped_status is None:
+            result.warnings.append(f"site_milestone_status_unknown:{row.id}")
+            mapped_status = "NOT_STARTED"
+        owner_name = _normalize_text(row.owner)
+        owner_id = owner_lookup.get(owner_name, None) if owner_name else None
+        db.add(
+            Milestone(
+                study_id=study_id,
+                type=SITE_MILESTONE_TYPE,
+                name=milestone_name,
+                planned_date=planned_date,
+                status=mapped_status,
+                owner_id=owner_id,
+                owner_name=owner_name,
+                notes=_normalize_text(row.remark),
+            )
+        )
+
+
+async def _replace_monitoring_strategies(
+    db: AsyncSession,
+    *,
+    study_id: uuid.UUID,
+    setup_data: StudySetupConfigData,
+    result: SetupProjectionResult,
+) -> None:
+    await db.execute(delete(StudyMonitoringStrategy).where(StudyMonitoringStrategy.study_id == study_id))
+    for row in setup_data.monitoringStrategies:
+        strategy_type = _normalize_text(row.strategyType)
+        detail = _normalize_text(row.detail)
+        frequency = _normalize_text(row.frequency)
+        if not any([strategy_type, detail, frequency]):
+            continue
+        if not strategy_type or not detail or not frequency:
+            result.warnings.append(f"monitoring_strategy_incomplete:{row.id}")
+            continue
+        db.add(
+            StudyMonitoringStrategy(
+                study_id=study_id,
+                source_setup_item_id=_normalize_text(row.id),
+                strategy_type=strategy_type,
+                detail=detail,
+                frequency=frequency,
+                enabled=bool(row.enabled),
+            )
+        )
+
+
+async def _replace_center_confirms(
+    db: AsyncSession,
+    *,
+    study_id: uuid.UUID,
+    setup_data: StudySetupConfigData,
+    site_map: dict[str, Site],
+    result: SetupProjectionResult,
+) -> None:
+    await db.execute(delete(StudyCenterConfirm).where(StudyCenterConfirm.study_id == study_id))
+    for row in setup_data.centerConfirm:
+        site_id = (row.siteId or "").strip()
+        confirmer = _normalize_text(row.confirmer)
+        note = _normalize_text(row.note)
+        raw_confirm_date = row.confirmDate or ""
+        parsed_confirm_date = _parse_date(raw_confirm_date)
+        if not any([site_id, confirmer, note, raw_confirm_date]):
+            continue
+        if not site_id:
+            result.skipped_items.append(SetupProjectionSkippedItem(site_id="", reason="center_confirm_site_id_empty"))
+            continue
+        site = site_map.get(site_id)
+        if not site:
+            result.skipped_items.append(SetupProjectionSkippedItem(site_id=site_id, reason="center_confirm_site_not_found"))
+            continue
+        if not site.is_active:
+            result.skipped_items.append(SetupProjectionSkippedItem(site_id=site_id, reason="center_confirm_site_inactive"))
+            continue
+        if raw_confirm_date and not parsed_confirm_date:
+            result.skipped_items.append(SetupProjectionSkippedItem(site_id=site_id, reason="center_confirm_date_invalid"))
+            result.warnings.append(f"center_confirm_date_invalid:{site_id}")
+            continue
+        db.add(
+            StudyCenterConfirm(
+                study_id=study_id,
+                site_id=site.id,
+                source_setup_item_id=_normalize_text(row.id),
+                confirmer=confirmer,
+                confirm_status=_normalize_text(row.confirmStatus) or "待确认",
+                confirm_date=parsed_confirm_date,
+                note=note,
+            )
+        )
+
+
+async def apply_setup_projection_on_publish(
+    db: AsyncSession,
+    *,
+    study_id: uuid.UUID,
+    setup_data: StudySetupConfigData,
+    operator_id: uuid.UUID | None,
+) -> SetupProjectionResult:
+    _ = operator_id
+    result = SetupProjectionResult(status="success")
+
+    study_result = await db.execute(select(Study).where(Study.id == study_id))
+    study = study_result.scalar_one_or_none()
+    if not study:
+        return SetupProjectionResult(
+            status="failed",
+            warnings=["study_not_found"],
+            site_skipped_count=0,
+        )
+
+    if study.is_locked:
+        result.status = "partial_success"
+        result.warnings.append("study_locked_skipped")
+        result.skipped_items.append(SetupProjectionSkippedItem(site_id=str(study_id), reason="study_locked"))
+        result.site_skipped_count = 1
+        return result
+
+    plan = setup_data.enrollmentPlan
+    new_monthly_goal_note = _normalize_text(plan.monthlyGoalNote)
+    new_stage_breakdown = _normalize_text(plan.stageBreakdown)
+    study_changed = (
+        study.planned_enrollment_count != plan.totalTarget
+        or study.enrollment_monthly_goal_note != new_monthly_goal_note
+        or study.enrollment_stage_breakdown != new_stage_breakdown
+    )
+    study.planned_enrollment_count = plan.totalTarget
+    study.enrollment_monthly_goal_note = new_monthly_goal_note
+    study.enrollment_stage_breakdown = new_stage_breakdown
+    result.study_updated = study_changed
+
+    site_result = await db.execute(select(Site).where(Site.study_id == study_id))
+    site_map = {str(site.id): site for site in site_result.scalars().all()}
+
+    deduped_plans: dict[str, tuple[int, str, str, str]] = {}
+    duplicate_ids: set[str] = set()
+    for row in setup_data.siteEnrollmentPlans:
+        site_id = (row.siteId or "").strip()
+        if not site_id:
+            result.skipped_items.append(SetupProjectionSkippedItem(site_id="", reason="site_id_empty"))
+            continue
+        if site_id in deduped_plans:
+            duplicate_ids.add(site_id)
+        deduped_plans[site_id] = (
+            row.target,
+            row.startDate or "",
+            row.endDate or "",
+            row.note or "",
+        )
+
+    for site_id in sorted(duplicate_ids):
+        result.warnings.append(f"duplicate_site_enrollment_plan:{site_id}")
+
+    for site_id, (target, raw_start_date, raw_end_date, raw_note) in deduped_plans.items():
+        site = site_map.get(site_id)
+        if not site:
+            result.skipped_items.append(SetupProjectionSkippedItem(site_id=site_id, reason="site_not_found"))
+            continue
+        if not site.is_active:
+            result.skipped_items.append(SetupProjectionSkippedItem(site_id=site_id, reason="site_inactive"))
+            continue
+        if target < 0:
+            result.skipped_items.append(SetupProjectionSkippedItem(site_id=site_id, reason="target_invalid"))
+            result.warnings.append(f"target_invalid:{site_id}")
+            continue
+        start_date = _parse_date(raw_start_date)
+        end_date = _parse_date(raw_end_date)
+        if raw_start_date and not start_date:
+            result.skipped_items.append(SetupProjectionSkippedItem(site_id=site_id, reason="site_plan_start_date_invalid"))
+            result.warnings.append(f"site_plan_start_date_invalid:{site_id}")
+            continue
+        if raw_end_date and not end_date:
+            result.skipped_items.append(SetupProjectionSkippedItem(site_id=site_id, reason="site_plan_end_date_invalid"))
+            result.warnings.append(f"site_plan_end_date_invalid:{site_id}")
+            continue
+        site.enrollment_target = target
+        site.enrollment_plan_start_date = start_date
+        site.enrollment_plan_end_date = end_date
+        site.enrollment_plan_note = _normalize_text(raw_note)
+        result.site_updated_count += 1
+
+    owner_lookup = await _build_owner_lookup(db, setup_data=setup_data, result=result)
+    await _replace_project_milestones(
+        db,
+        study_id=study_id,
+        setup_data=setup_data,
+        owner_lookup=owner_lookup,
+        result=result,
+    )
+    await _replace_site_milestones(
+        db,
+        study_id=study_id,
+        setup_data=setup_data,
+        owner_lookup=owner_lookup,
+        result=result,
+    )
+    await _replace_monitoring_strategies(db, study_id=study_id, setup_data=setup_data, result=result)
+    await _replace_center_confirms(db, study_id=study_id, setup_data=setup_data, site_map=site_map, result=result)
+
+    result.site_skipped_count = len(result.skipped_items)
+    if result.site_skipped_count > 0 and result.status != "failed":
+        result.status = "partial_success"
+    return result

backend/requirements.txt

@@ -14,3 +14,4 @@ pytest-asyncio==0.23.5
 httpx==0.25.2
 email-validator==2.1.1
 alembic==1.13.1
+openpyxl==3.1.5

backend/scripts/smoke_setup_config.py

@@ -0,0 +1,481 @@
+import asyncio
+import json
+import os
+import sys
+import tempfile
+import urllib.error
+import urllib.request
+import uuid
+
+import asyncpg
+
+
+BASE = os.getenv("BASE_URL", "http://localhost:8000")
+ADMIN_EMAIL = os.getenv("EMAIL", "admin@example.com")
+ADMIN_PASSWORD = os.getenv("PASSWORD", "admin123")
+STUDY_ID = os.getenv("STUDY_ID", "").strip()
+DATABASE_URL = (os.getenv("DATABASE_URL") or "postgresql://ctms_user:secret_password@db/ctms_db").replace("+asyncpg", "")
+
+
+def request_json(path: str, *, method: str = "GET", token: str | None = None, payload: dict | None = None) -> tuple[int, dict]:
+    url = f"{BASE}{path}"
+    headers = {}
+    body = None
+    if token:
+        headers["Authorization"] = f"Bearer {token}"
+    if payload is not None:
+        headers["Content-Type"] = "application/json"
+        body = json.dumps(payload).encode()
+    req = urllib.request.Request(url, method=method, headers=headers, data=body)
+    try:
+        with urllib.request.urlopen(req, timeout=20) as resp:
+            text = resp.read().decode() or "{}"
+            return resp.getcode(), json.loads(text)
+    except urllib.error.HTTPError as exc:
+        text = exc.read().decode() or "{}"
+        try:
+            body_json = json.loads(text)
+        except Exception:
+            body_json = {"raw": text}
+        return exc.code, body_json
+
+
+def request_bytes(path: str, *, method: str = "GET", token: str | None = None) -> tuple[int, bytes]:
+    url = f"{BASE}{path}"
+    headers = {}
+    if token:
+        headers["Authorization"] = f"Bearer {token}"
+    req = urllib.request.Request(url, method=method, headers=headers)
+    try:
+        with urllib.request.urlopen(req, timeout=30) as resp:
+            return resp.getcode(), resp.read()
+    except urllib.error.HTTPError as exc:
+        return exc.code, exc.read()
+
+
+def request_multipart(
+    path: str,
+    *,
+    token: str,
+    file_field: str,
+    file_name: str,
+    file_content: bytes,
+    expected_version: int,
+) -> tuple[int, dict]:
+    boundary = f"----ctms-boundary-{uuid.uuid4().hex}"
+    chunks: list[bytes] = []
+    chunks.append(
+        (
+            f"--{boundary}\r\n"
+            f'Content-Disposition: form-data; name="expected_version"\r\n\r\n'
+            f"{expected_version}\r\n"
+        ).encode("utf-8")
+    )
+    chunks.append(
+        (
+            f"--{boundary}\r\n"
+            f'Content-Disposition: form-data; name="{file_field}"; filename="{file_name}"\r\n'
+            f"Content-Type: application/vnd.openxmlformats-officedocument.spreadsheetml.sheet\r\n\r\n"
+        ).encode("utf-8")
+    )
+    chunks.append(file_content)
+    chunks.append(b"\r\n")
+    chunks.append(f"--{boundary}--\r\n".encode("utf-8"))
+    body = b"".join(chunks)
+
+    url = f"{BASE}{path}"
+    headers = {
+        "Authorization": f"Bearer {token}",
+        "Content-Type": f"multipart/form-data; boundary={boundary}",
+    }
+    req = urllib.request.Request(url, method="POST", headers=headers, data=body)
+    try:
+        with urllib.request.urlopen(req, timeout=30) as resp:
+            text = resp.read().decode() or "{}"
+            return resp.getcode(), json.loads(text)
+    except urllib.error.HTTPError as exc:
+        text = exc.read().decode() or "{}"
+        try:
+            body_json = json.loads(text)
+        except Exception:
+            body_json = {"raw": text}
+        return exc.code, body_json
+
+
+def assert_or_exit(condition: bool, message: str) -> None:
+    if not condition:
+        print(f"[FAIL] {message}")
+        sys.exit(1)
+
+
+def extract_items(payload: dict) -> list[dict]:
+    if isinstance(payload, list):
+        return payload
+    items = payload.get("items")
+    if isinstance(items, list):
+        return items
+    return []
+
+
+async def _db_fetch(sql: str, *args):
+    conn = await asyncpg.connect(DATABASE_URL)
+    try:
+        rows = await conn.fetch(sql, *args)
+        return [dict(row) for row in rows]
+    finally:
+        await conn.close()
+
+
+def db_fetch(sql: str, *args) -> list[dict]:
+    return asyncio.run(_db_fetch(sql, *args))
+
+
+def main() -> int:
+    print(f"[config] BASE={BASE} EMAIL={ADMIN_EMAIL}")
+    status, login = request_json(
+        "/api/v1/auth/login",
+        method="POST",
+        payload={"email": ADMIN_EMAIL, "password": ADMIN_PASSWORD},
+    )
+    assert_or_exit(status == 200, f"登录失败 status={status} body={login}")
+    token = login["access_token"]
+
+    if STUDY_ID:
+        study_id = STUDY_ID
+    else:
+        status, studies = request_json("/api/v1/studies/?skip=0&limit=1", token=token)
+        assert_or_exit(status == 200, f"获取项目列表失败 status={status} body={studies}")
+        items = studies.get("items") or []
+        assert_or_exit(bool(items), "未找到可用项目，请设置环境变量 STUDY_ID")
+        study_id = items[0]["id"]
+    print(f"[1/12] study_id={study_id}")
+
+    status, study_before = request_json(f"/api/v1/studies/{study_id}", token=token)
+    assert_or_exit(status == 200, f"获取项目详情失败 status={status} body={study_before}")
+
+    status, sites_resp = request_json(f"/api/v1/studies/{study_id}/sites/?include_inactive=true&skip=0&limit=200", token=token)
+    assert_or_exit(status == 200, f"获取中心列表失败 status={status} body={sites_resp}")
+    sites = extract_items(sites_resp if isinstance(sites_resp, dict) else {"items": sites_resp})
+    active_sites = [item for item in sites if item.get("is_active") is True]
+    assert_or_exit(len(active_sites) >= 1, "至少需要1个活跃中心以验证中心目标联动")
+
+    status, cfg = request_json(f"/api/v1/studies/{study_id}/setup-config", token=token)
+    assert_or_exit(status == 200, f"获取配置失败 status={status} body={cfg}")
+    version = cfg["version"]
+    print(f"[2/12] get_ok version={version}")
+
+    payload = {"expected_version": version, "data": cfg["data"]}
+    payload["data"]["projectMilestones"] = [
+        {
+            "id": "smoke-project-ms-1",
+            "name": "立项启动",
+            "planDate": "2026-02-20",
+            "owner": ADMIN_EMAIL,
+            "remark": "project-ms-remark",
+            "status": "进行中",
+        }
+    ]
+    payload["data"]["enrollmentPlan"]["monthlyGoalNote"] = f"smoke-test-note-v{version}"
+    payload["data"]["enrollmentPlan"]["stageBreakdown"] = f"smoke-stage-v{version}"
+    payload["data"]["enrollmentPlan"]["totalTarget"] = max(1, int(study_before.get("planned_enrollment_count") or 0) + 7)
+    payload["data"]["enrollmentPlan"]["startDate"] = "2026-03-01"
+    payload["data"]["enrollmentPlan"]["endDate"] = "2026-09-30"
+    payload["data"]["siteMilestones"] = [
+        {
+            "id": "smoke-site-ms-1",
+            "siteId": active_sites[0]["id"],
+            "siteName": active_sites[0].get("name") or "",
+            "milestone": "中心启动",
+            "planDate": "2026-03-05",
+            "owner": ADMIN_EMAIL,
+            "remark": "site-ms-remark",
+        }
+    ]
+    payload["data"]["siteEnrollmentPlans"] = [
+        {
+            "id": f"smoke-plan-{idx+1}",
+            "siteId": site["id"],
+            "siteName": site.get("name") or "",
+            "target": 10 if idx == 0 else 8,
+            "startDate": "2026-03-01",
+            "endDate": "2026-09-30",
+            "note": "smoke-site-plan",
+        }
+        for idx, site in enumerate(active_sites[:2])
+    ]
+    payload["data"]["monitoringStrategies"] = [
+        {
+            "id": "smoke-monitoring-1",
+            "strategyType": "风险监查",
+            "detail": "基于关键风险触发",
+            "frequency": "按触发",
+            "updatedAt": "",
+            "enabled": True,
+        }
+    ]
+    payload["data"]["centerConfirm"] = [
+        {
+            "id": "smoke-center-confirm-1",
+            "siteId": active_sites[0]["id"],
+            "siteName": active_sites[0].get("name") or "",
+            "confirmer": "System Admin",
+            "confirmStatus": "已确认",
+            "confirmDate": "2026-03-15",
+            "note": "smoke-center-confirm",
+        }
+    ]
+
+    targeted_site_ids = {item["siteId"] for item in payload["data"]["siteEnrollmentPlans"]}
+    before_site_map = {str(item.get("id")): item for item in sites if str(item.get("id")) in targeted_site_ids}
+
+    status, updated = request_json(f"/api/v1/studies/{study_id}/setup-config", token=token, method="PUT", payload=payload)
+    assert_or_exit(status == 200, f"保存草稿失败 status={status} body={updated}")
+    latest_version = updated["version"]
+    print(f"[3/12] put_ok version={latest_version}")
+
+    status, study_after_save = request_json(f"/api/v1/studies/{study_id}", token=token)
+    assert_or_exit(status == 200, f"保存后获取项目详情失败 status={status} body={study_after_save}")
+    assert_or_exit(
+        study_after_save.get("planned_enrollment_count") == study_before.get("planned_enrollment_count")
+        and study_after_save.get("plan_start_date") == study_before.get("plan_start_date")
+        and study_after_save.get("plan_end_date") == study_before.get("plan_end_date")
+        and study_after_save.get("enrollment_monthly_goal_note") == study_before.get("enrollment_monthly_goal_note")
+        and study_after_save.get("enrollment_stage_breakdown") == study_before.get("enrollment_stage_breakdown"),
+        "保存草稿不应写入项目业务表字段",
+    )
+
+    status, sites_after_save_resp = request_json(
+        f"/api/v1/studies/{study_id}/sites/?include_inactive=true&skip=0&limit=200", token=token
+    )
+    assert_or_exit(status == 200, f"保存后获取中心失败 status={status} body={sites_after_save_resp}")
+    sites_after_save = extract_items(sites_after_save_resp if isinstance(sites_after_save_resp, dict) else {"items": sites_after_save_resp})
+    after_save_site_map = {str(item.get("id")): item for item in sites_after_save if str(item.get("id")) in targeted_site_ids}
+    for site_id in targeted_site_ids:
+        before_item = before_site_map.get(site_id)
+        after_item = after_save_site_map.get(site_id)
+        if not before_item or not after_item:
+            continue
+        assert_or_exit(
+            after_item.get("enrollment_target") == before_item.get("enrollment_target")
+            and after_item.get("enrollment_plan_start_date") == before_item.get("enrollment_plan_start_date")
+            and after_item.get("enrollment_plan_end_date") == before_item.get("enrollment_plan_end_date")
+            and after_item.get("enrollment_plan_note") == before_item.get("enrollment_plan_note"),
+            f"保存草稿不应写入中心业务表字段 site={site_id}",
+        )
+    print("[4/12] save_no_projection_ok")
+
+    status, stale_result = request_json(
+        f"/api/v1/studies/{study_id}/setup-config",
+        token=token,
+        method="PUT",
+        payload={"expected_version": version, "data": updated["data"]},
+    )
+    stale_code = (stale_result.get("detail") or {}).get("code") if isinstance(stale_result.get("detail"), dict) else ""
+    assert_or_exit(status == 409 and stale_code == "SETUP_CONFIG_VERSION_CONFLICT", f"冲突校验失败 status={status} body={stale_result}")
+    print("[5/12] conflict_409_ok")
+
+    invalid_payload = json.loads(json.dumps(updated))
+    invalid_payload["expected_version"] = latest_version
+    invalid_payload["data"]["enrollmentPlan"]["startDate"] = "2026-12-31"
+    invalid_payload["data"]["enrollmentPlan"]["endDate"] = "2026-01-01"
+    status, invalid_result = request_json(
+        f"/api/v1/studies/{study_id}/setup-config",
+        token=token,
+        method="PUT",
+        payload={"expected_version": invalid_payload["expected_version"], "data": invalid_payload["data"]},
+    )
+    detail = invalid_result.get("detail") if isinstance(invalid_result, dict) else None
+    err_code = detail.get("code") if isinstance(detail, dict) else ""
+    err_list = detail.get("errors") if isinstance(detail, dict) else []
+    has_enrollment_date_error = any((item.get("field") == "enrollmentPlan.endDate") for item in (err_list or []))
+    assert_or_exit(status == 422 and err_code == "VALIDATION_ERROR" and has_enrollment_date_error, f"422校验失败 status={status} body={invalid_result}")
+    print("[6/12] validation_422_ok")
+
+    status, published = request_json(
+        f"/api/v1/studies/{study_id}/setup-config/publish",
+        token=token,
+        method="POST",
+        payload={"expected_version": latest_version},
+    )
+    assert_or_exit(status == 200 and published.get("publish_status") == "PUBLISHED", f"发布失败 status={status} body={published}")
+    projection_status = str(published.get("projection_status") or "").lower()
+    assert_or_exit(
+        projection_status in {"success", "partial_success"},
+        f"发布联动状态异常 projection_status={published.get('projection_status')} body={published}",
+    )
+    first_published_version = published["version"]
+    print(f"[7/12] first_publish_ok version={first_published_version}")
+
+    status, study_detail = request_json(f"/api/v1/studies/{study_id}", token=token)
+    assert_or_exit(status == 200, f"获取项目详情失败 status={status} body={study_detail}")
+    assert_or_exit(
+        study_detail.get("planned_enrollment_count") == payload["data"]["enrollmentPlan"]["totalTarget"],
+        f"项目计划入组联动失败 expected={payload['data']['enrollmentPlan']['totalTarget']} actual={study_detail.get('planned_enrollment_count')}",
+    )
+    assert_or_exit(
+        study_detail.get("plan_start_date") == payload["data"]["enrollmentPlan"]["startDate"]
+        and study_detail.get("plan_end_date") == payload["data"]["enrollmentPlan"]["endDate"],
+        f"项目计划日期联动失败 expected=({payload['data']['enrollmentPlan']['startDate']},{payload['data']['enrollmentPlan']['endDate']}) actual=({study_detail.get('plan_start_date')},{study_detail.get('plan_end_date')})",
+    )
+    assert_or_exit(
+        study_detail.get("enrollment_monthly_goal_note") == payload["data"]["enrollmentPlan"]["monthlyGoalNote"]
+        and study_detail.get("enrollment_stage_breakdown") == payload["data"]["enrollmentPlan"]["stageBreakdown"],
+        "项目入组补充说明联动失败",
+    )
+
+    status, sites_after_resp = request_json(f"/api/v1/studies/{study_id}/sites/?include_inactive=true&skip=0&limit=200", token=token)
+    assert_or_exit(status == 200, f"发布后获取中心失败 status={status} body={sites_after_resp}")
+    sites_after = extract_items(sites_after_resp if isinstance(sites_after_resp, dict) else {"items": sites_after_resp})
+    site_target_map = {str(item.get("id")): item.get("enrollment_target") for item in sites_after}
+    site_plan_start_map = {str(item.get("id")): item.get("enrollment_plan_start_date") for item in sites_after}
+    site_plan_end_map = {str(item.get("id")): item.get("enrollment_plan_end_date") for item in sites_after}
+    site_plan_note_map = {str(item.get("id")): item.get("enrollment_plan_note") for item in sites_after}
+    for plan in payload["data"]["siteEnrollmentPlans"]:
+        actual_target = site_target_map.get(str(plan["siteId"]))
+        assert_or_exit(
+            actual_target == plan["target"],
+            f"中心目标联动失败 site={plan['siteId']} expected={plan['target']} actual={actual_target}",
+        )
+        assert_or_exit(
+            site_plan_start_map.get(str(plan["siteId"])) == plan["startDate"]
+            and site_plan_end_map.get(str(plan["siteId"])) == plan["endDate"]
+            and site_plan_note_map.get(str(plan["siteId"])) == plan["note"],
+            f"中心入组计划附加字段联动失败 site={plan['siteId']}",
+        )
+
+    monitoring_rows = db_fetch(
+        """
+        SELECT strategy_type, detail, frequency, enabled
+        FROM study_monitoring_strategies
+        WHERE study_id = $1::uuid
+        """,
+        study_id,
+    )
+    assert_or_exit(len(monitoring_rows) == 1, f"监查策略联动失败 rows={monitoring_rows}")
+    assert_or_exit(
+        monitoring_rows[0]["strategy_type"] == "风险监查"
+        and monitoring_rows[0]["detail"] == "基于关键风险触发"
+        and monitoring_rows[0]["frequency"] == "按触发"
+        and monitoring_rows[0]["enabled"] is True,
+        f"监查策略字段联动失败 rows={monitoring_rows}",
+    )
+
+    center_confirm_rows = db_fetch(
+        """
+        SELECT site_id::text AS site_id, confirmer, confirm_status, confirm_date::text AS confirm_date, note
+        FROM study_center_confirms
+        WHERE study_id = $1::uuid
+        """,
+        study_id,
+    )
+    assert_or_exit(len(center_confirm_rows) == 1, f"中心确认联动失败 rows={center_confirm_rows}")
+    assert_or_exit(
+        center_confirm_rows[0]["site_id"] == active_sites[0]["id"]
+        and center_confirm_rows[0]["confirm_status"] == "已确认"
+        and center_confirm_rows[0]["confirm_date"] == "2026-03-15"
+        and center_confirm_rows[0]["note"] == "smoke-center-confirm",
+        f"中心确认字段联动失败 rows={center_confirm_rows}",
+    )
+
+    milestone_rows = db_fetch(
+        """
+        SELECT type, name, owner_id::text AS owner_id, owner_name, notes
+        FROM milestones
+        WHERE study_id = $1::uuid
+          AND type IN ('SETUP_PROJECT_MILESTONE', 'SETUP_SITE_MILESTONE')
+        ORDER BY type, name
+        """,
+        study_id,
+    )
+    milestone_map = {(row["type"], row["name"]): row for row in milestone_rows}
+    project_row = milestone_map.get(("SETUP_PROJECT_MILESTONE", "立项启动"))
+    site_row = milestone_map.get(("SETUP_SITE_MILESTONE", "中心启动"))
+    assert_or_exit(project_row is not None and site_row is not None, f"里程碑联动失败 rows={milestone_rows}")
+    assert_or_exit(
+        project_row.get("owner_name") == ADMIN_EMAIL
+        and bool(project_row.get("owner_id"))
+        and project_row.get("notes") == "project-ms-remark",
+        f"项目里程碑owner结构化失败 row={project_row}",
+    )
+    assert_or_exit(
+        site_row.get("owner_name") == ADMIN_EMAIL
+        and bool(site_row.get("owner_id"))
+        and site_row.get("notes") == "site-ms-remark",
+        f"中心里程碑owner结构化失败 row={site_row}",
+    )
+    print("[8/12] publish_projection_db_assert_ok")
+
+    payload_v2 = {"expected_version": published["version"], "data": published["data"]}
+    payload_v2["data"]["enrollmentPlan"]["totalTarget"] = payload["data"]["enrollmentPlan"]["totalTarget"] + 3
+    payload_v2["data"]["enrollmentPlan"]["monthlyGoalNote"] = payload["data"]["enrollmentPlan"]["monthlyGoalNote"] + "-v2"
+    if payload_v2["data"]["siteEnrollmentPlans"]:
+        payload_v2["data"]["siteEnrollmentPlans"][0]["target"] = payload_v2["data"]["siteEnrollmentPlans"][0]["target"] + 2
+
+    status, updated_v2 = request_json(
+        f"/api/v1/studies/{study_id}/setup-config",
+        token=token,
+        method="PUT",
+        payload=payload_v2,
+    )
+    assert_or_exit(status == 200, f"二次保存草稿失败 status={status} body={updated_v2}")
+    status, published_v2 = request_json(
+        f"/api/v1/studies/{study_id}/setup-config/publish",
+        token=token,
+        method="POST",
+        payload={"expected_version": updated_v2["version"]},
+    )
+    assert_or_exit(status == 200 and published_v2.get("publish_status") == "PUBLISHED", f"二次发布失败 status={status} body={published_v2}")
+
+    status, rolled = request_json(
+        f"/api/v1/studies/{study_id}/setup-config/rollback",
+        token=token,
+        method="POST",
+        payload={"expected_version": published_v2["version"], "target_version": first_published_version},
+    )
+    assert_or_exit(status == 200, f"回滚失败 status={status} body={rolled}")
+    assert_or_exit(
+        rolled.get("publish_status") == "DRAFT"
+        and (rolled.get("data") or {}).get("enrollmentPlan", {}).get("totalTarget") == payload["data"]["enrollmentPlan"]["totalTarget"],
+        f"回滚结果异常 body={rolled}",
+    )
+    print("[9/12] rollback_ok")
+
+    status, exported_bytes = request_bytes(f"/api/v1/studies/{study_id}/setup-config/export-excel", token=token)
+    assert_or_exit(status == 200 and len(exported_bytes) > 0, f"导出Excel失败 status={status} bytes={len(exported_bytes)}")
+    with tempfile.NamedTemporaryFile(suffix=".xlsx", delete=False) as tmp:
+        tmp.write(exported_bytes)
+        tmp_path = tmp.name
+    print(f"[10/12] export_excel_ok file={tmp_path}")
+
+    status, imported = request_multipart(
+        f"/api/v1/studies/{study_id}/setup-config/import-excel",
+        token=token,
+        file_field="file",
+        file_name="setup-config-smoke.xlsx",
+        file_content=exported_bytes,
+        expected_version=rolled["version"],
+    )
+    assert_or_exit(status == 200 and isinstance(imported.get("version"), int), f"导入失败 status={status} body={imported}")
+    print(f"[11/12] import_excel_ok version={imported['version']}")
+
+    status, _ = request_json(f"/api/v1/studies/{study_id}/lock", token=token, method="PATCH", payload={})
+    assert_or_exit(status == 200, f"锁定失败 status={status}")
+    try:
+        status, locked_result = request_json(
+            f"/api/v1/studies/{study_id}/setup-config",
+            token=token,
+            method="PUT",
+            payload={"expected_version": imported["version"], "data": imported["data"]},
+        )
+        assert_or_exit(status == 403, f"锁定后写入应403，实际 status={status} body={locked_result}")
+        print("[12/12] lock_403_check_ok")
+    finally:
+        unlock_status, unlock_body = request_json(f"/api/v1/studies/{study_id}/unlock", token=token, method="PATCH", payload={})
+        assert_or_exit(unlock_status == 200, f"解锁失败 status={unlock_status} body={unlock_body}")
+
+    print("setup-config smoke test passed")
+    return 0
+
+
+if __name__ == "__main__":
+    sys.exit(main())

database/init.sql

@@ -163,6 +163,8 @@ CREATE TABLE IF NOT EXISTS public.adverse_events (
     action_taken text,
     outcome character varying(50),
     reported_to_sponsor boolean NOT NULL DEFAULT false,
+    is_sae boolean NOT NULL DEFAULT false,
+    is_susar boolean NOT NULL DEFAULT false,
     report_due_date date,
     status character varying(20) NOT NULL DEFAULT 'NEW',
     description text,

docker-compose.yaml

@@ -104,6 +104,7 @@ services:
     volumes:
       - ./nginx/nginx.conf:/etc/nginx/nginx.conf:ro
       - ./nginx/certs:/etc/nginx/certs:ro
+      - ./frontend/public/favicon.ico:/usr/share/nginx/html/favicon.ico:ro
     depends_on:
       - backend
       - frontend

docs/postman/local.postman_environment.json

@@ -0,0 +1,24 @@
+{
+  "id": "9f9bb57a-6de8-4e31-a7a4-e0c0e7c0d119",
+  "name": "CTMS Local",
+  "values": [
+    { "key": "base_url", "value": "http://localhost", "type": "default", "enabled": true },
+    { "key": "email", "value": "admin@example.com", "type": "default", "enabled": true },
+    { "key": "password", "value": "admin123", "type": "secret", "enabled": true },
+    { "key": "study_id", "value": "aaaaaaaa-aaaa-aaaa-aaaa-aaaaaaaaaaaa", "type": "default", "enabled": true },
+    { "key": "token", "value": "", "type": "default", "enabled": true },
+    { "key": "setup_version", "value": "1", "type": "default", "enabled": true },
+    { "key": "target_total", "value": "123", "type": "default", "enabled": true },
+    { "key": "plan_start_date", "value": "2026-02-01", "type": "default", "enabled": true },
+    { "key": "plan_end_date", "value": "2026-12-31", "type": "default", "enabled": true },
+    {
+      "key": "exported_data",
+      "value": "{\"projectMilestones\":[],\"enrollmentPlan\":{\"totalTarget\":0,\"startDate\":\"\",\"endDate\":\"\",\"monthlyGoalNote\":\"\",\"stageBreakdown\":\"\"},\"siteMilestones\":[],\"siteEnrollmentPlans\":[],\"monitoringStrategies\":[],\"centerConfirm\":[]}",
+      "type": "default",
+      "enabled": true
+    }
+  ],
+  "_postman_variable_scope": "environment",
+  "_postman_exported_at": "2026-02-09T00:00:00.000Z",
+  "_postman_exported_using": "Codex"
+}

docs/postman/setup-config.postman_collection.json

@@ -0,0 +1,203 @@
+{
+  "info": {
+    "name": "CTMS Setup Config API (Excel)",
+    "description": "立项配置接口联调集合（登录 -> 获取 -> 保存 -> 发布 -> 导出Excel -> 导入Excel）",
+    "schema": "https://schema.getpostman.com/json/collection/v2.1.0/collection.json"
+  },
+  "item": [
+    {
+      "name": "1. 登录（获取 Token）",
+      "request": {
+        "method": "POST",
+        "header": [
+          { "key": "Content-Type", "value": "application/json" }
+        ],
+        "body": {
+          "mode": "raw",
+          "raw": "{\n  \"email\": \"{{email}}\",\n  \"password\": \"{{password}}\"\n}"
+        },
+        "url": {
+          "raw": "{{base_url}}/api/v1/auth/login",
+          "host": ["{{base_url}}"],
+          "path": ["api", "v1", "auth", "login"]
+        }
+      },
+      "event": [
+        {
+          "listen": "test",
+          "script": {
+            "type": "text/javascript",
+            "exec": [
+              "pm.test('status is 200', function () { pm.response.to.have.status(200); });",
+              "var json = pm.response.json();",
+              "pm.collectionVariables.set('token', json.access_token || '');"
+            ]
+          }
+        }
+      ]
+    },
+    {
+      "name": "2. 获取立项配置",
+      "request": {
+        "method": "GET",
+        "header": [
+          { "key": "Authorization", "value": "Bearer {{token}}" }
+        ],
+        "url": {
+          "raw": "{{base_url}}/api/v1/studies/{{study_id}}/setup-config",
+          "host": ["{{base_url}}"],
+          "path": ["api", "v1", "studies", "{{study_id}}", "setup-config"]
+        }
+      },
+      "event": [
+        {
+          "listen": "test",
+          "script": {
+            "type": "text/javascript",
+            "exec": [
+              "pm.test('status is 200', function () { pm.response.to.have.status(200); });",
+              "var json = pm.response.json();",
+              "pm.collectionVariables.set('setup_version', String(json.version || 1));"
+            ]
+          }
+        }
+      ]
+    },
+    {
+      "name": "3. 保存草稿",
+      "request": {
+        "method": "PUT",
+        "header": [
+          { "key": "Authorization", "value": "Bearer {{token}}" },
+          { "key": "Content-Type", "value": "application/json" }
+        ],
+        "body": {
+          "mode": "raw",
+          "raw": "{\n  \"expected_version\": {{setup_version}},\n  \"data\": {\n    \"projectMilestones\": [],\n    \"enrollmentPlan\": {\n      \"totalTarget\": {{target_total}},\n      \"startDate\": \"{{plan_start_date}}\",\n      \"endDate\": \"{{plan_end_date}}\",\n      \"monthlyGoalNote\": \"Postman save draft\",\n      \"stageBreakdown\": \"phase-1\"\n    },\n    \"siteMilestones\": [],\n    \"siteEnrollmentPlans\": [],\n    \"monitoringStrategies\": [],\n    \"centerConfirm\": []\n  }\n}"
+        },
+        "url": {
+          "raw": "{{base_url}}/api/v1/studies/{{study_id}}/setup-config",
+          "host": ["{{base_url}}"],
+          "path": ["api", "v1", "studies", "{{study_id}}", "setup-config"]
+        }
+      },
+      "event": [
+        {
+          "listen": "test",
+          "script": {
+            "type": "text/javascript",
+            "exec": [
+              "pm.test('status is 200', function () { pm.response.to.have.status(200); });",
+              "var json = pm.response.json();",
+              "pm.collectionVariables.set('setup_version', String(json.version || pm.collectionVariables.get('setup_version') || '1'));"
+            ]
+          }
+        }
+      ]
+    },
+    {
+      "name": "4. 发布配置",
+      "request": {
+        "method": "POST",
+        "header": [
+          { "key": "Authorization", "value": "Bearer {{token}}" },
+          { "key": "Content-Type", "value": "application/json" }
+        ],
+        "body": {
+          "mode": "raw",
+          "raw": "{\n  \"expected_version\": {{setup_version}}\n}"
+        },
+        "url": {
+          "raw": "{{base_url}}/api/v1/studies/{{study_id}}/setup-config/publish",
+          "host": ["{{base_url}}"],
+          "path": ["api", "v1", "studies", "{{study_id}}", "setup-config", "publish"]
+        }
+      },
+      "event": [
+        {
+          "listen": "test",
+          "script": {
+            "type": "text/javascript",
+            "exec": [
+              "pm.test('status is 200', function () { pm.response.to.have.status(200); });",
+              "var json = pm.response.json();",
+              "pm.test('publish status is PUBLISHED', function () { pm.expect(json.publish_status).to.eql('PUBLISHED'); });",
+              "pm.collectionVariables.set('setup_version', String(json.version || pm.collectionVariables.get('setup_version') || '1'));"
+            ]
+          }
+        }
+      ]
+    },
+    {
+      "name": "5. 导出配置 Excel",
+      "request": {
+        "method": "GET",
+        "header": [
+          { "key": "Authorization", "value": "Bearer {{token}}" }
+        ],
+        "url": {
+          "raw": "{{base_url}}/api/v1/studies/{{study_id}}/setup-config/export-excel",
+          "host": ["{{base_url}}"],
+          "path": ["api", "v1", "studies", "{{study_id}}", "setup-config", "export-excel"]
+        }
+      },
+      "event": [
+        {
+          "listen": "test",
+          "script": {
+            "type": "text/javascript",
+            "exec": [
+              "pm.test('status is 200', function () { pm.response.to.have.status(200); });"
+            ]
+          }
+        }
+      ]
+    },
+    {
+      "name": "6. 导入配置 Excel",
+      "request": {
+        "method": "POST",
+        "header": [
+          { "key": "Authorization", "value": "Bearer {{token}}" }
+        ],
+        "body": {
+          "mode": "formdata",
+          "formdata": [
+            { "key": "expected_version", "value": "{{setup_version}}", "type": "text" },
+            { "key": "file", "type": "file", "src": "{{excel_file_path}}" }
+          ]
+        },
+        "url": {
+          "raw": "{{base_url}}/api/v1/studies/{{study_id}}/setup-config/import-excel",
+          "host": ["{{base_url}}"],
+          "path": ["api", "v1", "studies", "{{study_id}}", "setup-config", "import-excel"]
+        }
+      },
+      "event": [
+        {
+          "listen": "test",
+          "script": {
+            "type": "text/javascript",
+            "exec": [
+              "pm.test('status is 200', function () { pm.response.to.have.status(200); });",
+              "var json = pm.response.json();",
+              "pm.collectionVariables.set('setup_version', String(json.version || pm.collectionVariables.get('setup_version') || '1'));"
+            ]
+          }
+        }
+      ]
+    }
+  ],
+  "variable": [
+    { "key": "base_url", "value": "http://localhost" },
+    { "key": "email", "value": "admin@example.com" },
+    { "key": "password", "value": "admin123" },
+    { "key": "study_id", "value": "aaaaaaaa-aaaa-aaaa-aaaa-aaaaaaaaaaaa" },
+    { "key": "token", "value": "" },
+    { "key": "setup_version", "value": "1" },
+    { "key": "target_total", "value": "123" },
+    { "key": "plan_start_date", "value": "2026-02-01" },
+    { "key": "plan_end_date", "value": "2026-12-31" },
+    { "key": "excel_file_path", "value": "" }
+  ]
+}

docs/release-checklist.md

@@ -0,0 +1,64 @@
+# Release Checklist（立项配置）
+
+## 1. 构建与迁移
+- [ ] `cd backend && docker compose run --rm backend python -m alembic upgrade head`
+- [ ] `cd backend && python3 -m compileall app scripts`
+- [ ] `cd frontend && npm run build`
+
+## 2. 接口与权限回归
+- [ ] ADMIN 账号可 `GET/PUT/PUBLISH/IMPORT-EXCEL/EXPORT-EXCEL`
+- [ ] PM 账号可 `GET/PUT/PUBLISH/IMPORT-EXCEL/EXPORT-EXCEL`
+- [ ] CRA 账号可 `GET/EXPORT-EXCEL`，`PUT/PUBLISH/IMPORT-EXCEL` 返回 `403`
+- [ ] 非项目成员访问返回 `403`
+
+## 3. 并发冲突回归
+- [ ] 双开两个窗口同项目配置
+- [ ] A 保存后，B 再保存触发 `409`
+- [ ] 前端显示冲突对比弹窗（可读 diff + JSON）
+- [ ] 选择“使用服务器版本”后版本同步
+- [ ] 选择“用本地草稿覆盖”后保存成功且版本递增
+- [ ] `409` 响应结构包含 `detail.code=SETUP_CONFIG_VERSION_CONFLICT`
+
+## 3.1 业务校验回归（422）
+- [ ] `enrollmentPlan.startDate > endDate` 返回 `422`
+- [ ] 非本项目 `siteId` 返回 `422`
+- [ ] `centerConfirm` 状态为“已确认”但无 `confirmDate` 返回 `422`
+- [ ] `422` 响应包含 `detail.errors[].field` 与 `detail.errors[].message`
+
+## 4. 发布快照回归
+- [ ] 草稿保存后 `publish_status=DRAFT`
+- [ ] 发布后 `publish_status=PUBLISHED`
+- [ ] 发布后可切换“已发布快照”并只读
+- [ ] 再修改草稿后状态回到 `DRAFT`
+
+## 5. 导入导出回归
+- [ ] 导出 Excel 文件可打开且结构完整
+- [ ] 导入有效 Excel 成功，页面数据刷新
+- [ ] 导入非法 Excel 给出错误提示
+- [ ] 导入冲突时触发 `409` 提示并刷新版本
+
+## 6. 锁定与审计回归
+- [ ] 项目锁定后 `PUT/PUBLISH/IMPORT-EXCEL` 返回 `403`
+- [ ] 页面进入只读态，编辑按钮不可用
+- [ ] 审计日志可按对象类型筛选 `立项配置`
+- [ ] 审计事件包含:
+  - [ ] `CREATE_SETUP_CONFIG`
+  - [ ] `UPDATE_SETUP_CONFIG`
+  - [ ] `PUBLISH_SETUP_CONFIG`
+  - [ ] `IMPORT_SETUP_CONFIG_EXCEL`
+
+## 7. 监控埋点回归
+- [ ] 访问 `GET /health/setup-config-stats` 可返回 JSON
+- [ ] `by_endpoint` 中可看到 `setup-config` 各接口 `2xx/4xx/5xx` 计数
+- [ ] 人为制造一次冲突或锁定写入后，`4xx` 计数增加
+
+## 8. 冒烟脚本
+- [ ] `cd backend && docker compose exec -T backend python scripts/smoke_setup_config.py`
+- [ ] 使用 `BASE_URL/EMAIL/PASSWORD/STUDY_ID` 环境变量执行一次（覆盖指定项目）
+- [ ] `BASE_URL=http://localhost EMAIL=... PASSWORD=... STUDY_ID=... bash docs/setup-config-curl-smoke.sh`
+- [ ] 导入并执行 Postman 集合 `docs/postman/setup-config.postman_collection.json`
+
+## 9. 发布前确认
+- [ ] 文档已更新：`docs/setup-config-api.md`
+- [ ] 本清单已全量勾选
+- [ ] 发布说明已包含新增接口与权限规则

docs/setup-config-api.md

@@ -0,0 +1,180 @@
+# 立项配置接口说明（Excel 导入导出版）
+
+## 1. 概览
+- 基础路径: `/api/v1/studies/{study_id}/setup-config`
+- 数据作用域: 单项目唯一配置（`study_setup_configs.study_id` 唯一约束）
+- 存储格式: JSONB（字段结构与前端 `SetupConfigDraft` 对齐）
+- 并发控制: 乐观锁（`expected_version`）
+- 发布机制: 草稿/已发布（`publish_status`）
+- 前端视图语义:
+  - `草稿视图`: 当前草稿可编辑
+  - `发布预览`: 当前草稿只读预览（不直接读取 `published_data`）
+  - `published_data`: 用于发布快照、差异比较与版本能力
+
+## 2. 权限矩阵
+- `GET /setup-config`
+  - 允许: 项目成员、管理员
+- `PUT /setup-config`
+  - 允许: PM、ADMIN
+  - 限制: 项目锁定时返回 `403`
+- `POST /setup-config/publish`
+  - 允许: PM、ADMIN
+  - 限制: 项目锁定时返回 `403`
+- `GET /setup-config/export-excel`
+  - 允许: 项目成员、管理员
+- `POST /setup-config/import-excel`
+  - 允许: PM、ADMIN
+  - 限制: 项目锁定时返回 `403`
+
+## 3. 数据结构
+
+### 3.1 请求体（保存）
+```json
+{
+  "expected_version": 3,
+  "data": {
+    "projectMilestones": [
+      {
+        "id": "m1",
+        "name": "首例入组",
+        "planDate": "2026-03-01",
+        "owner": "项目经理",
+        "remark": "",
+        "status": "未开始"
+      }
+    ],
+    "enrollmentPlan": {
+      "totalTarget": 100,
+      "startDate": "2026-02-01",
+      "endDate": "2026-12-31",
+      "monthlyGoalNote": "按月拆解",
+      "stageBreakdown": "阶段1/2/3"
+    },
+    "siteMilestones": [],
+    "siteEnrollmentPlans": [],
+    "monitoringStrategies": [],
+    "centerConfirm": []
+  }
+}
+```
+
+### 3.2 响应体（GET/PUT/PUBLISH/IMPORT-EXCEL）
+```json
+{
+  "id": "f0ac2fca-5fd3-470e-8e7e-2ded2b8f0f77",
+  "study_id": "aaaaaaaa-aaaa-aaaa-aaaa-aaaaaaaaaaaa",
+  "version": 6,
+  "publish_status": "PUBLISHED",
+  "data": {
+    "projectMilestones": [],
+    "enrollmentPlan": {
+      "totalTarget": 120,
+      "startDate": "2026-02-01",
+      "endDate": "2026-12-31",
+      "monthlyGoalNote": "",
+      "stageBreakdown": ""
+    },
+    "siteMilestones": [],
+    "siteEnrollmentPlans": [],
+    "monitoringStrategies": [],
+    "centerConfirm": []
+  },
+  "published_data": null,
+  "saved_by": "11111111-1111-1111-1111-111111111111",
+  "saved_by_name": "System Admin",
+  "published_by": null,
+  "published_by_name": null,
+  "published_at": null,
+  "created_at": "2026-02-09T01:30:00.000000Z",
+  "updated_at": "2026-02-09T02:11:13.000000Z"
+}
+```
+
+## 4. 接口定义
+
+### 4.1 GET 获取配置
+```http
+GET /api/v1/studies/{study_id}/setup-config
+Authorization: Bearer <token>
+```
+
+### 4.2 PUT 保存配置（草稿）
+```http
+PUT /api/v1/studies/{study_id}/setup-config
+Authorization: Bearer <token>
+Content-Type: application/json
+```
+
+### 4.3 POST 发布配置
+```http
+POST /api/v1/studies/{study_id}/setup-config/publish
+Authorization: Bearer <token>
+Content-Type: application/json
+```
+
+### 4.4 GET 导出 Excel
+```http
+GET /api/v1/studies/{study_id}/setup-config/export-excel
+Authorization: Bearer <token>
+```
+说明:
+- 返回 `application/vnd.openxmlformats-officedocument.spreadsheetml.sheet`
+- 文件可直接作为导入模板继续回灌
+
+### 4.5 POST 导入 Excel
+```http
+POST /api/v1/studies/{study_id}/setup-config/import-excel
+Authorization: Bearer <token>
+Content-Type: multipart/form-data
+```
+表单字段:
+- `file`: `.xlsx` 文件（必填）
+- `expected_version`: 当前配置版本（可选，建议携带）
+
+说明:
+- 导入会覆盖当前草稿并自增版本。
+- 写入审计事件: `IMPORT_SETUP_CONFIG_EXCEL`。
+
+## 5. 错误码与典型场景
+- `400 BAD REQUEST`
+  - 上传文件非 `.xlsx`
+  - Excel 解析失败
+- `403 FORBIDDEN`
+  - 非 PM/ADMIN 导入/保存/发布
+  - 项目已锁定
+- `404 NOT FOUND`
+  - study 不存在
+- `409 CONFLICT`
+  - `expected_version` 与服务端不一致
+- `422 UNPROCESSABLE ENTITY`
+  - Excel 数据通过解析后，业务字段校验失败
+
+## 6. 联调脚本（curl）
+- 脚本路径: `docs/setup-config-curl-smoke.sh`
+- 使用方式:
+```bash
+chmod +x docs/setup-config-curl-smoke.sh
+BASE_URL=http://localhost \
+EMAIL=admin@example.com \
+PASSWORD=admin123 \
+STUDY_ID=aaaaaaaa-aaaa-aaaa-aaaa-aaaaaaaaaaaa \
+bash docs/setup-config-curl-smoke.sh
+```
+
+## 7. Postman 联调集合
+- Collection: `docs/postman/setup-config.postman_collection.json`
+- Environment: `docs/postman/local.postman_environment.json`
+
+## 8. 后端烟雾测试（非 pytest）
+```bash
+docker compose up -d db backend
+docker compose exec -T backend python scripts/smoke_setup_config.py
+```
+
+## 9. 监控埋点（4xx/5xx）
+- 中间件统计以下接口：
+  - `GET /api/v1/studies/{study_id}/setup-config`
+  - `PUT /api/v1/studies/{study_id}/setup-config`
+  - `POST /api/v1/studies/{study_id}/setup-config/publish`
+  - `GET /api/v1/studies/{study_id}/setup-config/export-excel`
+  - `POST /api/v1/studies/{study_id}/setup-config/import-excel`

docs/setup-config-code-audit.md

@@ -0,0 +1,74 @@
+# 立项配置代码审计报告（2026-02）
+
+## 范围
+- 前端：`frontend/src/views/admin/ProjectDetail.vue`、`frontend/src/api/studies.ts`、`frontend/src/types/setupConfig.ts`、`frontend/src/utils/setupFieldLocator.ts`
+- 后端：`backend/app/api/v1/studies.py`、`backend/app/crud/study_setup_config.py`、`backend/app/schemas/study_setup_config.py`、`backend/app/services/setup_config_excel.py`
+- 文档：`docs/setup-config-api.md`、`docs/setup-config-curl-smoke.sh`、`docs/postman/setup-config.postman_collection.json`、`backend/scripts/smoke_setup_config.py`
+
+## 发现清单
+
+### 严重（会导致错误或明显行为偏差）
+- 无新增严重问题。
+
+### 中等（会导致交互不一致或维护风险）
+1. `ProjectDetail.vue` 中存在大量 `v-if="false"` 历史分支（Step4-7），增加阅读成本并容易引发误改。
+2. 步骤表格从“输入态表格”转“展示态 + 抽屉编辑”后，存在未清理的旧方法与旧样式残留，导致逻辑路径复杂。
+3. “发布预览”语义已切换为“当前草稿只读预览”，但文档未明确，容易与后端 `published_data` 概念混淆。
+
+### 低（代码异味/重复/可读性）
+1. `ProjectDetail.vue` 文件过长（约 3800+ 行），后续改动冲突概率高。
+2. 多个步骤编辑抽屉逻辑重复，适合后续抽象为通用 `RowEditorDrawer`。
+3. 表格列模板重复，适合后续改为列配置驱动。
+
+## 本轮已处理
+1. 删除 Step4-7 全部 `v-if="false"` 模板分支。
+2. 删除上述分支遗留的无用方法：
+   - `handleSiteMilestoneSiteChange`
+   - `handleSiteEnrollmentSiteChange`
+   - `handleCenterConfirmSiteChange`
+   - `touchStrategy`
+   - `applyStrategy`
+3. 清理无用样式：
+   - `.section-toolbar`
+   - `.setup-content.is-published-preview .section-toolbar` 相关规则
+4. 保持现有交互行为不变并完成构建验证。
+5. 修复步骤标题行按钮保护不一致问题：
+   - 第2/4/5/6/7步标题行功能键增加 `:disabled="!canEditSetup"`，避免锁定项目或无权限时误触发。
+   - 对应新增/删除/抽屉打开与保存方法统一加守卫，防止外部调用绕过前端可见状态。
+6. 收敛重复的草稿可编辑判定，新增 `canMutateDraft()` 供步骤行编辑方法复用（不改变界面行为）。
+7. 抽取步骤行编辑通用控制器（`IndexedEditorController`）与通用函数：
+   - `openIndexedEditor`
+   - `getEditingIndex`
+   - `closeIndexedEditor`
+   复用到 Step2/4/5/6/7 的单行抽屉编辑逻辑，减少重复代码。
+8. 合并重复 `onMounted` 注册逻辑，统一在单一入口完成 `loadProject` 与 `beforeunload` 监听初始化。
+9. 新增 `frontend/src/composables/useSetupConfig.ts`：
+   - 将 setup-config 相关 API 编排从页面中收口到 composable（获取/保存/发布/版本列表/回滚/版本删除/Excel 导入导出）。
+   - `ProjectDetail.vue` 改为依赖 composable 暴露的方法，降低页面对 API 层的直接耦合。
+10. 新增 `frontend/src/utils/setupDiffRows.ts`：
+   - 将“步骤差异明细”计算与字段路径可读化逻辑从 `ProjectDetail.vue` 抽离为工具函数。
+   - 页面保留项目主字段差异拼装，步骤差异统一由工具输出，降低页面认知负担。
+11. 将步骤标题行按钮显隐规则收敛为 `stepActionMode` 计算属性：
+   - 去除模板中多段 `activeStep === n && !isPublishedView` 分支。
+   - 保持按钮行为与权限控制不变，降低后续步骤扩展的修改面。
+
+## 验证结果
+1. `frontend npm run build` 通过。
+2. 后端 setup-config 核心文件通过 AST 语法解析检查。
+3. 当前环境 `npx tsc --noEmit` 失败主要来自项目既有依赖类型版本不匹配（`vue`/`element-plus`/`csstype`），非本轮立项配置改动引入。
+
+## 一致性核对结果
+1. 前后端 setup-config 路由一致：
+   - `GET/PUT /setup-config`
+   - `POST /setup-config/publish`
+   - `GET /setup-config/versions`
+   - `POST /setup-config/rollback`
+   - `DELETE /setup-config/versions/{target_version}`
+   - `GET /setup-config/export-excel`
+   - `POST /setup-config/import-excel`
+2. 前端 `setupConfig` 类型与后端 schema 字段一致（`published_data` 仍保留用于发布快照与差异比较）。
+
+## 下一步建议（不改行为）
+1. 拆分 `ProjectDetail.vue` 为步骤子组件（先拆 Step4-7）。
+2. 抽象通用行编辑抽屉组件，统一校验和保存流程。
+3. 使用列配置对象复用 `el-table-column` 渲染，降低重复模板。

docs/setup-config-curl-smoke.sh

@@ -0,0 +1,97 @@
+#!/usr/bin/env bash
+set -euo pipefail
+
+BASE_URL="${BASE_URL:-http://localhost}"
+EMAIL="${EMAIL:-admin@example.com}"
+PASSWORD="${PASSWORD:-admin123}"
+STUDY_ID="${STUDY_ID:-aaaaaaaa-aaaa-aaaa-aaaa-aaaaaaaaaaaa}"
+
+echo "[1/6] login: $EMAIL"
+TOKEN=$(curl -sS -X POST "$BASE_URL/api/v1/auth/login" \
+  -H 'Content-Type: application/json' \
+  -d "{\"email\":\"$EMAIL\",\"password\":\"$PASSWORD\"}" | \
+  python3 -c 'import json,sys; print(json.load(sys.stdin).get("access_token",""))')
+
+if [[ -z "$TOKEN" ]]; then
+  echo "login failed: access_token empty"
+  exit 1
+fi
+
+AUTH=(-H "Authorization: Bearer $TOKEN")
+
+echo "[2/6] get setup-config"
+GET_RESP=$(curl -sS "$BASE_URL/api/v1/studies/$STUDY_ID/setup-config" "${AUTH[@]}")
+VERSION=$(echo "$GET_RESP" | python3 -c 'import json,sys; print(json.load(sys.stdin).get("version",""))')
+if [[ -z "$VERSION" ]]; then
+  echo "get setup-config failed"
+  echo "$GET_RESP"
+  exit 1
+fi
+echo "version=$VERSION"
+
+echo "[3/6] save draft"
+PUT_PAYLOAD=$(cat <<JSON
+{
+  "expected_version": $VERSION,
+  "data": {
+    "projectMilestones": [],
+    "enrollmentPlan": {
+      "totalTarget": 123,
+      "startDate": "2026-02-01",
+      "endDate": "2026-12-31",
+      "monthlyGoalNote": "curl smoke",
+      "stageBreakdown": "phase-1"
+    },
+    "siteMilestones": [],
+    "siteEnrollmentPlans": [],
+    "monitoringStrategies": [],
+    "centerConfirm": []
+  }
+}
+JSON
+)
+PUT_RESP=$(curl -sS -X PUT "$BASE_URL/api/v1/studies/$STUDY_ID/setup-config" \
+  "${AUTH[@]}" -H 'Content-Type: application/json' -d "$PUT_PAYLOAD")
+VERSION=$(echo "$PUT_RESP" | python3 -c 'import json,sys; print(json.load(sys.stdin).get("version",""))')
+if [[ -z "$VERSION" ]]; then
+  echo "save draft failed"
+  echo "$PUT_RESP"
+  exit 1
+fi
+echo "saved version=$VERSION"
+
+echo "[4/6] publish"
+PUB_RESP=$(curl -sS -X POST "$BASE_URL/api/v1/studies/$STUDY_ID/setup-config/publish" \
+  "${AUTH[@]}" -H 'Content-Type: application/json' -d "{\"expected_version\":$VERSION}")
+PUB_STATUS=$(echo "$PUB_RESP" | python3 -c 'import json,sys; print(json.load(sys.stdin).get("publish_status",""))')
+VERSION=$(echo "$PUB_RESP" | python3 -c 'import json,sys; print(json.load(sys.stdin).get("version",""))')
+if [[ "$PUB_STATUS" != "PUBLISHED" ]]; then
+  echo "publish failed"
+  echo "$PUB_RESP"
+  exit 1
+fi
+echo "publish_status=$PUB_STATUS version=$VERSION"
+
+echo "[5/6] export excel"
+EXCEL_FILE="/tmp/setup-config-export.xlsx"
+curl -sS "$BASE_URL/api/v1/studies/$STUDY_ID/setup-config/export-excel" "${AUTH[@]}" -o "$EXCEL_FILE"
+if [[ ! -s "$EXCEL_FILE" ]]; then
+  echo "export excel failed"
+  exit 1
+fi
+echo "export saved: $EXCEL_FILE"
+
+echo "[6/6] import excel (re-import export file)"
+IMP_RESP=$(curl -sS -X POST "$BASE_URL/api/v1/studies/$STUDY_ID/setup-config/import-excel" \
+  "${AUTH[@]}" \
+  -F "expected_version=$VERSION" \
+  -F "file=@$EXCEL_FILE;type=application/vnd.openxmlformats-officedocument.spreadsheetml.sheet")
+IMP_VER=$(echo "$IMP_RESP" | python3 -c 'import json,sys; print(json.load(sys.stdin).get("version",""))')
+if [[ -z "$IMP_VER" ]]; then
+  echo "import failed"
+  echo "$IMP_RESP"
+  exit 1
+fi
+echo "import version=$IMP_VER"
+
+echo "setup-config curl smoke passed"

frontend/dist/index.html

@@ -3,9 +3,10 @@
   <head>
     <meta charset="UTF-8" />
     <meta name="viewport" content="width=device-width, initial-scale=1.0" />
+    <link rel="icon" href="data:," />
     <title>CTMS</title>
-    <script type="module" crossorigin src="/assets/index-CsWv41CQ.js"></script>
-    <link rel="stylesheet" crossorigin href="/assets/index-B7Ge_Ohp.css">
+    <script type="module" crossorigin src="/assets/index-DNEAoWP5.js"></script>
+    <link rel="stylesheet" crossorigin href="/assets/index-J1iXJzyy.css">
   </head>
   <body>
     <div id="app"></div>

frontend/index.html

@@ -3,6 +3,7 @@
   <head>
     <meta charset="UTF-8" />
     <meta name="viewport" content="width=device-width, initial-scale=1.0" />
+    <link rel="icon" href="data:," />
     <title>CTMS</title>
   </head>
   <body>

frontend/src/api/axios.ts

@@ -16,6 +16,7 @@ const instance: AxiosInstance = axios.create({
 export type ApiRequestConfig = AxiosRequestConfig & {
   ignoreIdle?: boolean;
   allowWhileLocked?: boolean;
+  suppressErrorMessage?: boolean;
   _retry?: boolean;
 };
 
@@ -52,7 +53,10 @@ instance.interceptors.response.use(
   (response: AxiosResponse) => response,
   async (error: AxiosError<ApiError>) => {
     if (error instanceof LockedError) {
+      const lockedConfig = error.config as ApiRequestConfig | undefined;
+      if (!lockedConfig?.suppressErrorMessage) {
         ElMessage.warning(TEXT.common.messages.sessionLocked || "请解锁后继续操作");
+      }
       return Promise.reject(error);
     }
     const status = error.response?.status;
@@ -93,11 +97,19 @@ instance.interceptors.response.use(
       }
     } else if (status === 403 && (data as any)?.detail === "账号已停用") {
       forceLogout();
-    } else if (data?.message || (data as any)?.detail) {
-      ElMessage.error((data as any)?.message || (data as any)?.detail);
+    } else {
+      const suppressErrorMessage = (error.config as ApiRequestConfig | undefined)?.suppressErrorMessage;
+      if (!suppressErrorMessage) {
+        if (data?.message || (data as any)?.detail) {
+          const detail = (data as any)?.detail;
+          const detailMessage =
+            typeof detail === "string" ? detail : typeof detail?.message === "string" ? detail.message : undefined;
+          ElMessage.error((data as any)?.message || detailMessage || TEXT.common.messages.requestFailed);
         } else {
           ElMessage.error(TEXT.common.messages.requestFailed);
         }
+      }
+    }
     return Promise.reject(error);
   }
 );
@@ -107,6 +119,8 @@ export const apiPost = <T = unknown>(url: string, data?: unknown, config?: ApiRe
   instance.post<T>(url, data, config);
 export const apiPatch = <T = unknown>(url: string, data?: unknown, config?: ApiRequestConfig) =>
   instance.patch<T>(url, data, config);
+export const apiPut = <T = unknown>(url: string, data?: unknown, config?: ApiRequestConfig) =>
+  instance.put<T>(url, data, config);
 export const apiDelete = <T = unknown>(url: string, config?: ApiRequestConfig) =>
   instance.delete<T>(url, config);
 

frontend/src/api/studies.ts

@@ -1,5 +1,12 @@
-import { apiGet, apiPatch, apiPost, apiDelete } from "./axios";
+import { apiGet, apiPatch, apiPost, apiDelete, apiPut } from "./axios";
 import type { ApiListResponse, Study } from "../types/api";
+import type {
+  StudySetupConfigPublishPayload,
+  StudySetupConfigResponse,
+  StudySetupConfigRollbackPayload,
+  StudySetupConfigUpsertPayload,
+  StudySetupConfigVersionItem,
+} from "../types/setupConfig";
 
 // Backend expects trailing slash to avoid 307 redirect
 export const fetchStudies = () => apiGet<ApiListResponse<Study>>("/api/v1/studies/");
@@ -18,3 +25,26 @@ export const deleteStudy = (studyId: string) =>
 export const lockStudy = (studyId: string) =>
   apiPatch<Study>(`/api/v1/studies/${studyId}/lock`, {});
 
+export const fetchStudySetupConfig = (studyId: string) =>
+  apiGet<StudySetupConfigResponse>(`/api/v1/studies/${studyId}/setup-config`, { suppressErrorMessage: true });
+
+export const saveStudySetupConfig = (studyId: string, payload: StudySetupConfigUpsertPayload) =>
+  apiPut<StudySetupConfigResponse>(`/api/v1/studies/${studyId}/setup-config`, payload, { suppressErrorMessage: true });
+
+export const publishStudySetupConfig = (studyId: string, payload: StudySetupConfigPublishPayload) =>
+  apiPost<StudySetupConfigResponse>(`/api/v1/studies/${studyId}/setup-config/publish`, payload, { suppressErrorMessage: true });
+
+export const fetchStudySetupConfigVersions = (studyId: string) =>
+  apiGet<StudySetupConfigVersionItem[]>(`/api/v1/studies/${studyId}/setup-config/versions`, { suppressErrorMessage: true });
+
+export const deleteStudySetupConfigVersion = (studyId: string, targetVersion: number) =>
+  apiDelete(`/api/v1/studies/${studyId}/setup-config/versions/${targetVersion}`, { suppressErrorMessage: true });
+
+export const rollbackStudySetupConfig = (studyId: string, payload: StudySetupConfigRollbackPayload) =>
+  apiPost<StudySetupConfigResponse>(`/api/v1/studies/${studyId}/setup-config/rollback`, payload, { suppressErrorMessage: true });
+
+export const exportStudySetupConfigExcel = (studyId: string) =>
+  apiGet<Blob>(`/api/v1/studies/${studyId}/setup-config/export-excel`, { responseType: "blob", suppressErrorMessage: true });
+
+export const importStudySetupConfigExcel = (studyId: string, payload: FormData) =>
+  apiPost<StudySetupConfigResponse>(`/api/v1/studies/${studyId}/setup-config/import-excel`, payload, { suppressErrorMessage: true });

frontend/src/components/Layout.vue

@@ -39,6 +39,10 @@
             <el-icon><House /></el-icon>
             <span>{{ TEXT.menu.projectOverview }}</span>
           </el-menu-item>
+          <el-menu-item index="/project/milestones">
+            <el-icon><Calendar /></el-icon>
+            <span>{{ TEXT.menu.projectMilestones }}</span>
+          </el-menu-item>
           <el-sub-menu index="fees">
             <template #title>
               <el-icon><Coin /></el-icon>
@@ -47,10 +51,15 @@
             <el-menu-item index="/fees/contracts">{{ TEXT.menu.feeContracts }}</el-menu-item>
             <el-menu-item index="/fees/special">{{ TEXT.menu.feeSpecials }}</el-menu-item>
           </el-sub-menu>
-          <el-menu-item index="/drug/shipments">
+          <el-sub-menu index="materials">
+            <template #title>
               <el-icon><Box /></el-icon>
-            <span>{{ TEXT.menu.drugShipments }}</span>
-          </el-menu-item>
+              <span>{{ TEXT.menu.materialManagement }}</span>
+            </template>
+            <el-menu-item index="/drug/shipments">{{ TEXT.menu.drugShipments }}</el-menu-item>
+            <el-menu-item index="/materials/equipment">{{ TEXT.menu.materialEquipment }}</el-menu-item>
+            <el-menu-item index="/materials/others">{{ TEXT.menu.materialOthers }}</el-menu-item>
+          </el-sub-menu>
           <el-menu-item index="/file-versions">
             <el-icon><Files /></el-icon>
             <span>{{ TEXT.menu.fileVersionManagement }}</span>
@@ -67,13 +76,22 @@
             <el-icon><User /></el-icon>
             <span>{{ TEXT.menu.subjects }}</span>
           </el-menu-item>
-          <el-menu-item index="/monitoring">
-            <el-icon><ChatDotRound /></el-icon>
-            <span>{{ TEXT.menu.monitoring }}</span>
-          </el-menu-item>
-          <el-menu-item index="/audit">
+          <el-sub-menu index="risk-issues">
+            <template #title>
               <el-icon><Flag /></el-icon>
-            <span>{{ TEXT.menu.audit }}</span>
+              <span>{{ TEXT.menu.riskIssues }}</span>
+            </template>
+            <el-menu-item index="/risk-issues/sae">{{ TEXT.menu.riskIssueSae }}</el-menu-item>
+            <el-menu-item index="/risk-issues/pd">{{ TEXT.menu.riskIssuePd }}</el-menu-item>
+            <el-menu-item index="/risk-issues/monitoring-visits">{{ TEXT.menu.riskIssueMonitoringVisits }}</el-menu-item>
+          </el-sub-menu>
+          <el-menu-item index="/monitoring-audit">
+            <el-icon><ChatDotRound /></el-icon>
+            <span>{{ TEXT.menu.monitoringAudit }}</span>
+          </el-menu-item>
+          <el-menu-item index="/etmf">
+            <el-icon><Flag /></el-icon>
+            <span>{{ TEXT.menu.etmf }}</span>
           </el-menu-item>
           <el-sub-menu index="knowledge">
             <template #title>
@@ -152,9 +170,9 @@
                 shape="square"
                 class="user-avatar-comp"
               >
-                {{ (auth.user?.username || auth.user?.email || TEXT.common.labels.userInitialFallback).charAt(0).toUpperCase() }}
+                {{ userDisplayInitial }}
               </el-avatar>
-              <span class="username">{{ auth.user?.username || auth.user?.email || TEXT.common.labels.userFallback }}</span>
+              <span class="username">{{ userDisplayName }}</span>
               <el-icon><ArrowDown /></el-icon>
             </span>
             <template #dropdown>
@@ -208,22 +226,36 @@ const route = useRoute();
 const isAdmin = computed(() => auth.user?.role === "ADMIN");
 const isPm = computed(() => auth.user?.role === "PM" || study.currentStudyRole === "PM");
 const isCollapsed = ref(localStorage.getItem("ctms_sidebar_collapsed") === "1");
+const userDisplayName = computed(
+  () => auth.user?.full_name || auth.user?.username || auth.user?.email || TEXT.common.labels.userFallback
+);
+const userDisplayInitial = computed(() => {
+  const source = auth.user?.full_name || auth.user?.username || auth.user?.email || TEXT.common.labels.userInitialFallback;
+  return source.charAt(0).toUpperCase();
+});
 const activeMenu = computed(() => {
   const path = route.path;
+  if (path.startsWith("/project/milestones")) return "/project/milestones";
   if (path.startsWith("/project/")) return "/project/overview";
   if (path.startsWith("/fees/contracts")) return "/fees/contracts";
   if (path.startsWith("/fees/special")) return "/fees/special";
   if (path.startsWith("/finance/contracts")) return "/fees/contracts";
   if (path.startsWith("/finance/special")) return "/fees/special";
   if (path.startsWith("/drug/shipments")) return "/drug/shipments";
+  if (path.startsWith("/materials/equipment")) return "/materials/equipment";
+  if (path.startsWith("/materials/others")) return "/materials/others";
   if (path.startsWith("/file-versions") || path.startsWith("/trial/") || path.startsWith("/documents/")) return "/file-versions";
   if (path.startsWith("/startup/feasibility") || path.startsWith("/startup/ethics")) return "/startup/feasibility-ethics";
   if (path.startsWith("/startup/meeting-auth") || path.startsWith("/startup/kickoff") || path.startsWith("/startup/training")) {
     return "/startup/meeting-auth";
   }
   if (path.startsWith("/subjects")) return "/subjects";
-  if (path.startsWith("/monitoring")) return "/monitoring";
-  if (path.startsWith("/audit")) return "/audit";
+  if (path.startsWith("/risk-issues/sae")) return "/risk-issues/sae";
+  if (path.startsWith("/risk-issues/pd")) return "/risk-issues/pd";
+  if (path.startsWith("/risk-issues/monitoring-visits")) return "/risk-issues/monitoring-visits";
+  if (path.startsWith("/risk-issues")) return "/risk-issues/sae";
+  if (path.startsWith("/monitoring-audit") || path.startsWith("/monitoring") || path.startsWith("/audit")) return "/monitoring-audit";
+  if (path.startsWith("/etmf")) return "/etmf";
   if (path.startsWith("/knowledge/medical-consult")) return "/knowledge/medical-consult";
   if (path.startsWith("/knowledge/notes")) return "/knowledge/notes";
   if (path.startsWith("/knowledge/support-files")) return "/knowledge/support-files";
@@ -284,8 +316,16 @@ const breadcrumbs = computed(() => {
     const moduleMap: Record<string, { label: string, path: string }> = {
       "/fees/contracts": { label: TEXT.menu.feeContracts, path: "/fees/contracts" },
       "/fees/special": { label: TEXT.menu.feeSpecials, path: "/fees/special" },
+      "/project/milestones": { label: TEXT.menu.projectMilestones, path: "/project/milestones" },
       "/drug/shipments": { label: TEXT.menu.drugShipments, path: "/drug/shipments" },
+      "/materials/equipment": { label: TEXT.menu.materialEquipment, path: "/materials/equipment" },
+      "/materials/others": { label: TEXT.menu.materialOthers, path: "/materials/others" },
       "/subjects": { label: TEXT.menu.subjects, path: "/subjects" },
+      "/risk-issues/sae": { label: TEXT.menu.riskIssueSae, path: "/risk-issues/sae" },
+      "/risk-issues/pd": { label: TEXT.menu.riskIssuePd, path: "/risk-issues/pd" },
+      "/risk-issues/monitoring-visits": { label: TEXT.menu.riskIssueMonitoringVisits, path: "/risk-issues/monitoring-visits" },
+      "/monitoring-audit": { label: TEXT.menu.monitoringAudit, path: "/monitoring-audit" },
+      "/etmf": { label: TEXT.menu.etmf, path: "/etmf" },
       "/startup/feasibility": { label: TEXT.menu.startupFeasibilityEthics, path: "/startup/feasibility-ethics" },
       "/startup/ethics": { label: TEXT.menu.startupFeasibilityEthics, path: "/startup/feasibility-ethics" },
       "/startup/kickoff": { label: TEXT.menu.startupMeetingAuth, path: "/startup/meeting-auth" },
@@ -359,7 +399,15 @@ const onLogout = () => {
   router.replace("/login");
 };
 
-onMounted(() => {
+onMounted(async () => {
+  if (auth.token && !auth.user) {
+    try {
+      await auth.fetchMe();
+    } catch {
+      onLogout();
+      return;
+    }
+  }
   loadStudies();
 });
 
@@ -382,7 +430,7 @@ const onCommand = (cmd: string) => {
   background-color: #2c3e50;
   display: flex;
   flex-direction: column;
-  box-shadow: 0 0 15px rgba(0, 0, 0, 0.1);
+  box-shadow: 0 0 12px rgba(0, 0, 0, 0.08);
   z-index: 10;
   border-right: none;
   transition: width 0.18s ease;
@@ -409,10 +457,10 @@ const onCommand = (cmd: string) => {
 }
 
 .aside-logo {
-  height: 64px;
+  height: 56px;
   display: flex;
   align-items: center;
-  padding: 0 16px;
+  padding: 0 14px;
   background-color: transparent;
   transition: padding 0.18s ease;
 }
@@ -438,12 +486,12 @@ const onCommand = (cmd: string) => {
   border-right: none;
   background-color: transparent;
   flex: 1;
-  padding: 12px 0;
+  padding: 4px 0;
   overflow-y: auto;
 }
 
 .menu-divider {
-  padding: 16px 16px 8px;
+  padding: 8px 14px 2px;
   font-size: 10px;
   font-weight: 700;
   color: rgba(255, 255, 255, 0.4);
@@ -452,10 +500,10 @@ const onCommand = (cmd: string) => {
 }
 
 .layout-aside :deep(.el-menu-item) {
-  height: 44px;
-  line-height: 44px;
-  margin: 4px 10px;
-  border-radius: 8px;
+  height: 34px;
+  line-height: 34px;
+  margin: 1px 8px;
+  border-radius: 7px;
   color: #f1f5f9 !important;
   transition: var(--ctms-transition);
 }
@@ -475,19 +523,19 @@ const onCommand = (cmd: string) => {
   content: "";
   position: absolute;
   left: 0;
-  top: 10px;
-  bottom: 10px;
+  top: 8px;
+  bottom: 8px;
   width: 3px;
-  background-color: #3b82f6;
+  background-color: #94b8d1;
   border-radius: 0 4px 4px 0;
 }
 
 .layout-aside :deep(.el-sub-menu__title) {
   color: #f1f5f9 !important;
-  margin: 4px 10px;
-  border-radius: 8px;
-  height: 44px;
-  line-height: 44px;
+  margin: 1px 8px;
+  border-radius: 7px;
+  height: 34px;
+  line-height: 34px;
 }
 
 .layout-aside :deep(.el-sub-menu__title:hover) {
@@ -505,8 +553,8 @@ const onCommand = (cmd: string) => {
 }
 
 .layout-aside :deep(.el-menu--inline .el-menu-item) {
-  padding-left: 48px !important;
-  margin: 2px 12px;
+  padding-left: 40px !important;
+  margin: 0 10px;
 }
 
 .layout-header {
@@ -514,20 +562,24 @@ const onCommand = (cmd: string) => {
   display: flex;
   align-items: center;
   justify-content: space-between;
-  padding: 0 24px;
+  padding: 0 10px;
   box-shadow: none;
-  height: 64px !important;
+  height: 52px !important;
   z-index: 9;
   border-bottom: 1px solid #f1f5f9;
 }
 
+.main-container {
+  background: #f7f8fb;
+}
+
 .header-breadcrumb {
   display: flex;
   align-items: center;
-  gap: 8px;
+  gap: 6px;
   color: var(--ctms-text-regular);
-  font-size: 14px;
-  margin-left: 20px;
+  font-size: 13px;
+  margin-left: 14px;
   user-select: none;
 }
 
@@ -570,7 +622,7 @@ const onCommand = (cmd: string) => {
 .header-right {
   display: flex;
   align-items: center;
-  gap: 20px;
+  gap: 12px;
 }
 
 .header-left {
@@ -603,7 +655,7 @@ const onCommand = (cmd: string) => {
   border: 1px solid var(--ctms-border-color);
   color: var(--ctms-text-regular);
   transition: var(--ctms-transition);
-  height: 40px;
+  height: 36px;
 }
 
 .dropdown-trigger.compact:hover {
@@ -633,11 +685,13 @@ const onCommand = (cmd: string) => {
 .layout-main {
   padding: 0;
   overflow-y: auto;
+  background: #f7f8fb;
 }
 
 .content-wrapper {
-  padding: 16px;
-  min-height: calc(100vh - 64px);
+  padding: 6px 8px;
+  min-height: calc(100vh - 52px);
+  background: #f7f8fb;
 }
 
 /* 过渡动画 */

frontend/src/components/LockScreenModal.vue

@@ -4,11 +4,14 @@
       <div class="lock-backdrop" />
       <div class="lock-panel">
         <h2 class="lock-title">已锁定</h2>
-        <p class="lock-desc">30 分钟无操作，请输入密码解锁</p>
+        <p class="lock-desc">30 分钟无操作将锁定，2 小时无操作将自动退出登录</p>
+        <p class="lock-countdown">剩余自动登出：{{ autoLogoutCountdown }}</p>
         <el-input
           ref="passwordInput"
           v-model="password"
           type="password"
+          autocomplete="new-password"
+          name="lock-password"
           placeholder="请输入登录密码"
           show-password
           @keyup.enter="onUnlock"
@@ -24,11 +27,16 @@
 </template>
 
 <script setup lang="ts">
-import { nextTick, onMounted, ref, watch } from "vue";
+import { computed, nextTick, onMounted, onUnmounted, ref, watch } from "vue";
 import { ElMessage } from "element-plus";
 import { useAuthStore } from "../store/auth";
 import { useSessionStore } from "../store/session";
-import { UNLOCK_MAX_ATTEMPTS, unlockWithPassword, forceLogout } from "../session/sessionManager";
+import {
+  AUTO_LOGOUT_TIMEOUT_HOURS,
+  UNLOCK_MAX_ATTEMPTS,
+  unlockWithPassword,
+  forceLogout,
+} from "../session/sessionManager";
 
 const auth = useAuthStore();
 const session = useSessionStore();
@@ -36,6 +44,41 @@ const password = ref("");
 const loading = ref(false);
 const errorMessage = ref("");
 const passwordInput = ref<{ focus?: () => void } | null>(null);
+const nowTs = ref(Date.now());
+let countdownTimer: number | null = null;
+
+const pad2 = (value: number) => String(value).padStart(2, "0");
+
+const autoLogoutCountdown = computed(() => {
+  const fallbackDeadlineAt =
+    Math.min(session.lastUserActiveAt, session.lastNetworkActiveAt) + AUTO_LOGOUT_TIMEOUT_HOURS * 60 * 60 * 1000;
+  const deadlineAt = session.lockAutoLogoutDeadlineAt || fallbackDeadlineAt;
+  const remainMs = Math.max(0, deadlineAt - nowTs.value);
+  const remainSec = Math.floor(remainMs / 1000);
+  const hours = Math.floor(remainSec / 3600);
+  const minutes = Math.floor((remainSec % 3600) / 60);
+  const seconds = remainSec % 60;
+  if (hours > 0) {
+    return `${pad2(hours)}:${pad2(minutes)}:${pad2(seconds)}`;
+  }
+  return `${pad2(minutes)}:${pad2(seconds)}`;
+});
+
+const startCountdown = () => {
+  if (countdownTimer) {
+    window.clearInterval(countdownTimer);
+  }
+  nowTs.value = Date.now();
+  countdownTimer = window.setInterval(() => {
+    nowTs.value = Date.now();
+  }, 1000);
+};
+
+const stopCountdown = () => {
+  if (!countdownTimer) return;
+  window.clearInterval(countdownTimer);
+  countdownTimer = null;
+};
 
 const focusPassword = () => {
   nextTick(() => {
@@ -43,10 +86,23 @@ const focusPassword = () => {
   });
 };
 
+const resolveUnlockEmail = async () => {
+  if (session.lockEmail) return session.lockEmail;
+  if (auth.user?.email) return auth.user.email;
+  const cachedEmail = localStorage.getItem("ctms_last_login_email");
+  if (cachedEmail) return cachedEmail;
+  try {
+    const me = await auth.fetchMe();
+    return me?.email || "";
+  } catch {
+    return "";
+  }
+};
+
 const onUnlock = async () => {
   if (loading.value) return;
   errorMessage.value = "";
-  const email = auth.user?.email;
+  const email = await resolveUnlockEmail();
   if (!email) {
     ElMessage.error("无法获取用户信息，请重新登录");
     forceLogout();
@@ -63,7 +119,7 @@ const onUnlock = async () => {
     password.value = "";
   } catch (err: any) {
     session.incrementUnlockAttempt();
-    const message = err?.response?.data?.detail || err?.response?.data?.message || "密码错误";
+    const message = err?.response?.data?.detail || err?.response?.data?.message || err?.message || "密码错误";
     errorMessage.value = message;
     if (session.unlockAttempts >= UNLOCK_MAX_ATTEMPTS) {
       ElMessage.error("错误次数过多，请重新登录");
@@ -80,17 +136,33 @@ const onLogout = () => {
 };
 
 onMounted(() => {
+  password.value = "";
+  errorMessage.value = "";
   focusPassword();
+  if (session.locked) {
+    startCountdown();
+  }
 });
 
 watch(
   () => session.locked,
   (value) => {
     if (value) {
+      password.value = "";
+      errorMessage.value = "";
       focusPassword();
+      startCountdown();
+      return;
     }
+    password.value = "";
+    errorMessage.value = "";
+    stopCountdown();
   }
 );
+
+onUnmounted(() => {
+  stopCountdown();
+});
 </script>
 
 <style scoped>
@@ -135,6 +207,13 @@ watch(
   font-size: 14px;
 }
 
+.lock-countdown {
+  margin: -4px 0 0;
+  color: #1d4ed8;
+  font-size: 13px;
+  font-weight: 600;
+}
+
 .lock-actions {
   display: flex;
   gap: 12px;

frontend/src/composables/useSetupConfig.ts

@@ -0,0 +1,38 @@
+import {
+  deleteStudySetupConfigVersion,
+  exportStudySetupConfigExcel,
+  fetchStudySetupConfig,
+  fetchStudySetupConfigVersions,
+  importStudySetupConfigExcel,
+  publishStudySetupConfig,
+  rollbackStudySetupConfig,
+  saveStudySetupConfig,
+} from "../api/studies";
+import type {
+  StudySetupConfigPublishPayload,
+  StudySetupConfigRollbackPayload,
+  StudySetupConfigUpsertPayload,
+} from "../types/setupConfig";
+
+export const useSetupConfig = () => {
+  const getConfig = (studyId: string) => fetchStudySetupConfig(studyId);
+  const saveConfig = (studyId: string, payload: StudySetupConfigUpsertPayload) => saveStudySetupConfig(studyId, payload);
+  const publishConfig = (studyId: string, payload: StudySetupConfigPublishPayload) => publishStudySetupConfig(studyId, payload);
+  const listVersions = (studyId: string) => fetchStudySetupConfigVersions(studyId);
+  const rollbackConfig = (studyId: string, payload: StudySetupConfigRollbackPayload) => rollbackStudySetupConfig(studyId, payload);
+  const deleteVersion = (studyId: string, targetVersion: number) => deleteStudySetupConfigVersion(studyId, targetVersion);
+  const exportExcel = (studyId: string) => exportStudySetupConfigExcel(studyId);
+  const importExcel = (studyId: string, payload: FormData) => importStudySetupConfigExcel(studyId, payload);
+
+  return {
+    getConfig,
+    saveConfig,
+    publishConfig,
+    listVersions,
+    rollbackConfig,
+    deleteVersion,
+    exportExcel,
+    importExcel,
+  };
+};
+

frontend/src/locales/zh-CN.ts

@@ -141,6 +141,9 @@ export const TEXT = {
       severity: "严重等级",
       causality: "关联性",
       outcome: "结局",
+      aeType: "AE 类型",
+      isSae: "是否 SAE",
+      isSusar: "是否 SUSAR",
       submitDate: "递交日期",
       acceptDate: "受理日期",
       approvedDate: "批准日期",
@@ -236,6 +239,11 @@ export const TEXT = {
       FINANCE_REJECTED: { label: "费用驳回", actionText: "驳回了费用", targetLabel: "费用" },
       IMP_CONFIRMED: { label: "药品出入库确认", actionText: "确认了药品出入库记录", targetLabel: "药品交易" },
       QUERY_RESOLVED: { label: "数据问题解决", actionText: "标记数据问题已解决", targetLabel: "数据问题" },
+      CREATE_SETUP_CONFIG: { label: "初始化立项配置", actionText: "初始化了立项配置", targetLabel: "立项配置" },
+      UPDATE_SETUP_CONFIG: { label: "保存立项配置", actionText: "更新了立项配置草稿", targetLabel: "立项配置" },
+      PUBLISH_SETUP_CONFIG: { label: "发布立项配置", actionText: "发布了立项配置", targetLabel: "立项配置" },
+      IMPORT_SETUP_CONFIG: { label: "导入立项配置", actionText: "导入了立项配置", targetLabel: "立项配置" },
+      IMPORT_SETUP_CONFIG_EXCEL: { label: "导入立项配置（Excel）", actionText: "通过 Excel 导入了立项配置", targetLabel: "立项配置" },
     },
   },
   menu: {
@@ -246,17 +254,27 @@ export const TEXT = {
     auditLogs: "审计日志",
     currentProject: "当前项目",
     projectOverview: "项目总览",
+    projectMilestones: "项目里程碑",
     finance: "费用管理",
     financeContracts: "合同管理",
     financeSpecials: "特殊费用管理",
     feeContracts: "合同管理",
     feeSpecials: "特殊费用管理",
     drug: "药品管理",
+    materialManagement: "物资管理",
     drugShipments: "药品流向管理",
+    materialEquipment: "设备管理",
+    materialOthers: "其他",
     fileVersionManagement: "文件版本管理",
     startupFeasibilityEthics: "立项与伦理",
     startupMeetingAuth: "启动与授权",
     subjects: "参与者管理",
+    riskIssues: "风险问题",
+    riskIssueSae: "AE/SAE",
+    riskIssuePd: "PD",
+    riskIssueMonitoringVisits: "监查访视问题",
+    monitoringAudit: "监查稽查",
+    etmf: "eTMF",
     monitoring: "监查",
     audit: "稽查",
     sharedLibrary: "共享库",
@@ -316,6 +334,12 @@ export const TEXT = {
       notificationsSubtitle: "文件版本更新将推送在此处",
       notificationsEmpty: "暂无通知",
     },
+    projectMilestones: {
+      title: "项目里程碑",
+      subtitle: "里程碑计划与执行跟踪",
+      listTitle: "里程碑列表",
+      emptyDescription: "项目里程碑模块正在建设中，敬请期待。",
+    },
     financeContracts: {
       title: "合同费用",
       subtitle: "维护分中心合同费用与附件",
@@ -443,6 +467,18 @@ export const TEXT = {
       detailTitle: "运输记录详情",
       detailSubtitle: "查看药品流向信息与附件",
     },
+    materialEquipment: {
+      title: "设备管理",
+      subtitle: "设备台账与状态跟踪",
+      listTitle: "设备列表",
+      emptyDescription: "设备管理模块正在建设中，敬请期待。",
+    },
+    materialOthers: {
+      title: "其他物资",
+      subtitle: "其他物资登记与管理",
+      listTitle: "物资列表",
+      emptyDescription: "其他物资模块正在建设中，敬请期待。",
+    },
     fileVersionManagement: {
       title: "文件版本管理",
       subtitle: "管理试验文档与版本审批",
@@ -610,19 +646,55 @@ export const TEXT = {
     },
     subjectDetail: {
       title: "参与者详情",
-      subtitle: "查看病史、访视与 AE 信息",
+      subtitle: "查看病史、访视、AE 与 PD 信息",
       tabs: {
         history: "病史",
         visits: "访视",
         ae: "AE 信息",
+        pd: "PD",
+      },
+      aeType: {
+        ae: "AE",
+        sae: "SAE",
+        susar: "SUSAR",
       },
       emptyHistory: "暂无病史记录",
       emptyVisits: "暂无访视记录",
       emptyAe: "暂无 AE 记录",
+      emptyPd: "暂无 PD 记录",
       dialogHistory: "病史记录",
       dialogVisit: "访视记录",
       dialogAe: "AE 记录",
     },
+    riskIssues: {
+      title: "风险问题",
+      subtitle: "项目风险与问题跟踪管理",
+      listTitle: "风险问题列表",
+      emptyDescription: "风险问题模块正在建设中，敬请期待。",
+    },
+    riskIssueSae: {
+      title: "AE/SAE",
+      subtitle: "同步参与者 AE/SAE 信息列表",
+      listTitle: "AE/SAE 列表",
+      emptyDescription: "暂无 AE/SAE 记录",
+      subjectNo: "参与者编号",
+      toSubject: "查看参与者",
+    },
+    riskIssuePd: {
+      title: "PD",
+      subtitle: "同步参与者 PD 相关信息列表",
+      listTitle: "PD 列表",
+      emptyDescription: "暂无参与者记录",
+      syncStatus: "同步状态",
+      synced: "已同步",
+      toSubject: "查看参与者",
+    },
+    riskIssueMonitoringVisits: {
+      title: "监查访视问题",
+      subtitle: "功能建设中",
+      listTitle: "监查访视问题列表",
+      emptyDescription: "监查访视问题模块正在建设中，敬请期待。",
+    },
     knowledgeMedicalConsult: {
       title: "医学咨询",
       subtitle: "常见问题与答复",
@@ -695,6 +767,18 @@ export const TEXT = {
       listTitle: "稽查记录列表",
       emptyDescription: "稽查模块正在准备基础框架，敬请期待。",
     },
+    monitoringAudit: {
+      title: "监查稽查",
+      subtitle: "功能建设中",
+      listTitle: "监查稽查列表",
+      emptyDescription: "监查稽查模块正在建设中，敬请期待。",
+    },
+    etmf: {
+      title: "eTMF",
+      subtitle: "功能建设中",
+      listTitle: "eTMF 列表",
+      emptyDescription: "eTMF 模块正在建设中，敬请期待。",
+    },
     adminUserApproval: {
       title: "注册审核",
       subtitle: "仅显示待审核账号，审核通过后即可登录",
@@ -770,7 +854,6 @@ export const TEXT = {
       createdAt: "创建时间",
       newTitle: "新建项目",
       editTitle: "编辑项目",
-      visitTemplate: "访视模板",
       sponsorPlaceholder: "申办方（可选）",
       protocolPlaceholder: "方案号（可选）",
       phasePlaceholder: "研究分期（可选）",
@@ -780,6 +863,9 @@ export const TEXT = {
       detailTitle: "项目详情",
       basicInfo: "项目基本信息",
       filesTitle: "项目通用文件",
+      setupStepCenterConfirm: "中心确认",
+      setupSaveSuccess: "配置草稿已保存",
+      setupSaveFailed: "配置草稿保存失败",
       lockConfirmPrompt: "请输入“确认锁定”以继续",
       lockConfirmTitle: "二次确认",
       lockConfirmPlaceholder: "请输入确认锁定",
@@ -828,6 +914,7 @@ export const TEXT = {
       contactPlaceholder: "选择项目成员作为负责人，可多选",
       updateSuccess: "中心已更新",
       createSuccess: "中心已创建",
+      leadUnitTag: "组长单位",
       disableConfirm: "该操作将影响中心数据，请确认是否继续",
       disableTitle: "停用中心",
       disableSuccess: "已停用",
@@ -842,6 +929,7 @@ export const TEXT = {
     },
     adminAuditLogs: {
       title: "审计日志",
+      filterEntityType: "对象类型",
       filterEvent: "操作类型",
       filterOperator: "操作人",
       filterResult: "结果",

frontend/src/main.ts

@@ -6,6 +6,7 @@ import dayjs from "dayjs";
 import "dayjs/locale/zh-cn";
 import "element-plus/dist/index.css";
 import "./styles/main.css";
+import "./styles/unified-page.css";
 
 import App from "./App.vue";
 import router from "./router";

frontend/src/router/index.ts

@@ -17,6 +17,7 @@ import AdminSites from "../views/admin/Sites.vue";
 import ProjectDetail from "../views/admin/ProjectDetail.vue";
 import ProfileSettings from "../views/ProfileSettings.vue";
 import ProjectOverview from "../views/ia/ProjectOverview.vue";
+import ProjectMilestones from "../views/ia/ProjectMilestones.vue";
 import FinanceContracts from "../views/ia/FinanceContracts.vue";
 import FinanceSpecial from "../views/ia/FinanceSpecial.vue";
 import FeeContracts from "../views/fees/ContractFees.vue";
@@ -26,14 +27,19 @@ import FeeSpecials from "../views/fees/SpecialExpenses.vue";
 import FeeSpecialForm from "../views/fees/SpecialExpenseForm.vue";
 import FeeSpecialDetail from "../views/fees/SpecialExpenseDetail.vue";
 import DrugShipments from "../views/ia/DrugShipments.vue";
+import MaterialEquipment from "../views/ia/MaterialEquipment.vue";
+import MaterialOthers from "../views/ia/MaterialOthers.vue";
 import FileVersionManagement from "../views/ia/FileVersionManagement.vue";
 import DocumentList from "../views/documents/DocumentList.vue";
 import DocumentDetail from "../views/documents/DocumentDetail.vue";
 import StartupFeasibilityEthics from "../views/ia/StartupFeasibilityEthics.vue";
 import StartupMeetingAuth from "../views/ia/StartupMeetingAuth.vue";
 import SubjectManagement from "../views/ia/SubjectManagement.vue";
-import MonitoringPlaceholder from "../views/ia/MonitoringPlaceholder.vue";
-import AuditPlaceholder from "../views/ia/AuditPlaceholder.vue";
+import RiskIssueSae from "../views/ia/RiskIssueSae.vue";
+import RiskIssuePd from "../views/ia/RiskIssuePd.vue";
+import RiskIssueMonitoringVisits from "../views/ia/RiskIssueMonitoringVisits.vue";
+import MonitoringAuditPlaceholder from "../views/ia/MonitoringAuditPlaceholder.vue";
+import EtmfPlaceholder from "../views/ia/EtmfPlaceholder.vue";
 import KnowledgeMedicalConsult from "../views/ia/KnowledgeMedicalConsult.vue";
 import KnowledgeNotes from "../views/ia/KnowledgeNotes.vue";
 import KnowledgeSupportFiles from "../views/ia/KnowledgeSupportFiles.vue";
@@ -100,6 +106,12 @@ const routes: RouteRecordRaw[] = [
         component: ProjectOverview,
         meta: { title: TEXT.menu.projectOverview, requiresStudy: true },
       },
+      {
+        path: "project/milestones",
+        name: "ProjectMilestones",
+        component: ProjectMilestones,
+        meta: { title: TEXT.menu.projectMilestones, requiresStudy: true },
+      },
       {
         path: "finance/contracts",
         name: "FinanceContracts",
@@ -202,6 +214,18 @@ const routes: RouteRecordRaw[] = [
         component: DrugShipments,
         meta: { title: TEXT.menu.drugShipments, requiresStudy: true },
       },
+      {
+        path: "materials/equipment",
+        name: "MaterialEquipment",
+        component: MaterialEquipment,
+        meta: { title: TEXT.menu.materialEquipment, requiresStudy: true },
+      },
+      {
+        path: "materials/others",
+        name: "MaterialOthers",
+        component: MaterialOthers,
+        meta: { title: TEXT.menu.materialOthers, requiresStudy: true },
+      },
       {
         path: "drug/shipments/new",
         name: "DrugShipmentNew",
@@ -346,17 +370,47 @@ const routes: RouteRecordRaw[] = [
         component: SubjectForm,
         meta: { title: TEXT.common.actions.edit + TEXT.menu.subjects, requiresStudy: true },
       },
+      {
+        path: "risk-issues",
+        redirect: "/risk-issues/sae",
+      },
+      {
+        path: "risk-issues/sae",
+        name: "RiskIssueSae",
+        component: RiskIssueSae,
+        meta: { title: TEXT.menu.riskIssueSae, requiresStudy: true },
+      },
+      {
+        path: "risk-issues/pd",
+        name: "RiskIssuePd",
+        component: RiskIssuePd,
+        meta: { title: TEXT.menu.riskIssuePd, requiresStudy: true },
+      },
+      {
+        path: "risk-issues/monitoring-visits",
+        name: "RiskIssueMonitoringVisits",
+        component: RiskIssueMonitoringVisits,
+        meta: { title: TEXT.menu.riskIssueMonitoringVisits, requiresStudy: true },
+      },
+      {
+        path: "monitoring-audit",
+        name: "MonitoringAuditPlaceholder",
+        component: MonitoringAuditPlaceholder,
+        meta: { title: TEXT.menu.monitoringAudit, requiresStudy: true },
+      },
       {
         path: "monitoring",
-        name: "MonitoringPlaceholder",
-        component: MonitoringPlaceholder,
-        meta: { title: TEXT.menu.monitoring, requiresStudy: true },
+        redirect: "/monitoring-audit",
       },
       {
         path: "audit",
-        name: "AuditPlaceholder",
-        component: AuditPlaceholder,
-        meta: { title: TEXT.menu.audit, requiresStudy: true },
+        redirect: "/monitoring-audit",
+      },
+      {
+        path: "etmf",
+        name: "EtmfPlaceholder",
+        component: EtmfPlaceholder,
+        meta: { title: TEXT.menu.etmf, requiresStudy: true },
       },
       {
         path: "knowledge/medical-consult",
@@ -431,6 +485,12 @@ const routes: RouteRecordRaw[] = [
         component: AdminProjects,
         meta: { title: TEXT.menu.projectManagement, requiresAdmin: true },
       },
+      {
+        path: "projects/:projectId",
+        name: "AdminProjectDetail",
+        component: ProjectDetail,
+        meta: { title: TEXT.modules.adminProjects.detailTitle, requiresAdmin: true },
+      },
       {
         path: "projects/:projectId/members",
         name: "AdminProjectMembers",
@@ -453,9 +513,7 @@ const routes: RouteRecordRaw[] = [
   },
   {
     path: "/projects/:projectId",
-    name: "ProjectDetail",
-    component: ProjectDetail,
-    meta: { title: TEXT.modules.adminProjects.detailTitle, requiresAdmin: true },
+    redirect: (to) => `/admin/projects/${to.params.projectId}`,
   },
 ];
 
@@ -468,14 +526,18 @@ router.beforeEach(async (to, _from, next) => {
   const auth = useAuthStore();
   const studyStore = useStudyStore();
   const getToken = () => auth.token;
+  let token = getToken();
   if (!auth.user && getToken()) {
     try {
       await auth.fetchMe();
     } catch {
-      // 由统一的认证处理流程处理 401/403
+      // 有 token 但无法获取用户，强制回登录，避免进入“无用户上下文”页面
+      auth.logout();
+      next({ path: "/login" });
+      return;
     }
   }
-  const token = getToken();
+  token = getToken();
   const isAdmin = auth.user?.role === "ADMIN";
   if (token && !studyStore.currentStudy) {
     if (isAdmin) {

frontend/src/session/sessionManager.ts

@@ -1,4 +1,3 @@
-import { ElMessage } from "element-plus";
 import router from "../router";
 import { useAuthStore } from "../store/auth";
 import { useSessionStore } from "../store/session";
@@ -7,16 +6,19 @@ import { extendToken, unlockSession } from "../api/authClient";
 import { parseJwtExp } from "./jwt";
 
 export const IDLE_TIMEOUT_MINUTES = 30;
+export const AUTO_LOGOUT_TIMEOUT_HOURS = 2;
 export const EXTEND_EARLY_SECONDS = 120;
 export const EXTEND_MIN_INTERVAL_SECONDS = 60;
 export const UNLOCK_MAX_ATTEMPTS = 5;
+export const LOGOUT_REASON_TIMEOUT = "timeout";
+const LOGOUT_REASON_STORAGE_KEY = "ctms_logout_reason";
 
 type BroadcastMessage =
   | { type: "ACTIVE"; at: number }
   | { type: "NETWORK"; at: number }
-  | { type: "LOCK"; reason: string }
+  | { type: "LOCK"; reason: string; email?: string; deadlineAt?: number }
   | { type: "TOKEN_UPDATED"; token: string }
-  | { type: "LOGOUT" };
+  | { type: "LOGOUT"; reason?: string };
 
 let idleTimer: number | null = null;
 let extendPromise: Promise<{ token: string | null; authFailed: boolean }> | null = null;
@@ -38,16 +40,19 @@ const handleBroadcast = (message: BroadcastMessage) => {
   const session = useSessionStore();
   const auth = useAuthStore();
   if (message.type === "ACTIVE") {
+    if (session.locked) return;
     session.recordUserActivity(message.at);
     scheduleIdleCheck();
   }
   if (message.type === "NETWORK") {
+    if (session.locked) return;
     session.recordNetworkActivity(message.at);
     scheduleIdleCheck();
   }
   if (message.type === "LOCK") {
     const reason = message.reason as "idle" | "extend_failed" | "token_invalid";
-    session.lock(reason || "idle");
+    session.lock(reason || "idle", message.email, message.deadlineAt);
+    scheduleIdleCheck();
   }
   if (message.type === "TOKEN_UPDATED") {
     auth.setToken(message.token);
@@ -55,7 +60,7 @@ const handleBroadcast = (message: BroadcastMessage) => {
     session.unlock();
   }
   if (message.type === "LOGOUT") {
-    forceLogout();
+    performLogout(message.reason);
   }
 };
 
@@ -64,9 +69,22 @@ const scheduleIdleCheck = () => {
     window.clearTimeout(idleTimer);
   }
   const session = useSessionStore();
-  const timeoutMs = IDLE_TIMEOUT_MINUTES * 60 * 1000;
-  const nextCheck =
-    Math.min(session.lastUserActiveAt, session.lastNetworkActiveAt) + timeoutMs - Date.now();
+  const now = Date.now();
+  if (session.locked) {
+    const remain = (session.lockAutoLogoutDeadlineAt || 0) - now;
+    if (remain <= 0) {
+      checkIdle();
+      return;
+    }
+    idleTimer = window.setTimeout(checkIdle, remain);
+    return;
+  }
+  const idleTimeoutMs = IDLE_TIMEOUT_MINUTES * 60 * 1000;
+  const autoLogoutMs = AUTO_LOGOUT_TIMEOUT_HOURS * 60 * 60 * 1000;
+  const baseActiveAt = Math.min(session.lastUserActiveAt, session.lastNetworkActiveAt);
+  const idleRemain = baseActiveAt + idleTimeoutMs - now;
+  const logoutRemain = baseActiveAt + autoLogoutMs - now;
+  const nextCheck = Math.min(idleRemain, logoutRemain);
   if (nextCheck <= 0) {
     checkIdle();
     return;
@@ -76,13 +94,29 @@ const scheduleIdleCheck = () => {
 
 const checkIdle = () => {
   const session = useSessionStore();
-  const timeoutMs = IDLE_TIMEOUT_MINUTES * 60 * 1000;
-  const now = Date.now();
-  if (now - session.lastUserActiveAt > timeoutMs && now - session.lastNetworkActiveAt > timeoutMs) {
-    lockSession("idle");
+  if (session.locked) {
+    const deadlineAt = session.lockAutoLogoutDeadlineAt || 0;
+    if (deadlineAt > 0 && Date.now() >= deadlineAt) {
+      forceLogout(LOGOUT_REASON_TIMEOUT);
       return;
     }
     scheduleIdleCheck();
+    return;
+  }
+  const idleTimeoutMs = IDLE_TIMEOUT_MINUTES * 60 * 1000;
+  const autoLogoutMs = AUTO_LOGOUT_TIMEOUT_HOURS * 60 * 60 * 1000;
+  const now = Date.now();
+  const idleElapsed = now - session.lastUserActiveAt > idleTimeoutMs && now - session.lastNetworkActiveAt > idleTimeoutMs;
+  const autoLogoutElapsed =
+    now - session.lastUserActiveAt > autoLogoutMs && now - session.lastNetworkActiveAt > autoLogoutMs;
+  if (autoLogoutElapsed) {
+    forceLogout(LOGOUT_REASON_TIMEOUT);
+    return;
+  }
+  if (idleElapsed) {
+    lockSession("idle");
+  }
+  scheduleIdleCheck();
 };
 
 export const initSessionManager = () => {
@@ -115,6 +149,7 @@ export const initSessionManager = () => {
 
 export const markUserActive = (at: number = Date.now()) => {
   const session = useSessionStore();
+  if (session.locked) return;
   session.recordUserActivity(at);
   broadcast({ type: "ACTIVE", at });
   scheduleIdleCheck();
@@ -122,6 +157,7 @@ export const markUserActive = (at: number = Date.now()) => {
 
 export const markNetworkActive = (at: number = Date.now()) => {
   const session = useSessionStore();
+  if (session.locked) return;
   session.recordNetworkActivity(at);
   broadcast({ type: "NETWORK", at });
   scheduleIdleCheck();
@@ -129,21 +165,53 @@ export const markNetworkActive = (at: number = Date.now()) => {
 
 export const lockSession = (reason: "idle" | "extend_failed" | "token_invalid") => {
   const session = useSessionStore();
+  const auth = useAuthStore();
   if (session.locked) return;
-  session.lock(reason);
-  broadcast({ type: "LOCK", reason });
+  const email = auth.user?.email || "";
+  const autoLogoutMs = AUTO_LOGOUT_TIMEOUT_HOURS * 60 * 60 * 1000;
+  const deadlineAt = Math.min(session.lastUserActiveAt, session.lastNetworkActiveAt) + autoLogoutMs;
+  session.lock(reason, email, deadlineAt);
+  broadcast({ type: "LOCK", reason, email, deadlineAt });
+  scheduleIdleCheck();
 };
 
-export const forceLogout = () => {
+const setLogoutReason = (reason?: string) => {
+  try {
+    if (!reason) {
+      sessionStorage.removeItem(LOGOUT_REASON_STORAGE_KEY);
+      return;
+    }
+    sessionStorage.setItem(LOGOUT_REASON_STORAGE_KEY, reason);
+  } catch {
+    /* ignore */
+  }
+};
+
+export const consumeLogoutReason = () => {
+  try {
+    const reason = sessionStorage.getItem(LOGOUT_REASON_STORAGE_KEY);
+    sessionStorage.removeItem(LOGOUT_REASON_STORAGE_KEY);
+    return reason;
+  } catch {
+    return null;
+  }
+};
+
+const performLogout = (reason?: string) => {
+  setLogoutReason(reason);
   const auth = useAuthStore();
   const session = useSessionStore();
   auth.logout();
   session.unlock();
   clearToken();
-  broadcast({ type: "LOGOUT" });
   router.replace("/login");
 };
 
+export const forceLogout = (reason?: string) => {
+  performLogout(reason);
+  broadcast({ type: "LOGOUT", reason });
+};
+
 const updateToken = (token: string) => {
   const auth = useAuthStore();
   auth.setToken(token);
@@ -205,8 +273,16 @@ export const startTokenKeepAlive = () => {
 
 export const unlockWithPassword = async (email: string, password: string) => {
   const session = useSessionStore();
+  const auth = useAuthStore();
   const { data } = await unlockSession({ email, password });
   updateToken(data.accessToken);
   session.unlock();
+  try {
+    await auth.fetchMe();
+  } catch {
+    // token已更新但用户信息拉取失败时，避免界面进入无角色状态
+    forceLogout();
+    throw new Error("无法获取用户信息，请重新登录");
+  }
   markUserActive();
 };

frontend/src/store/auth.ts

@@ -4,8 +4,10 @@ import { login as apiLogin, fetchMe } from "../api/auth";
 import { setToken, clearToken, getToken } from "../utils/auth";
 import type { UserInfo } from "../types/api";
 import { useStudyStore } from "./study";
+import { useSessionStore } from "./session";
 
 export const useAuthStore = defineStore("auth", () => {
+  const LAST_LOGIN_EMAIL_KEY = "ctms_last_login_email";
   const token = ref<string | null>(getToken());
   const user = ref<UserInfo | null>(null);
   const loading = ref(false);
@@ -17,6 +19,9 @@ export const useAuthStore = defineStore("auth", () => {
       const { data } = await apiLogin({ email, password });
       token.value = data.access_token;
       setToken(data.access_token);
+      // 避免锁屏态下 fetchMe 被请求拦截
+      useSessionStore().unlock();
+      localStorage.setItem(LAST_LOGIN_EMAIL_KEY, email);
       await fetchMeAction();
       forceLogin.value = false;
     } finally {
@@ -27,6 +32,9 @@ export const useAuthStore = defineStore("auth", () => {
   const fetchMeAction = async () => {
     const { data } = await fetchMe();
     user.value = data;
+    if (data?.email) {
+      localStorage.setItem(LAST_LOGIN_EMAIL_KEY, data.email);
+    }
     return data;
   };
 

frontend/src/store/session.ts

@@ -6,7 +6,9 @@ export type LockReason = "idle" | "extend_failed" | "token_invalid";
 export const useSessionStore = defineStore("session", () => {
   const locked = ref(false);
   const lockReason = ref<LockReason | null>(null);
+  const lockEmail = ref<string>("");
   const unlockAttempts = ref(0);
+  const lockAutoLogoutDeadlineAt = ref(0);
   const lastUserActiveAt = ref(Date.now());
   const lastNetworkActiveAt = ref(Date.now());
   const lastExtendAt = ref(0);
@@ -19,14 +21,18 @@ export const useSessionStore = defineStore("session", () => {
     lastNetworkActiveAt.value = ts;
   };
 
-  const lock = (reason: LockReason) => {
+  const lock = (reason: LockReason, email?: string, autoLogoutDeadlineAt?: number) => {
     locked.value = true;
     lockReason.value = reason;
+    lockEmail.value = (email || "").trim();
+    lockAutoLogoutDeadlineAt.value = autoLogoutDeadlineAt || 0;
   };
 
   const unlock = () => {
     locked.value = false;
     lockReason.value = null;
+    lockEmail.value = "";
+    lockAutoLogoutDeadlineAt.value = 0;
     unlockAttempts.value = 0;
   };
 
@@ -41,6 +47,8 @@ export const useSessionStore = defineStore("session", () => {
   return {
     locked,
     lockReason,
+    lockEmail,
+    lockAutoLogoutDeadlineAt,
     unlockAttempts,
     lastUserActiveAt,
     lastNetworkActiveAt,

frontend/src/styles/unified-page.css

@@ -0,0 +1,181 @@
+:root {
+  --unified-shell-bg: #ffffff;
+  --unified-shell-border: #d8e2ef;
+  --unified-shell-divider: #eaf0f8;
+  --unified-shell-radius: 16px;
+  --unified-shell-padding-x: 20px;
+  --unified-shell-padding-y: 14px;
+  --unified-title-color: #0f2345;
+  --unified-muted-color: #6f84a8;
+}
+
+.unified-shell {
+  background: var(--unified-shell-bg);
+  border: 0;
+  border-radius: var(--unified-shell-radius);
+  overflow: hidden;
+  box-shadow: none;
+}
+
+.el-card.unified-shell {
+  margin-bottom: 0;
+  border: 0 !important;
+  box-shadow: none !important;
+}
+
+.main-content-card.unified-shell {
+  border: 0 !important;
+  box-shadow: none !important;
+}
+
+.el-card.unified-shell > .el-card__body {
+  padding: 0 !important;
+}
+
+.unified-action-bar {
+  padding: var(--unified-shell-padding-y) var(--unified-shell-padding-x);
+  border-bottom: 1px solid var(--unified-shell-divider);
+  margin-bottom: 0 !important;
+}
+
+.ctms-page > .ctms-page-header.unified-action-bar,
+.page > .page-header.unified-action-bar {
+  border: 0;
+  border-radius: var(--unified-shell-radius);
+  background: #ffffff;
+  box-shadow: none;
+}
+
+.unified-section {
+  padding: var(--unified-shell-padding-y) var(--unified-shell-padding-x);
+  border-bottom: 1px solid var(--unified-shell-divider);
+}
+
+.unified-section:last-child {
+  border-bottom: 0;
+}
+
+.unified-section-header {
+  display: flex;
+  align-items: center;
+  justify-content: space-between;
+  gap: 12px;
+  margin-bottom: 10px;
+}
+
+.unified-shell .ctms-section-actions {
+  margin-left: auto;
+}
+
+.unified-action-bar .ctms-page-actions,
+.unified-action-bar .actions {
+  display: flex;
+  align-items: center;
+  gap: 8px;
+  margin-left: auto;
+}
+
+.unified-action-bar .ctms-page-title,
+.unified-action-bar .page-title {
+  margin: 0;
+  font-size: 20px;
+  font-weight: 700;
+  color: var(--unified-title-color);
+}
+
+.unified-action-bar .ctms-page-subtitle,
+.unified-action-bar .page-subtitle {
+  margin: 4px 0 0;
+  font-size: 13px;
+  color: var(--unified-muted-color);
+}
+
+.filter-container.unified-action-bar .filter-form,
+.filter-container.unified-action-bar .ctms-filter-row {
+  align-items: center;
+}
+
+.unified-shell .el-table th.el-table__cell {
+  background-color: #f8fbff;
+  color: #35527d;
+  font-weight: 600;
+  height: 42px;
+  font-size: 13px;
+}
+
+.unified-shell .el-table td.el-table__cell {
+  border-bottom-color: #edf2f8;
+  padding: 8px 0;
+}
+
+.unified-shell .el-button,
+.unified-action-bar .el-button {
+  border-radius: 10px;
+  height: 32px;
+  padding: 0 12px;
+  font-size: 13px;
+  font-weight: 600;
+}
+
+.unified-shell .el-tabs__nav-wrap::after {
+  background-color: #edf2f8;
+}
+
+.unified-shell .el-tabs__item {
+  font-weight: 600;
+}
+
+.unified-shell .el-form-item {
+  margin-bottom: 12px;
+}
+
+.unified-shell .el-form-item__label {
+  font-size: 13px;
+  font-weight: 600;
+  color: var(--unified-muted-color);
+}
+
+.unified-shell .filter-form,
+.unified-shell .ctms-filter-row {
+  margin: 0;
+}
+
+.unified-shell .ctms-table-card,
+.unified-shell .ctms-section-card,
+.unified-shell .detail-card,
+.unified-shell .section-card,
+.unified-shell .form-card {
+  margin-bottom: 0;
+  border: 0;
+  border-radius: 0;
+  box-shadow: none !important;
+}
+
+.unified-shell .ctms-table-card + .ctms-table-card,
+.unified-shell .ctms-section-card + .ctms-section-card,
+.unified-shell .detail-card + .section-card,
+.unified-shell .section-card + .section-card,
+.unified-shell .form-card + .form-card {
+  border-top: 1px solid var(--unified-shell-divider);
+}
+
+.unified-shell .ctms-section-title,
+.unified-shell .section-title,
+.unified-shell .header-title {
+  font-size: 15px;
+  font-weight: 700;
+  color: var(--unified-title-color);
+}
+
+.unified-shell .text-secondary,
+.unified-shell .info-label {
+  color: var(--unified-muted-color);
+}
+
+@media (max-width: 960px) {
+  .unified-action-bar,
+  .unified-section {
+    padding-left: 14px;
+    padding-right: 14px;
+  }
+}

frontend/src/types/api.ts

@@ -61,8 +61,26 @@ export interface Study {
   id: string;
   code: string;
   name: string;
+  project_full_name?: string | null;
   sponsor?: string | null;
   protocol_no?: string | null;
+  lead_unit?: string | null;
+  principal_investigator?: string | null;
+  main_pm?: string | null;
+  research_analysis?: string | null;
+  research_product?: string | null;
+  control_product?: string | null;
+  indication?: string | null;
+  research_population?: string | null;
+  research_design?: string | null;
+  plan_start_date?: string | null;
+  plan_end_date?: string | null;
+  planned_site_count?: number | null;
+  planned_enrollment_count?: number | null;
+  enrollment_monthly_goal_note?: string | null;
+  enrollment_stage_breakdown?: string | null;
+  summary_note?: string | null;
+  objective_note?: string | null;
   phase?: string | null;
   status: string;
   is_locked?: boolean;
@@ -92,6 +110,9 @@ export interface Site {
   pi_name?: string | null;
   contact?: string | null;
   enrollment_target?: number | null;
+  enrollment_plan_start_date?: string | null;
+  enrollment_plan_end_date?: string | null;
+  enrollment_plan_note?: string | null;
   is_active: boolean;
   created_at?: string;
 }

frontend/src/types/setupConfig.ts

@@ -0,0 +1,116 @@
+export interface ProjectMilestoneDraft {
+  id: string;
+  name: string;
+  planDate: string;
+  owner: string;
+  remark: string;
+  status: "未开始" | "进行中" | "已完成" | string;
+}
+
+export interface EnrollmentPlanDraft {
+  totalTarget: number;
+  startDate: string;
+  endDate: string;
+  monthlyGoalNote: string;
+  stageBreakdown: string;
+}
+
+export interface SiteMilestoneDraft {
+  id: string;
+  milestone: string;
+  planDate: string;
+  owner: string;
+  remark: string;
+  status: "未开始" | "进行中" | "已完成" | string;
+}
+
+export interface SiteEnrollmentPlanDraft {
+  id: string;
+  siteId: string;
+  siteName: string;
+  target: number;
+  startDate: string;
+  endDate: string;
+  note: string;
+  stageBreakdown: string;
+}
+
+export interface MonitoringStrategyDraft {
+  id: string;
+  strategyType: string;
+  detail: string;
+  frequency: string;
+  updatedAt: string;
+  enabled: boolean;
+}
+
+export interface CenterConfirmDraft {
+  id: string;
+  siteId: string;
+  siteName: string;
+  confirmer: string;
+  confirmStatus: "待确认" | "已确认" | "退回" | string;
+  confirmDate: string;
+  note: string;
+}
+
+export interface SetupConfigDraft {
+  projectMilestones: ProjectMilestoneDraft[];
+  enrollmentPlan: EnrollmentPlanDraft;
+  siteMilestones: SiteMilestoneDraft[];
+  siteEnrollmentPlans: SiteEnrollmentPlanDraft[];
+  monitoringStrategies: MonitoringStrategyDraft[];
+  centerConfirm: CenterConfirmDraft[];
+}
+
+export interface StudySetupConfigResponse {
+  id: string;
+  study_id: string;
+  version: number;
+  data: SetupConfigDraft;
+  publish_status: "DRAFT" | "PUBLISHED" | string;
+  published_data?: SetupConfigDraft | null;
+  published_by?: string | null;
+  published_by_name?: string | null;
+  published_at?: string | null;
+  saved_by?: string | null;
+  saved_by_name?: string | null;
+  projection_status?: "success" | "partial_success" | "failed" | string | null;
+  projection_summary?: {
+    study_updated?: boolean;
+    site_updated_count?: number;
+    site_skipped_count?: number;
+    warnings?: string[];
+    skipped_items?: Array<{ site_id: string; reason: string }>;
+  } | null;
+  created_at: string;
+  updated_at: string;
+}
+
+export interface StudySetupConfigUpsertPayload {
+  expected_version?: number | null;
+  data: SetupConfigDraft;
+}
+
+export interface StudySetupConfigPublishPayload {
+  expected_version?: number | null;
+}
+
+export interface StudySetupConfigRollbackPayload {
+  expected_version?: number | null;
+  target_version: number;
+}
+
+export interface StudySetupConfigVersionItem {
+  id: string;
+  study_id: string;
+  study_setup_config_id: string;
+  version: number;
+  display_version: number;
+  source_version?: number | null;
+  config: SetupConfigDraft;
+  published_by?: string | null;
+  published_by_name?: string | null;
+  published_at: string;
+  created_at: string;
+}

frontend/src/utils/setupDiffRows.ts

@@ -0,0 +1,155 @@
+import type { SetupConfigDraft } from "../types/setupConfig";
+
+export type SetupDiffRow = {
+  moduleLabel: string;
+  path: string;
+  changeType: "新增" | "删除" | "修改";
+  localValue: string;
+  serverValue: string;
+};
+
+export type SetupModuleLabel = {
+  key: keyof SetupConfigDraft;
+  label: string;
+};
+
+const setupFieldLabelMap: Record<keyof SetupConfigDraft, Record<string, string>> = {
+  projectMilestones: {
+    id: "ID",
+    name: "里程碑",
+    planDate: "计划日期",
+    owner: "负责人",
+    remark: "备注",
+    status: "状态",
+  },
+  enrollmentPlan: {
+    totalTarget: "计划总入组例数",
+    startDate: "计划开始日期",
+    endDate: "计划结束日期",
+    monthlyGoalNote: "月度目标说明",
+    stageBreakdown: "分阶段计划",
+  },
+  siteMilestones: {
+    id: "ID",
+    milestone: "里程碑",
+    planDate: "计划日期",
+    owner: "负责人",
+    remark: "备注",
+  },
+  siteEnrollmentPlans: {
+    id: "ID",
+    siteId: "中心ID",
+    siteName: "中心名称",
+    target: "计划例数",
+    startDate: "启动日期",
+    endDate: "完成日期",
+    note: "备注",
+    stageBreakdown: "分阶段计划",
+  },
+  monitoringStrategies: {
+    id: "ID",
+    strategyType: "监查类型",
+    detail: "策略详情",
+    frequency: "监查次数",
+    updatedAt: "更新时间",
+    enabled: "是否启用",
+  },
+  centerConfirm: {
+    id: "ID",
+    siteId: "中心ID",
+    siteName: "中心名称",
+    confirmer: "确认人",
+    confirmStatus: "确认状态",
+    confirmDate: "确认日期",
+    note: "备注",
+  },
+};
+
+const formatReadablePath = (moduleKey: keyof SetupConfigDraft, path: string): string => {
+  const normalized = path.startsWith(`${moduleKey}.`) ? path.slice(moduleKey.length + 1) : path;
+  if (!normalized || normalized === moduleKey) return "根节点";
+  const parts = normalized.split(".");
+  const labels = parts.map((part, idx) => {
+    const match = part.match(/^([^\[]+)\[(\d+)\]$/);
+    if (match) {
+      const fieldKey = match[1];
+      const rowNo = Number(match[2]) + 1;
+      const label = setupFieldLabelMap[moduleKey][fieldKey] || fieldKey;
+      return idx === 0 ? `${label} 第${rowNo}行` : `第${rowNo}行`;
+    }
+    return setupFieldLabelMap[moduleKey][part] || part;
+  });
+  return labels.join(" / ");
+};
+
+export const serializeDiffValue = (value: unknown): string => {
+  if (value === null || value === undefined) return "-";
+  if (typeof value === "string") return value || '""';
+  if (typeof value === "number" || typeof value === "boolean") return String(value);
+  return JSON.stringify(value);
+};
+
+const isPlainObject = (value: unknown): value is Record<string, unknown> =>
+  Boolean(value) && typeof value === "object" && !Array.isArray(value);
+
+const collectDiffRows = (
+  moduleLabel: string,
+  localValue: unknown,
+  serverValue: unknown,
+  path: string,
+  rows: SetupDiffRow[]
+) => {
+  if (Array.isArray(localValue) || Array.isArray(serverValue)) {
+    const localArr = Array.isArray(localValue) ? localValue : [];
+    const serverArr = Array.isArray(serverValue) ? serverValue : [];
+    const maxLen = Math.max(localArr.length, serverArr.length);
+    for (let i = 0; i < maxLen; i += 1) {
+      collectDiffRows(moduleLabel, localArr[i], serverArr[i], `${path}[${i}]`, rows);
+    }
+    return;
+  }
+
+  if (isPlainObject(localValue) || isPlainObject(serverValue)) {
+    const localObj = isPlainObject(localValue) ? localValue : {};
+    const serverObj = isPlainObject(serverValue) ? serverValue : {};
+    const keys = Array.from(new Set([...Object.keys(localObj), ...Object.keys(serverObj)]));
+    keys.forEach((key) => {
+      const childPath = path ? `${path}.${key}` : key;
+      collectDiffRows(moduleLabel, localObj[key], serverObj[key], childPath, rows);
+    });
+    return;
+  }
+
+  if (localValue === serverValue) return;
+  const hasLocal = localValue !== undefined;
+  const hasServer = serverValue !== undefined;
+  const changeType: SetupDiffRow["changeType"] = hasLocal && hasServer ? "修改" : hasLocal ? "新增" : "删除";
+  rows.push({
+    moduleLabel,
+    path: path || "(root)",
+    changeType,
+    localValue: serializeDiffValue(localValue),
+    serverValue: serializeDiffValue(serverValue),
+  });
+};
+
+export const buildSetupReadableDiffRows = (
+  localDraft: SetupConfigDraft | null,
+  serverDraft: SetupConfigDraft | null,
+  moduleLabels: SetupModuleLabel[],
+  limit = 300
+): SetupDiffRow[] => {
+  if (!localDraft || !serverDraft) return [];
+  const rows: SetupDiffRow[] = [];
+  moduleLabels.forEach((item) => {
+    collectDiffRows(item.label, localDraft[item.key], serverDraft[item.key], String(item.key), rows);
+  });
+  return rows.slice(0, limit).map((row) => {
+    const moduleKey = moduleLabels.find((item) => item.label === row.moduleLabel)?.key;
+    if (!moduleKey) return row;
+    return {
+      ...row,
+      path: formatReadablePath(moduleKey, row.path),
+    };
+  });
+};

frontend/src/utils/setupFieldLocator.ts

@@ -0,0 +1,33 @@
+export type SetupValidationError = {
+  field: string;
+  message: string;
+};
+
+export type ParsedFieldPath = {
+  section: string;
+  index: number;
+  field: string;
+};
+
+export const parseFieldPath = (path: string): ParsedFieldPath | null => {
+  const matched = path.match(/^([a-zA-Z0-9_]+)\[(\d+)\]\.([a-zA-Z0-9_]+)$/);
+  if (!matched) return null;
+  return {
+    section: matched[1],
+    index: Number(matched[2]),
+    field: matched[3],
+  };
+};
+
+export const groupErrorsBySection = (errors: SetupValidationError[]): Record<string, SetupValidationError[]> => {
+  const grouped: Record<string, SetupValidationError[]> = {};
+  errors.forEach((error) => {
+    const parsed = parseFieldPath(error.field);
+    const section = parsed?.section || error.field.split(".")[0] || "global";
+    if (!grouped[section]) {
+      grouped[section] = [];
+    }
+    grouped[section].push(error);
+  });
+  return grouped;
+};

frontend/src/views/Faq.vue

@@ -9,8 +9,8 @@
         />
       </el-col>
       <el-col :span="19">
-        <el-card class="mb-12">
-          <div class="filters">
+        <div class="faq-main unified-shell">
+          <div class="filters unified-action-bar">
             <el-input
               v-model="keyword"
               :placeholder="TEXT.common.placeholders.keyword"
@@ -24,7 +24,6 @@
               <el-button type="primary" @click="openForm()">{{ TEXT.modules.knowledgeMedicalConsult.newItem }}</el-button>
             </PermissionAction>
           </div>
-        </el-card>
 
           <FaqList
             :items="faqs"
@@ -41,6 +40,7 @@
             :total="total"
             @current-change="onPageChange"
           />
+        </div>
       </el-col>
     </el-row>
 
@@ -146,10 +146,17 @@ onMounted(async () => {
 .page {
   padding: 16px;
 }
+.faq-main {
+  background: #fff;
+  border: 1px solid var(--ctms-border-color);
+  border-radius: 10px;
+  padding: 16px;
+}
 .filters {
   display: flex;
   gap: 8px;
   align-items: center;
+  margin-bottom: 16px;
 }
 .spacer {
   flex: 1;
@@ -158,7 +165,4 @@ onMounted(async () => {
   margin-top: 12px;
   text-align: right;
 }
-.mb-12 {
-  margin-bottom: 12px;
-}
 </style>

frontend/src/views/FaqDetail.vue

@@ -1,6 +1,6 @@
 <template>
-  <div class="page">
-    <el-card v-loading="loading">
+  <div class="page unified-shell">
+    <el-card class="unified-shell" v-loading="loading">
       <div class="content">
         <div class="question-header">
           <div class="question-label">{{ TEXT.modules.knowledgeMedicalConsult.questionDesc }}</div>
@@ -36,7 +36,7 @@
       </div>
     </el-card>
 
-    <el-card class="mt-12" v-loading="repliesLoading">
+    <el-card class="mt-12 unified-shell" v-loading="repliesLoading">
       <template #header>
         <div class="reply-header">
           <span>{{ TEXT.modules.knowledgeMedicalConsult.replies }}</span>

frontend/src/views/Login.vue

@@ -118,6 +118,7 @@ import { useAuthStore } from "../store/auth";
 import { useStudyStore } from "../store/study";
 import { getCachedCredential, setCachedCredential, clearCachedCredential } from "../utils/auth";
 import { TEXT, requiredMessage } from "../locales";
+import { consumeLogoutReason, LOGOUT_REASON_TIMEOUT } from "../session/sessionManager";
 
 const auth = useAuthStore();
 const router = useRouter();
@@ -143,6 +144,10 @@ let vantaEffect: any = null;
 
 // 初始化 Vanta.js 效果
 onMounted(() => {
+  const logoutReason = consumeLogoutReason();
+  if (logoutReason === LOGOUT_REASON_TIMEOUT) {
+    ElMessage.warning("长时间未操作，已自动退出登录，请重新登录");
+  }
   const cached = getCachedCredential();
   if (cached) {
     form.email = cached.email;
@@ -228,8 +233,13 @@ const onSubmit = async () => {
       router.push("/");
     }
   } catch (error: any) {
+    const status = error?.response?.status;
     const detail = error?.response?.data?.detail || error?.response?.data?.message;
+    if (!status || status >= 500) {
+      ElMessage.error("服务暂时不可用，请稍后重试");
+    } else {
       ElMessage.error(detail || TEXT.modules.auth.authFailed);
+    }
   } finally {
     loading.value = false;
   }

frontend/src/views/ProfileSettings.vue

@@ -1,6 +1,6 @@
 <template>
   <div class="page">
-    <el-card>
+    <el-card class="unified-shell">
       <h3 class="title">{{ TEXT.modules.profile.title }}</h3>
       <p class="subtitle">{{ TEXT.modules.profile.subtitle }}</p>
       <el-form ref="formRef" :model="form" :rules="rules" label-width="120px" class="form">

frontend/src/views/StudyHome.vue

@@ -1,5 +1,5 @@
 <template>
-  <div class="study-home-container" v-if="study.currentStudy">
+  <div class="study-home-container unified-shell" v-if="study.currentStudy">
     <!-- 概览头部 -->
     <div class="home-header">
       <div class="header-content">
@@ -68,7 +68,7 @@
     />
 
     <!-- 通知 -->
-    <el-card class="notifications-card">
+    <el-card class="notifications-card unified-shell">
       <div class="notifications-header">
         <span class="notifications-title">{{ TEXT.modules.projectOverview.notificationsTitle }}</span>
         <span class="notifications-subtitle">{{ TEXT.modules.projectOverview.notificationsSubtitle }}</span>

frontend/src/views/admin/AdminUserApproval.vue

@@ -1,7 +1,7 @@
 <template>
   <div class="page">
-    <el-card shadow="never" class="main-content-card">
-      <div class="filter-container">
+    <el-card shadow="never" class="main-content-card unified-shell">
+      <div class="filter-container unified-action-bar">
         <div class="filter-form">
           <el-tag type="info" effect="plain" class="filter-label-tag">{{ TEXT.common.fields.status }}</el-tag>
           <el-select v-model="status" style="width: 140px" @change="loadUsers" class="filter-select-comp">
@@ -13,6 +13,7 @@
           <div class="filter-spacer"></div>
         </div>
       </div>
+      <div class="unified-section approval-table-section">
         <el-table :data="users" v-loading="loading" style="width: 100%">
           <el-table-column prop="email" :label="TEXT.common.fields.email" min-width="200" />
           <el-table-column prop="full_name" :label="TEXT.common.fields.name" min-width="140" />
@@ -52,6 +53,7 @@
             </template>
           </el-table-column>
         </el-table>
+      </div>
     </el-card>
   </div>
 </template>
@@ -124,14 +126,6 @@ onMounted(() => {
   flex-direction: column;
 }
 
-.main-content-card :deep(.el-card__body) {
-  padding: 20px;
-}
-
-.filter-container {
-  margin-bottom: 20px;
-}
-
 .filter-form {
   display: flex;
   width: 100%;
@@ -150,4 +144,9 @@ onMounted(() => {
 .filter-spacer {
   flex: 1;
 }
+
+.approval-table-section {
+  padding-top: 12px;
+  padding-bottom: 12px;
+}
 </style>

frontend/src/views/admin/AuditLogs.vue

@@ -1,8 +1,13 @@
 <template>
   <div class="page">
-    <el-card shadow="never" class="main-content-card">
-      <div class="filter-container">
+    <el-card shadow="never" class="main-content-card unified-shell">
+      <div class="filter-container unified-action-bar">
         <el-form :inline="true" :model="filters" class="filter-form">
+          <el-form-item label="" class="filter-item-form">
+            <el-select v-model="filters.entityType" clearable :placeholder="TEXT.modules.adminAuditLogs.filterEntityType" @change="loadLogs" class="filter-select-comp">
+              <el-option v-for="opt in entityTypeOptions" :key="opt.value" :label="opt.label" :value="opt.value" />
+            </el-select>
+          </el-form-item>
           <el-form-item label="" class="filter-item-form">
             <el-select v-model="filters.eventType" clearable :placeholder="TEXT.modules.adminAuditLogs.filterEvent" @change="loadLogs" class="filter-select-comp">
               <el-option v-for="opt in eventTypeOptions" :key="opt.value" :label="opt.label" :value="opt.value" />
@@ -43,6 +48,7 @@
           </div>
         </el-form>
       </div>
+      <div class="unified-section table-section">
         <el-table :data="logs" v-loading="loading" style="width: 100%" stripe>
           <el-table-column prop="timestamp" :label="TEXT.modules.adminAuditLogs.columns.time" width="180" align="center">
             <template #default="scope">
@@ -90,6 +96,7 @@
           :total="total"
           @current-change="onPageChange"
         />
+      </div>
     </el-card>
   </div>
 </template>
@@ -141,6 +148,7 @@ const pageSize = 20;
 const total = ref(0);
 
 const filters = ref({
+  entityType: "",
   eventType: "",
   operatorId: "",
   result: "",
@@ -151,6 +159,15 @@ const eventTypeOptions = Object.entries(auditDict).map(([value, cfg]) => ({
   value,
   label: cfg.label,
 }));
+const entityTypeOptions = [
+  { value: "study_setup_config", label: "立项配置" },
+  { value: "study", label: "项目" },
+  { value: "subject", label: "参与者" },
+  { value: "site", label: "中心" },
+  { value: "finance", label: "费用" },
+  { value: "drug_shipment", label: "药品流向" },
+  { value: "audit_log", label: "审计日志" },
+];
 const userOptions = computed(() => users.value.map((u: any) => ({ label: u.username, value: u.id })));
 const isAdmin = computed(() => auth.user?.role === "ADMIN");
 const canProjectExport = computed(() => !!study.currentStudy && auth.user?.role === "ADMIN");
@@ -188,6 +205,7 @@ const loadLogs = async () => {
     const params: Record<string, any> = {
       skip: (page.value - 1) * pageSize,
       limit: pageSize,
+      entity_type: filters.value.entityType || undefined,
       action: filters.value.eventType || undefined,
       operator_id: filters.value.operatorId || undefined,
     };
@@ -258,6 +276,7 @@ const fetchAllForExport = async () => {
     const params: Record<string, any> = {
       skip: 0,
       limit: 2000,
+      entity_type: filters.value.entityType || undefined,
       action: filters.value.eventType || undefined,
       operator_id: filters.value.operatorId || undefined,
     };
@@ -327,12 +346,9 @@ onMounted(async () => {
   flex-direction: column;
 }
 
-.main-content-card :deep(.el-card__body) {
-  padding: 20px;
-}
-
-.filter-container {
-  margin-bottom: 20px;
+.table-section {
+  padding-top: 12px;
+  padding-bottom: 12px;
 }
 
 .filter-form {

frontend/src/views/admin/ProjectForm.vue

@@ -20,19 +20,6 @@
           <el-option :label="TEXT.enums.projectStatus.CLOSED" value="CLOSED" />
         </el-select>
       </el-form-item>
-      <el-divider content-position="left">{{ TEXT.modules.adminProjects.visitTemplate }}</el-divider>
-      <el-form-item :label="TEXT.common.fields.visitTotal">
-        <el-input-number v-model="form.visit_total" :min="1" :max="50" :step="1" />
-      </el-form-item>
-      <el-form-item :label="TEXT.common.fields.visitIntervalDays">
-        <el-input-number v-model="form.visit_interval_days" :min="1" :max="365" :step="1" />
-      </el-form-item>
-      <el-form-item :label="TEXT.common.fields.visitWindowStartOffset">
-        <el-input-number v-model="form.visit_window_start_offset" :min="-365" :max="365" :step="1" />
-      </el-form-item>
-      <el-form-item :label="TEXT.common.fields.visitWindowEndOffset">
-        <el-input-number v-model="form.visit_window_end_offset" :min="-365" :max="365" :step="1" />
-      </el-form-item>
     </el-form>
     <template #footer>
       <el-button @click="visibleProxy = false">{{ TEXT.common.actions.cancel }}</el-button>
@@ -71,14 +58,11 @@ const form = reactive({
   protocol_no: "",
   phase: "",
   status: "DRAFT",
-  visit_interval_days: null as number | null,
-  visit_total: null as number | null,
-  visit_window_start_offset: null as number | null,
-  visit_window_end_offset: null as number | null,
 });
 
 const rules = reactive<FormRules>({
   name: [{ required: true, message: requiredMessage(TEXT.common.fields.projectName), trigger: "blur" }],
+  code: [{ required: true, message: requiredMessage(TEXT.common.fields.projectCode), trigger: "blur" }],
   status: [{ required: true, message: requiredMessage(TEXT.common.fields.status), trigger: "change" }],
 });
 
@@ -88,10 +72,6 @@ const resetForm = () => {
   form.protocol_no = "";
   form.phase = "";
   form.status = "DRAFT";
-  form.visit_interval_days = null;
-  form.visit_total = null;
-  form.visit_window_start_offset = null;
-  form.visit_window_end_offset = null;
 };
 
 watch(
@@ -105,10 +85,6 @@ watch(
         form.protocol_no = props.project.protocol_no || "";
         form.phase = props.project.phase || "";
         form.status = props.project.status || "DRAFT";
-        form.visit_interval_days = props.project.visit_interval_days ?? null;
-        form.visit_total = props.project.visit_total ?? null;
-        form.visit_window_start_offset = props.project.visit_window_start_offset ?? null;
-        form.visit_window_end_offset = props.project.visit_window_end_offset ?? null;
       }
     }
   }
@@ -122,27 +98,19 @@ const onSubmit = async () => {
     if (props.project) {
       await updateStudy(props.project.id, {
         name: form.name,
-        code: form.code,
+        code: form.code.trim(),
         protocol_no: form.protocol_no,
         phase: form.phase,
         status: form.status,
-        visit_interval_days: form.visit_interval_days,
-        visit_total: form.visit_total,
-        visit_window_start_offset: form.visit_window_start_offset,
-        visit_window_end_offset: form.visit_window_end_offset,
       });
       ElMessage.success(TEXT.modules.adminProjects.updateSuccess);
     } else {
       await createStudy({
         name: form.name,
-        code: form.code,
+        code: form.code.trim(),
         protocol_no: form.protocol_no,
         phase: form.phase,
         status: form.status,
-        visit_interval_days: form.visit_interval_days,
-        visit_total: form.visit_total,
-        visit_window_start_offset: form.visit_window_start_offset,
-        visit_window_end_offset: form.visit_window_end_offset,
       });
       ElMessage.success(TEXT.modules.adminProjects.createSuccess);
     }

frontend/src/views/admin/ProjectMembers.vue

@@ -1,14 +1,13 @@
 <template>
   <div class="page">
-    <el-card shadow="never" class="main-content-card">
-      <div class="filter-container">
-        <div class="filter-form">
+    <el-card shadow="never" class="main-content-card unified-shell">
+      <div class="unified-action-bar actions-only-bar">
         <div class="filter-spacer"></div>
-          <el-button type="primary" @click="openAdd" class="header-action-btn">
+        <el-button type="primary" @click="openAdd">
           {{ TEXT.common.actions.add }}{{ TEXT.modules.adminProjectMembers.memberLabel }}
         </el-button>
       </div>
-      </div>
+      <div class="unified-section member-table-section">
         <el-table :data="memberRows" v-loading="loading" stripe>
           <el-table-column prop="full_name" :label="TEXT.modules.adminProjectMembers.username" min-width="160" />
           <el-table-column prop="role_in_study" :label="TEXT.modules.adminProjectMembers.projectRole" min-width="140">
@@ -62,6 +61,7 @@
             </template>
           </el-table-column>
         </el-table>
+      </div>
     </el-card>
 
     <el-dialog :title="TEXT.modules.adminProjectMembers.newTitle" width="520px" v-model="addVisible" :close-on-click-modal="false">
@@ -399,29 +399,15 @@ onMounted(async () => {
   flex-direction: column;
 }
 
-.main-content-card :deep(.el-card__body) {
-  padding: 20px;
-}
-
-.filter-container {
-  margin-bottom: 20px;
-}
-
-.filter-form {
+.actions-only-bar {
   display: flex;
-  width: 100%;
-  gap: 12px;
+  justify-content: flex-end;
   align-items: center;
 }
 
-.filter-spacer {
-  flex: 1;
-}
-
-.header-action-btn {
-  height: 36px;
-  padding: 0 20px;
-  border-radius: 8px;
+.member-table-section {
+  padding-top: 12px;
+  padding-bottom: 12px;
 }
 
 .hint {

frontend/src/views/admin/Projects.vue

@@ -1,14 +1,13 @@
 <template>
   <div class="page">
-    <el-card shadow="never" class="main-content-card">
-      <div class="filter-container">
-        <div class="filter-form">
+    <el-card shadow="never" class="main-content-card unified-shell">
+      <div class="unified-action-bar actions-only-bar">
         <div class="filter-spacer"></div>
-          <el-button type="primary" @click="openCreate" class="header-action-btn">
+        <el-button type="primary" @click="openCreate">
           {{ TEXT.common.actions.add }}{{ TEXT.modules.adminProjects.projectLabel }}
         </el-button>
       </div>
-      </div>
+      <div class="unified-section">
         <el-table :data="projects" v-loading="loading" stripe>
           <el-table-column prop="name" :label="TEXT.common.fields.projectName" min-width="300">
             <template #default="scope">
@@ -57,6 +56,7 @@
             </template>
           </el-table-column>
         </el-table>
+      </div>
     </el-card>
     <ProjectForm v-model:visible="formVisible" :project="editingProject" @saved="loadProjects" />
   </div>
@@ -197,7 +197,7 @@ const enterStudy = (row: Study) => {
 };
 
 const goDetail = (row: Study) => {
-  router.push(`/projects/${row.id}`);
+  router.push(`/admin/projects/${row.id}`);
 };
 
 const statusLabel = (status: string) =>
@@ -221,52 +221,19 @@ onMounted(() => {
   flex-direction: column;
 }
 
-.main-content-card :deep(.el-card__body) {
-  padding: 20px;
-}
-
-.filter-container {
-  margin-bottom: 20px;
-}
-
-.filter-form {
+.actions-only-bar {
   display: flex;
-  width: 100%;
-  gap: 12px;
+  justify-content: flex-end;
   align-items: center;
 }
 
-.filter-spacer {
-  flex: 1;
+.unified-section {
+  padding-top: 12px;
+  padding-bottom: 12px;
 }
 
-.header-action-btn {
-  height: 36px;
-  padding: 0 20px;
-  border-radius: 8px;
-}
-
-/* 表格样式美化 */
-:deep(.el-table) {
-  --el-table-header-bg-color: #f9fafb;
-  --el-table-header-text-color: #374151;
-  border-radius: 8px;
-  overflow: hidden;
-}
-
-:deep(.el-table th.el-table__cell) {
-  background-color: #f9fafb;
-  font-weight: 600;
-  height: 44px;
-}
-
-:deep(.el-table .el-table__cell) {
-  padding: 8px 0;
-}
-
-/* 操作按钮美化 */
 .action-btn {
-  font-size: 18px; /* 图标变更大 */
+  font-size: 18px;
   padding: 4px;
   margin: 0 2px;
   transition: all 0.3s;

frontend/src/views/admin/SiteForm.vue

@@ -28,9 +28,6 @@
           />
         </el-select>
       </el-form-item>
-      <el-form-item label="入组目标" prop="enrollment_target">
-        <el-input-number v-model="form.enrollment_target" :min="0" :step="1" :placeholder="'请输入入组目标人数'" />
-      </el-form-item>
     </el-form>
     <template #footer>
       <el-button @click="visibleProxy = false">{{ TEXT.common.actions.cancel }}</el-button>
@@ -77,7 +74,6 @@ const form = reactive({
   phone: "",
   contact: "",
   craSelections: [] as string[],
-  enrollment_target: 0,
   is_active: true,
 });
 
@@ -103,7 +99,6 @@ const resetForm = () => {
   form.phone = "";
   form.contact = "";
   form.craSelections = [];
-  form.enrollment_target = 0;
   form.is_active = true;
 };
 
@@ -127,7 +122,6 @@ watch(
           optionByLabel[opt.label] = opt.value;
         });
         form.craSelections = rawSelections.map((s) => optionByLabel[s] || s);
-        form.enrollment_target = (props.site as any)?.enrollment_target || 0;
         form.is_active = props.site.is_active;
       }
     }
@@ -161,7 +155,6 @@ const onSubmit = async () => {
         city: form.city,
         pi_name: form.pi_name,
         contact,
-        enrollment_target: form.enrollment_target,
         is_active: form.is_active,
       });
       ElMessage.success(TEXT.modules.adminSites.updateSuccess);
@@ -177,7 +170,6 @@ const onSubmit = async () => {
         city: form.city,
         pi_name: form.pi_name,
         contact,
-        enrollment_target: form.enrollment_target,
       });
       ElMessage.success(TEXT.modules.adminSites.createSuccess);
       logAudit("SITE_STATUS_CHANGED", {
@@ -187,6 +179,7 @@ const onSubmit = async () => {
         severity: "normal",
       });
     }
+
     emit("saved");
     visibleProxy.value = false;
   } catch (e: any) {

frontend/src/views/admin/Sites.vue

@@ -1,16 +1,24 @@
 <template>
   <div class="page">
-    <el-card shadow="never" class="main-content-card">
-      <div class="filter-container">
-        <div class="filter-form">
+    <el-card shadow="never" class="main-content-card unified-shell">
+      <div class="unified-action-bar actions-only-bar">
         <div class="filter-spacer"></div>
-          <el-button type="primary" @click="openCreate" class="header-action-btn">
+        <el-button type="primary" @click="openCreate">
           {{ TEXT.common.actions.add }}{{ TEXT.modules.adminSites.siteLabel }}
         </el-button>
       </div>
+      <div class="unified-section site-table-section">
+        <el-table :data="displaySites" v-loading="loading" stripe :row-class-name="siteRowClass">
+          <el-table-column prop="name" :label="TEXT.common.fields.siteName" width="220">
+            <template #default="scope">
+              <div class="site-name-cell">
+                <span>{{ scope.row.name }}</span>
+                <el-tag v-if="isLeadUnitSite(scope.row)" type="warning" effect="light" size="small">
+                  {{ TEXT.modules.adminSites.leadUnitTag }}
+                </el-tag>
               </div>
-      <el-table :data="sites" v-loading="loading" stripe :row-class-name="siteRowClass">
-        <el-table-column prop="name" :label="TEXT.common.fields.siteName" width="180" />
+            </template>
+          </el-table-column>
           <el-table-column prop="city" :label="TEXT.common.fields.city" width="100" />
           <el-table-column prop="pi_name" :label="TEXT.modules.adminSites.piLabel" width="120" />
           <el-table-column :label="TEXT.common.fields.phone" width="140">
@@ -52,6 +60,7 @@
             </template>
           </el-table-column>
         </el-table>
+      </div>
     </el-card>
     <SiteForm
       v-if="projectId"
@@ -158,7 +167,32 @@ const contactLabel = (row: any) => {
 
 const phoneText = (row: any) => row?.phone || row?.contact_phone || TEXT.common.fallback;
 
-const siteRowClass = ({ row }: { row: Site }) => (row.is_active ? "" : "row-inactive");
+const normalizeSiteName = (value?: string | null) => String(value || "").trim().replace(/\s+/g, "").toLowerCase();
+const isLeadUnitSite = (row: Site): boolean => {
+  const leadUnitName = normalizeSiteName(project.value?.lead_unit);
+  const siteName = normalizeSiteName(row.name);
+  if (!leadUnitName || !siteName) return false;
+  return siteName === leadUnitName;
+};
+
+const displaySites = computed(() => {
+  return sites.value
+    .map((item, index) => ({ item, index }))
+    .sort((a, b) => {
+      const aLead = isLeadUnitSite(a.item) ? 1 : 0;
+      const bLead = isLeadUnitSite(b.item) ? 1 : 0;
+      if (aLead !== bLead) return bLead - aLead;
+      return a.index - b.index;
+    })
+    .map((entry) => entry.item);
+});
+
+const siteRowClass = ({ row }: { row: Site }) => {
+  const classes: string[] = [];
+  if (!row.is_active) classes.push("row-inactive");
+  if (isLeadUnitSite(row)) classes.push("row-lead-unit");
+  return classes.join(" ");
+};
 
 const openCreate = () => {
   loadUsers();
@@ -271,29 +305,21 @@ onMounted(async () => {
   flex-direction: column;
 }
 
-.main-content-card :deep(.el-card__body) {
-  padding: 20px;
-}
-
-.filter-container {
-  margin-bottom: 20px;
-}
-
-.filter-form {
+.actions-only-bar {
   display: flex;
-  width: 100%;
-  gap: 12px;
+  justify-content: flex-end;
   align-items: center;
 }
 
-.filter-spacer {
-  flex: 1;
+.site-table-section {
+  padding-top: 12px;
+  padding-bottom: 12px;
 }
 
-.header-action-btn {
-  height: 36px;
-  padding: 0 20px;
-  border-radius: 8px;
+.site-name-cell {
+  display: inline-flex;
+  align-items: center;
+  gap: 8px;
 }
 
 </style>
@@ -308,6 +334,14 @@ onMounted(async () => {
   opacity: 0.6;
 }
 
+.row-lead-unit td {
+  background-color: #f3f8ff !important;
+}
+
+.row-lead-unit.row-inactive td {
+  background-color: #edf2fb !important;
+}
+
 .el-table .action-column .cell {
   padding-left: 8px;
   padding-right: 8px;

frontend/src/views/admin/Users.vue

@@ -1,7 +1,7 @@
 <template>
   <div class="page">
-    <el-card shadow="never" class="main-content-card">
-      <div class="filter-container">
+    <el-card shadow="never" class="main-content-card unified-shell">
+      <div class="filter-container unified-action-bar">
         <div class="filter-form">
           <el-form-item label="" class="filter-item-form">
             <el-input 
@@ -23,10 +23,11 @@
             <el-button @click="loadUsers">{{ TEXT.common.actions.search }}</el-button>
           </el-form-item>
           <div class="filter-spacer"></div>
-          <el-button type="primary" @click="openCreate" class="header-action-btn">{{ TEXT.common.actions.add }}{{ TEXT.modules.adminUsers.userLabel }}</el-button>
+          <el-button type="primary" @click="openCreate">{{ TEXT.common.actions.add }}{{ TEXT.modules.adminUsers.userLabel }}</el-button>
         </div>
       </div>
 
+      <div class="unified-section user-table-section">
         <el-table :data="users" stripe v-loading="loading" style="width: 100%">
           <el-table-column prop="email" :label="TEXT.common.fields.email" min-width="200" />
           <el-table-column prop="full_name" :label="TEXT.common.fields.name" min-width="140" />
@@ -79,6 +80,7 @@
           @current-change="loadUsers"
           class="pagination"
         />
+      </div>
     </el-card>
     <UserForm v-model:visible="formVisible" :user="editingUser" :admin-count="activeAdminCount" @saved="loadUsers" />
     <UserResetPassword v-model:visible="resetVisible" :user="resetUser" @reset="loadUsers" />
@@ -282,14 +284,6 @@ onMounted(() => {
   flex-direction: column;
 }
 
-.main-content-card :deep(.el-card__body) {
-  padding: 20px;
-}
-
-.filter-container {
-  margin-bottom: 20px;
-}
-
 .filter-form {
   display: flex;
   width: 100%;
@@ -310,10 +304,9 @@ onMounted(() => {
   flex: 1;
 }
 
-.header-action-btn {
-  height: 36px;
-  padding: 0 20px;
-  border-radius: 8px;
+.user-table-section {
+  padding-top: 12px;
+  padding-bottom: 12px;
 }
 
 .pagination {

frontend/src/views/documents/DocumentDetail.vue

@@ -1,11 +1,13 @@
 <template>
-  <div class="ctms-page">
-    <div class="ctms-page-header">
+  <div class="page">
+    <div class="unified-shell">
+      <section class="unified-section" v-loading="loading">
+        <div class="unified-section-header">
           <div>
-        <h1 class="ctms-page-title">
+            <div class="ctms-section-title">
               {{ detail.title || TEXT.modules.fileVersionManagement.title }}
-        </h1>
-        <p class="ctms-page-subtitle">
+            </div>
+            <div class="doc-meta-row mt-1">
               <el-tag size="small" effect="plain" type="info" class="mr-2">{{ displayText(detail.doc_type, TEXT.enums.documentType) }}</el-tag>
               <el-tag size="small" effect="plain" type="warning" class="mr-2">{{ displaySite(detail.site_id) }}</el-tag>
               <el-tag v-if="isReadOnly" size="small" effect="plain" type="info">中心已停用</el-tag>
@@ -13,17 +15,15 @@
                 {{ TEXT.modules.fileVersionManagement.labels.currentEffective }}：
                 <span class="font-medium text-main">{{ detail.current_effective_version?.version_no || TEXT.common.fallback }}</span>
               </span>
-        </p>
             </div>
-      <div class="ctms-page-actions">
+          </div>
+          <div class="ctms-section-actions">
             <el-button @click="goBack">
               <el-icon class="el-icon--left"><ArrowLeft /></el-icon>
               {{ TEXT.common.actions.back }}
             </el-button>
           </div>
         </div>
-
-    <el-card class="ctms-section-card" v-loading="loading">
         <el-descriptions :column="3" border class="ctms-descriptions">
           <el-descriptions-item :label="TEXT.modules.fileVersionManagement.fields.docType">{{ displayText(detail.doc_type, TEXT.enums.documentType) }}</el-descriptions-item>
           <el-descriptions-item :label="TEXT.modules.fileVersionManagement.fields.site">{{ displaySite(detail.site_id) }}</el-descriptions-item>
@@ -35,8 +35,9 @@
           </el-descriptions-item>
           <el-descriptions-item :label="TEXT.modules.fileVersionManagement.columns.updatedAt">{{ formatDate(detail.updated_at) }}</el-descriptions-item>
         </el-descriptions>
-    </el-card>
+      </section>
 
+      <section class="unified-section">
         <el-tabs v-model="activeTab" @tab-change="handleTabChange" class="ctms-tabs">
       <el-tab-pane :label="TEXT.modules.fileVersionManagement.tabs.versions" name="versions">
         <div class="ctms-section-header">
@@ -48,7 +49,7 @@
             </el-button>
           </div>
         </div>
-        <el-card class="ctms-table-card">
+        <el-card class="ctms-table-card unified-shell">
           <el-table :data="detail.version_timeline" v-loading="versionLoading" class="ctms-table">
             <el-table-column prop="version_no" :label="TEXT.modules.fileVersionManagement.fields.versionNo" width="120">
                <template #default="{ row }">
@@ -106,7 +107,7 @@
             </el-button>
           </div>
         </div>
-        <el-card class="ctms-table-card">
+        <el-card class="ctms-table-card unified-shell">
           <el-table :data="distributions" v-loading="distributionLoading" class="ctms-table">
             <el-table-column :label="TEXT.modules.fileVersionManagement.fields.targetType" width="120">
               <template #default="{ row }">
@@ -128,6 +129,8 @@
       </el-tab-pane>
 
         </el-tabs>
+      </section>
+    </div>
 
     <el-dialog v-model="uploadVisible" :title="TEXT.modules.fileVersionManagement.dialog.uploadTitle" width="520px" destroy-on-close class="ctms-dialog">
       <el-form ref="uploadFormRef" :model="uploadForm" :rules="uploadRules" label-width="110px" class="ctms-form">
@@ -671,6 +674,19 @@ watch(
 </script>
 
 <style scoped>
+.page {
+  display: flex;
+  flex-direction: column;
+  gap: 0;
+}
+
+.doc-meta-row {
+  display: flex;
+  align-items: center;
+  flex-wrap: wrap;
+  gap: 8px;
+}
+
 .text-secondary {
   color: var(--ctms-text-secondary);
 }

frontend/src/views/documents/DocumentList.vue

@@ -1,8 +1,7 @@
 <template>
-  <div class="ctms-page">
-
-    <el-card shadow="never" class="main-content-card">
-      <div class="filter-container">
+  <div class="page">
+    <el-card shadow="never" class="main-content-card unified-shell">
+      <div class="filter-container unified-action-bar">
         <el-form :inline="true" :model="filters" class="filter-form">
           <el-form-item label="" class="filter-item-form">
             <el-select v-model="filters.scope_type" :placeholder="TEXT.modules.fileVersionManagement.filters.scope" clearable class="filter-select-comp">
@@ -29,6 +28,7 @@
           </el-button>
         </el-form>
       </div>
+      <section class="unified-section">
         <el-table
           :data="sortedItems"
           v-loading="loading"
@@ -83,6 +83,7 @@
             <el-empty :description="TEXT.modules.fileVersionManagement.emptyDescription" />
           </template>
         </el-table>
+      </section>
     </el-card>
 
     <el-dialog v-model="createVisible" :title="TEXT.modules.fileVersionManagement.dialog.createTitle" width="520px" destroy-on-close class="ctms-dialog">
@@ -339,17 +340,18 @@ watch(
 </script>
 
 <style scoped>
-.ctms-page {
+.page {
   display: flex;
   flex-direction: column;
+  gap: 0;
 }
 
 .main-content-card :deep(.el-card__body) {
-  padding: 20px;
+  padding: 0;
 }
 
 .filter-container {
-  margin-bottom: 20px;
+  margin-bottom: 0;
 }
 
 .filter-form {
@@ -365,7 +367,7 @@ watch(
 }
 
 .filter-select-comp {
-  width: 140px;
+  width: 132px;
 }
 
 .filter-spacer {
@@ -373,9 +375,9 @@ watch(
 }
 
 .header-action-btn {
-  height: 36px;
-  padding: 0 20px;
-  border-radius: 8px;
+  height: 32px;
+  padding: 0 12px;
+  border-radius: 10px;
 }
 
 </style>

frontend/src/views/drug/ShipmentDetail.vue

@@ -1,26 +1,20 @@
 <template>
   <div class="page">
-    <div class="page-header">
-      <div>
-        <h1 class="page-title">{{ TEXT.modules.drugShipments.detailTitle }}</h1>
-        <p class="page-subtitle">{{ TEXT.modules.drugShipments.detailSubtitle }}</p>
-      </div>
-      <div class="actions">
+    <div class="unified-shell">
+      <section class="unified-section">
+        <div class="unified-section-header">
+          <div class="ctms-section-title">{{ TEXT.modules.drugShipments.detailTitle }}</div>
+          <div class="ctms-section-actions">
             <el-button type="primary" @click="goEdit">{{ TEXT.common.actions.edit }}</el-button>
             <el-button @click="goBack">{{ TEXT.common.actions.back }}</el-button>
           </div>
         </div>
-
-    <div class="content">
-      <el-card>
-        <template #header>
-          <div class="card-header">
-            <span>{{ TEXT.common.labels.basicInfo }}</span>
+        <div class="section-title-row">
+          <span class="ctms-section-title">{{ TEXT.common.labels.basicInfo }}</span>
           <el-tag :type="detail.status === 'PENDING' ? 'info' : detail.status === 'SIGNED' ? 'success' : 'primary'">
             {{ displayEnum(TEXT.enums.shipmentStatus, detail.status) }}
           </el-tag>
         </div>
-        </template>
         <el-descriptions :column="2" border>
           <el-descriptions-item :label="TEXT.common.fields.site">{{ detail.site_name || TEXT.common.fallback }}</el-descriptions-item>
           <el-descriptions-item :label="TEXT.common.fields.direction">
@@ -29,9 +23,9 @@
             </el-tag>
           </el-descriptions-item>
         </el-descriptions>
-      </el-card>
-
-      <el-card :header="TEXT.modules.drugShipments.recordLabel">
+      </section>
+      <section class="unified-section">
+        <div class="ctms-section-title section-title-inline">{{ TEXT.modules.drugShipments.recordLabel }}</div>
         <el-descriptions :column="2" border>
           <el-descriptions-item :label="TEXT.common.fields.trackingNo">{{ detail.tracking_no || TEXT.common.fallback }}</el-descriptions-item>
           <el-descriptions-item :label="TEXT.common.fields.carrier">{{ detail.carrier || TEXT.common.fallback }}</el-descriptions-item>
@@ -41,15 +35,16 @@
           <el-descriptions-item :label="TEXT.common.fields.batchNo">{{ detail.batch_no || TEXT.common.fallback }}</el-descriptions-item>
           <el-descriptions-item :label="TEXT.common.fields.remark" :span="2">{{ detail.remark || TEXT.common.fallback }}</el-descriptions-item>
         </el-descriptions>
-      </el-card>
-    </div>
-
+      </section>
+      <section class="unified-section">
         <AttachmentList
           v-if="shipmentId"
           :study-id="studyId"
           entity-type="drug_shipment"
           :entity-id="shipmentId"
         />
+      </section>
+    </div>
   </div>
 </template>
 
@@ -111,41 +106,17 @@ onMounted(load);
 .page {
   display: flex;
   flex-direction: column;
-  gap: 16px;
+  gap: 0;
 }
 
-.page-header {
-  display: flex;
-  justify-content: space-between;
-  align-items: flex-end;
-}
-
-.page-title {
-  margin: 0;
-  font-size: 22px;
-  font-weight: 600;
-}
-
-.page-subtitle {
-  margin: 6px 0 0;
-  font-size: 13px;
-  color: var(--ctms-text-secondary);
-}
-
-.content {
-  display: flex;
-  flex-direction: column;
-  gap: 16px;
-}
-
-.card-header {
+.section-title-row {
   display: flex;
   justify-content: space-between;
   align-items: center;
+  margin-bottom: 12px;
 }
 
-.actions {
-  display: flex;
-  gap: 8px;
+.section-title-inline {
+  margin-bottom: 12px;
 }
 </style>

frontend/src/views/drug/ShipmentForm.vue

@@ -1,14 +1,13 @@
 <template>
   <div class="page">
-    <div class="page-header">
-      <div>
-        <h1 class="page-title">{{ isEdit ? TEXT.modules.drugShipments.editTitle : TEXT.modules.drugShipments.newTitle }}</h1>
-        <p class="page-subtitle">{{ TEXT.modules.drugShipments.formSubtitle }}</p>
-      </div>
+    <div class="unified-shell">
+      <section class="unified-section">
+        <div class="unified-section-header">
+          <div class="ctms-section-title">{{ isEdit ? TEXT.modules.drugShipments.editTitle : TEXT.modules.drugShipments.newTitle }}</div>
+          <div class="ctms-section-actions">
             <el-button @click="goBack">{{ TEXT.common.actions.back }}</el-button>
           </div>
-
-    <el-card>
+        </div>
         <el-form ref="formRef" :model="form" :rules="rules" label-width="120px" label-position="top">
           <h3 class="section-title">{{ TEXT.common.labels.basicInfo }}</h3>
           <el-row :gutter="24">
@@ -93,17 +92,17 @@
             </div>
           </el-form-item>
         </el-form>
-    </el-card>
-
+      </section>
+      <section class="unified-section">
         <AttachmentList
           v-if="isEdit && shipmentId"
           :study-id="studyId"
           entity-type="drug_shipment"
           :entity-id="shipmentId"
         />
-    <el-card v-else class="hint-card">
-      <StateEmpty :description="TEXT.modules.drugShipments.uploadHint" />
-    </el-card>
+        <StateEmpty v-else :description="TEXT.modules.drugShipments.uploadHint" />
+      </section>
+    </div>
   </div>
 </template>
 
@@ -245,29 +244,7 @@ onMounted(async () => {
 .page {
   display: flex;
   flex-direction: column;
-  gap: 16px;
-}
-
-.page-header {
-  display: flex;
-  justify-content: space-between;
-  align-items: flex-end;
-}
-
-.page-title {
-  margin: 0;
-  font-size: 22px;
-  font-weight: 600;
-}
-
-.page-subtitle {
-  margin: 6px 0 0;
-  font-size: 13px;
-  color: var(--ctms-text-secondary);
-}
-
-.hint-card {
-  padding: 12px;
+  gap: 0;
 }
 
 .section-title {

frontend/src/views/fees/ContractFeeDetail.vue

@@ -1,15 +1,5 @@
 <template>
   <div class="page">
-      <div class="actions">
-        <el-button type="primary" :disabled="!canWrite || isReadOnly" @click="goEdit" class="header-action-btn copy-btn">
-          <el-icon class="el-icon--left"><Edit /></el-icon>
-          {{ TEXT.common.actions.edit }}
-        </el-button>
-        <el-button @click="goBack" class="header-action-btn">
-          {{ TEXT.common.actions.back }}
-        </el-button>
-      </div>
-
     <StateError v-if="errorMessage" :description="errorMessage">
       <template #action>
         <el-button type="primary" @click="load">{{ TEXT.common.actions.retry }}</el-button>
@@ -19,10 +9,19 @@
     <StateLoading v-else-if="loading" :rows="6" />
 
     <template v-else>
-      <el-card class="detail-card" shadow="never">
+      <el-card class="detail-card unified-shell" shadow="never">
         <template #header>
-          <div class="card-header">
+          <div class="card-header actions-header">
             <span class="header-title">{{ TEXT.common.labels.basicInfo }}</span>
+            <div class="actions">
+              <el-button type="primary" :disabled="!canWrite || isReadOnly" @click="goEdit" class="header-action-btn copy-btn">
+                <el-icon class="el-icon--left"><Edit /></el-icon>
+                {{ TEXT.common.actions.edit }}
+              </el-button>
+              <el-button @click="goBack" class="header-action-btn">
+                {{ TEXT.common.actions.back }}
+              </el-button>
+            </div>
           </div>
         </template>
         <el-descriptions :column="2" border class="custom-descriptions">
@@ -47,7 +46,7 @@
         </el-descriptions>
       </el-card>
 
-      <el-card class="section-card" shadow="never">
+      <el-card class="section-card unified-shell" shadow="never">
         <template #header>
           <div class="card-header">
             <span class="header-title">{{ TEXT.modules.feeContracts.paymentTitle }}</span>
@@ -89,7 +88,7 @@
         <StateEmpty v-if="detail.payments.length === 0" :description="TEXT.modules.feeContracts.paymentEmpty" />
       </el-card>
 
-      <el-card class="section-card" shadow="never">
+      <el-card class="section-card unified-shell" shadow="never">
         <template #header>
           <div class="card-header">
             <span class="header-title">{{ TEXT.modules.feeContracts.attachmentTitle }}</span>
@@ -232,26 +231,7 @@ onMounted(async () => {
 .page {
   display: flex;
   flex-direction: column;
-  gap: 12px;
-}
-
-.page-header {
-  display: flex;
-  justify-content: space-between;
-  align-items: center;
-}
-
-.page-title {
-  margin: 0;
-  font-size: 24px;
-  font-weight: 700;
-  color: var(--ctms-text-main);
-}
-
-.page-subtitle {
-  margin: 6px 0 0;
-  font-size: 14px;
-  color: var(--ctms-text-secondary);
+  gap: 0;
 }
 
 .actions {
@@ -275,6 +255,12 @@ onMounted(async () => {
   padding: 4px 0;
 }
 
+.actions-header {
+  display: flex;
+  justify-content: space-between;
+  align-items: center;
+}
+
 .header-title {
   font-size: 16px;
   font-weight: 600;

frontend/src/views/fees/ContractFeeForm.vue

@@ -1,15 +1,5 @@
 <template>
   <div class="page">
-    <div class="page-header">
-      <div>
-        <h1 class="page-title">{{ isEdit ? TEXT.modules.feeContracts.editTitle : TEXT.modules.feeContracts.newTitle }}</h1>
-        <p class="page-subtitle">{{ TEXT.modules.feeContracts.formSubtitle }}</p>
-      </div>
-      <div class="actions">
-        <el-button @click="goBack" class="header-action-btn">{{ TEXT.common.actions.back }}</el-button>
-      </div>
-    </div>
-
     <StateError v-if="errorMessage" :description="errorMessage">
       <template #action>
         <el-button type="primary" @click="loadDetail">{{ TEXT.common.actions.retry }}</el-button>
@@ -20,10 +10,11 @@
 
     <template v-else>
         <el-form ref="formRef" :model="form" :rules="rules" label-width="140px" label-position="top">
-        <el-card class="form-card" shadow="never">
+          <el-card class="form-card unified-shell" shadow="never">
           <template #header>
-            <div class="card-header">
+            <div class="card-header actions-header">
               <span class="header-title">{{ TEXT.common.labels.basicInfo }}</span>
+              <el-button @click="goBack">{{ TEXT.common.actions.back }}</el-button>
             </div>
           </template>
           <el-row :gutter="24">
@@ -97,7 +88,7 @@
           </el-row>
         </el-card>
 
-        <el-card class="form-card section-margin" shadow="never">
+        <el-card class="form-card section-margin unified-shell" shadow="never">
           <template #header>
             <div class="card-header actions-header">
               <span class="header-title">{{ TEXT.modules.feeContracts.paymentTitle }}</span>
@@ -183,7 +174,7 @@
           </div>
         </el-card>
 
-        <el-card class="form-card section-margin" shadow="never">
+        <el-card class="form-card section-margin unified-shell" shadow="never">
           <template #header>
             <div class="card-header">
               <span class="header-title">{{ TEXT.modules.feeContracts.attachmentTitle }}</span>
@@ -512,36 +503,10 @@ onMounted(async () => {
 .page {
   display: flex;
   flex-direction: column;
-  gap: 24px;
-  max-width: 1000px;
-  margin: 0 auto;
+  gap: 0;
   width: 100%;
 }
 
-.page-header {
-  display: flex;
-  justify-content: space-between;
-  align-items: flex-end;
-}
-
-.page-title {
-  margin: 0;
-  font-size: 24px;
-  font-weight: 700;
-  color: var(--ctms-text-main);
-}
-
-.page-subtitle {
-  margin: 6px 0 0;
-  font-size: 14px;
-  color: var(--ctms-text-secondary);
-}
-
-.header-action-btn {
-  height: 36px;
-  border-radius: 8px;
-}
-
 .form-card {
   border-radius: 12px;
   border: 1px solid var(--ctms-border-color);

frontend/src/views/fees/ContractFees.vue

@@ -1,6 +1,5 @@
 <template>
   <div class="page">
-
     <div class="overview">
       <el-row :gutter="20">
         <el-col :xs="24" :sm="12" :md="6">
@@ -46,8 +45,16 @@
       </el-row>
     </div>
 
-    <el-card shadow="never" class="main-content-card" v-if="!errorMessage && !loading">
-      <div class="filter-container">
+    <StateError v-if="errorMessage" :description="errorMessage">
+      <template #action>
+        <el-button type="primary" @click="load">{{ TEXT.common.actions.retry }}</el-button>
+      </template>
+    </StateError>
+
+    <StateLoading v-else-if="loading" :rows="6" />
+
+    <el-card shadow="never" class="main-content-card unified-shell" v-else>
+      <div class="filter-container unified-action-bar">
         <el-form :inline="true" :model="filters" class="filter-form">
           <el-form-item label="" class="filter-item">
             <el-select v-model="filters.centerId" clearable :placeholder="TEXT.common.fields.site" class="filter-select">
@@ -79,15 +86,7 @@
           </el-button>
         </el-form>
       </div>
-
-    <StateError v-if="errorMessage" :description="errorMessage">
-      <template #action>
-        <el-button type="primary" @click="load">{{ TEXT.common.actions.retry }}</el-button>
-      </template>
-    </StateError>
-
-    <StateLoading v-else-if="loading" :rows="6" />
-
+      <section class="unified-section">
         <el-table
           :data="sortedContracts"
           style="width: 100%"
@@ -167,6 +166,7 @@
           </el-table-column>
         </el-table>
         <StateEmpty v-if="sortedContracts.length === 0" :description="TEXT.modules.feeContracts.empty" />
+      </section>
     </el-card>
   </div>
 </template>
@@ -347,14 +347,15 @@ onMounted(async () => {
 .page {
   display: flex;
   flex-direction: column;
+  gap: 0;
 }
 
 .main-content-card :deep(.el-card__body) {
-  padding: 20px;
+  padding: 0;
 }
 
 .filter-container {
-  margin-bottom: 20px;
+  margin-bottom: 0;
 }
 
 .filter-form {

frontend/src/views/fees/SpecialExpenseDetail.vue

@@ -1,15 +1,5 @@
 <template>
   <div class="page">
-    <div class="actions">
-      <el-button type="primary" :disabled="!canWrite || isReadOnly" @click="goEdit" class="header-action-btn copy-btn">
-        <el-icon class="el-icon--left"><Edit /></el-icon>
-        {{ TEXT.common.actions.edit }}
-      </el-button>
-      <el-button @click="goBack" class="header-action-btn">
-        {{ TEXT.common.actions.back }}
-      </el-button>
-    </div>
-
     <StateError v-if="errorMessage" :description="errorMessage">
       <template #action>
         <el-button type="primary" @click="load">{{ TEXT.common.actions.retry }}</el-button>
@@ -19,16 +9,23 @@
     <StateLoading v-else-if="loading" :rows="6" />
 
     <template v-else>
-      <el-card class="detail-card" shadow="never">
+      <el-card class="detail-card unified-shell" shadow="never">
         <template #header>
           <div class="card-header">
             <span class="header-title">{{ TEXT.common.labels.basicInfo }}</span>
-            <div class="status-badges">
+            <div class="status-badges actions">
               <el-tag v-if="detail.is_paid" type="success" effect="dark" size="default">{{ TEXT.modules.feeSpecials.isPaid }}</el-tag>
               <el-tag v-else type="info" effect="plain" size="default">{{ TEXT.modules.feeSpecials.unpaid }}</el-tag>
 
               <el-tag v-if="detail.is_verified" type="info" effect="dark" size="default">{{ TEXT.modules.feeSpecials.isVerified }}</el-tag>
               <el-tag v-else type="info" effect="plain" size="default">{{ TEXT.modules.feeSpecials.unverified }}</el-tag>
+              <el-button type="primary" :disabled="!canWrite || isReadOnly" @click="goEdit" class="header-action-btn copy-btn">
+                <el-icon class="el-icon--left"><Edit /></el-icon>
+                {{ TEXT.common.actions.edit }}
+              </el-button>
+              <el-button @click="goBack" class="header-action-btn">
+                {{ TEXT.common.actions.back }}
+              </el-button>
             </div>
           </div>
         </template>
@@ -65,7 +62,7 @@
         </el-descriptions>
       </el-card>
 
-      <el-card class="section-card" shadow="never">
+      <el-card class="section-card unified-shell" shadow="never">
         <template #header>
           <div class="card-header">
             <span class="header-title">{{ TEXT.modules.feeSpecials.attachmentTitle }}</span>
@@ -216,26 +213,7 @@ onMounted(async () => {
 .page {
   display: flex;
   flex-direction: column;
-  gap: 20px;
-}
-
-.page-header {
-  display: flex;
-  justify-content: space-between;
-  align-items: center;
-}
-
-.page-title {
-  margin: 0;
-  font-size: 24px;
-  font-weight: 700;
-  color: var(--ctms-text-main);
-}
-
-.page-subtitle {
-  margin: 6px 0 0;
-  font-size: 14px;
-  color: var(--ctms-text-secondary);
+  gap: 0;
 }
 
 .actions {

frontend/src/views/fees/SpecialExpenseForm.vue

@@ -1,15 +1,5 @@
 <template>
   <div class="page">
-    <div class="page-header">
-      <div>
-        <h1 class="page-title">{{ isEdit ? TEXT.modules.feeSpecials.editTitle : TEXT.modules.feeSpecials.newTitle }}</h1>
-        <p class="page-subtitle">{{ TEXT.modules.feeSpecials.formSubtitle }}</p>
-      </div>
-      <div class="actions">
-        <el-button @click="goBack" class="header-action-btn">{{ TEXT.common.actions.back }}</el-button>
-      </div>
-    </div>
-
     <StateError v-if="errorMessage" :description="errorMessage">
       <template #action>
         <el-button type="primary" @click="loadDetail">{{ TEXT.common.actions.retry }}</el-button>
@@ -20,10 +10,11 @@
 
     <template v-else>
       <el-form ref="formRef" :model="form" :rules="rules" label-width="120px" label-position="top">
-        <el-card class="form-card" shadow="never">
+        <el-card class="form-card unified-shell" shadow="never">
           <template #header>
-            <div class="card-header">
+            <div class="card-header header-actions-row">
               <span class="header-title">{{ TEXT.common.labels.basicInfo }}</span>
+              <el-button @click="goBack">{{ TEXT.common.actions.back }}</el-button>
             </div>
           </template>
           <el-row :gutter="24">
@@ -65,7 +56,7 @@
           </el-row>
         </el-card>
 
-        <el-card class="form-card section-margin" shadow="never">
+        <el-card class="form-card section-margin unified-shell" shadow="never">
           <template #header>
             <div class="card-header">
               <span class="header-title">{{ TEXT.common.fields.status }}</span>
@@ -116,7 +107,7 @@
           </div>
         </el-card>
 
-        <el-card class="form-card section-margin" shadow="never">
+        <el-card class="form-card section-margin unified-shell" shadow="never">
           <template #header>
             <div class="card-header">
               <span class="header-title">{{ TEXT.modules.feeSpecials.attachmentTitle }}</span>
@@ -389,37 +380,10 @@ onMounted(async () => {
 .page {
   display: flex;
   flex-direction: column;
-  gap: 24px;
-  max-width: 1000px;
-  margin: 0 auto;
+  gap: 0;
   width: 100%;
 }
 
-.page-header {
-  display: flex;
-  justify-content: space-between;
-  align-items: flex-end;
-}
-
-.page-title {
-  margin: 0;
-  font-size: 24px;
-  font-weight: 700;
-  color: var(--ctms-text-main);
-}
-
-.page-subtitle {
-  margin: 6px 0 0;
-  font-size: 14px;
-  color: var(--ctms-text-secondary);
-}
-
-.header-action-btn {
-  height: 36px;
-  border-radius: 8px;
-  padding: 0 16px;
-}
-
 .form-card {
   border-radius: 12px;
   border: 1px solid var(--ctms-border-color);
@@ -434,6 +398,12 @@ onMounted(async () => {
   padding: 4px 0;
 }
 
+.header-actions-row {
+  display: flex;
+  justify-content: space-between;
+  align-items: center;
+}
+
 .header-title {
   font-size: 16px;
   font-weight: 600;

frontend/src/views/fees/SpecialExpenses.vue

@@ -1,6 +1,5 @@
 <template>
   <div class="page">
-
     <div class="overview">
       <el-row :gutter="20">
         <el-col :xs="24" :sm="12" :md="6">
@@ -45,8 +44,16 @@
       </el-row>
     </div>
 
-    <el-card shadow="never" class="main-content-card" v-if="!errorMessage && !loading">
-      <div class="filter-container">
+    <StateError v-if="errorMessage" :description="errorMessage">
+      <template #action>
+        <el-button type="primary" @click="load">{{ TEXT.common.actions.retry }}</el-button>
+      </template>
+    </StateError>
+
+    <StateLoading v-else-if="loading" :rows="6" />
+
+    <el-card shadow="never" class="main-content-card unified-shell" v-else>
+      <div class="filter-container unified-action-bar">
         <el-form :inline="true" :model="filters" class="filter-form">
           <el-form-item label="" class="filter-item">
             <el-select v-model="filters.centerId" clearable :placeholder="TEXT.common.fields.site" class="filter-select">
@@ -90,6 +97,7 @@
           </el-button>
         </el-form>
       </div>
+      <section class="unified-section">
         <el-table
           :data="sortedExpenses"
           style="width: 100%"
@@ -157,6 +165,7 @@
           </el-table-column>
         </el-table>
         <StateEmpty v-if="sortedExpenses.length === 0" :description="TEXT.modules.feeSpecials.empty" />
+      </section>
     </el-card>
   </div>
 </template>
@@ -343,14 +352,15 @@ onMounted(async () => {
 .page {
   display: flex;
   flex-direction: column;
+  gap: 0;
 }
 
 .main-content-card :deep(.el-card__body) {
-  padding: 20px;
+  padding: 0;
 }
 
 .filter-container {
-  margin-bottom: 20px;
+  margin-bottom: 0;
 }
 
 .filter-form {

frontend/src/views/finance/ContractDetail.vue

@@ -1,17 +1,14 @@
 <template>
   <div class="page">
-    <div class="page-header">
-      <div>
-        <h1 class="page-title">{{ TEXT.modules.financeContracts.detailTitle }}</h1>
-        <p class="page-subtitle">{{ TEXT.modules.financeContracts.detailSubtitle }}</p>
-      </div>
-      <div class="actions">
+    <div class="unified-shell">
+      <section class="unified-section" v-loading="loading">
+        <div class="unified-section-header">
+          <div class="ctms-section-title">{{ TEXT.modules.financeContracts.detailTitle }}</div>
+          <div class="ctms-section-actions">
             <el-button type="primary" :disabled="isReadOnly" @click="goEdit">{{ TEXT.common.actions.edit }}</el-button>
             <el-button @click="goBack">{{ TEXT.common.actions.back }}</el-button>
           </div>
         </div>
-
-    <el-card v-loading="loading">
         <el-descriptions :column="2" border>
           <el-descriptions-item :label="TEXT.common.fields.site">{{ detail.site_name || TEXT.common.fallback }}</el-descriptions-item>
           <el-descriptions-item :label="TEXT.common.fields.contractNo">{{ detail.contract_no || TEXT.common.fallback }}</el-descriptions-item>
@@ -21,8 +18,8 @@
           </el-descriptions-item>
           <el-descriptions-item :label="TEXT.common.fields.remark" :span="2">{{ detail.remark || TEXT.common.fallback }}</el-descriptions-item>
         </el-descriptions>
-    </el-card>
-
+      </section>
+      <section class="unified-section">
         <AttachmentList
           v-if="contractId"
           :study-id="studyId"
@@ -30,6 +27,8 @@
           :entity-id="contractId"
           :readonly="isReadOnly"
         />
+      </section>
+    </div>
   </div>
 </template>
 
@@ -112,29 +111,6 @@ onMounted(async () => {
 .page {
   display: flex;
   flex-direction: column;
-  gap: 16px;
-}
-
-.page-header {
-  display: flex;
-  justify-content: space-between;
-  align-items: flex-end;
-}
-
-.page-title {
-  margin: 0;
-  font-size: 22px;
-  font-weight: 600;
-}
-
-.page-subtitle {
-  margin: 6px 0 0;
-  font-size: 13px;
-  color: var(--ctms-text-secondary);
-}
-
-.actions {
-  display: flex;
-  gap: 8px;
+  gap: 0;
 }
 </style>

frontend/src/views/finance/ContractForm.vue

@@ -1,14 +1,13 @@
 <template>
   <div class="page">
-    <div class="page-header">
-      <div>
-        <h1 class="page-title">{{ isEdit ? TEXT.modules.financeContracts.editTitle : TEXT.modules.financeContracts.newTitle }}</h1>
-        <p class="page-subtitle">{{ TEXT.modules.financeContracts.formSubtitle }}</p>
-      </div>
+    <div class="unified-shell">
+      <section class="unified-section">
+        <div class="unified-section-header">
+          <div class="ctms-section-title">{{ isEdit ? TEXT.modules.financeContracts.editTitle : TEXT.modules.financeContracts.newTitle }}</div>
+          <div class="ctms-section-actions">
             <el-button @click="goBack">{{ TEXT.common.actions.back }}</el-button>
           </div>
-
-    <el-card>
+        </div>
         <el-form ref="formRef" :model="form" label-width="110px">
           <el-form-item :label="TEXT.common.fields.site" prop="site_name" required>
             <el-input v-model="form.site_name" :disabled="isReadOnly" :placeholder="TEXT.common.placeholders.input + TEXT.common.fields.site" />
@@ -37,8 +36,8 @@
             <el-button @click="goBack">{{ TEXT.common.actions.cancel }}</el-button>
           </el-form-item>
         </el-form>
-    </el-card>
-
+      </section>
+      <section class="unified-section">
         <AttachmentList
           v-if="isEdit && contractId"
           :study-id="studyId"
@@ -46,9 +45,9 @@
           :entity-id="contractId"
           :readonly="isReadOnly"
         />
-    <el-card v-else class="hint-card">
-      <StateEmpty :description="TEXT.modules.financeContracts.uploadHint" />
-    </el-card>
+        <StateEmpty v-else :description="TEXT.modules.financeContracts.uploadHint" />
+      </section>
+    </div>
   </div>
 </template>
 
@@ -170,28 +169,6 @@ onMounted(async () => {
 .page {
   display: flex;
   flex-direction: column;
-  gap: 16px;
-}
-
-.page-header {
-  display: flex;
-  justify-content: space-between;
-  align-items: flex-end;
-}
-
-.page-title {
-  margin: 0;
-  font-size: 22px;
-  font-weight: 600;
-}
-
-.page-subtitle {
-  margin: 6px 0 0;
-  font-size: 13px;
-  color: var(--ctms-text-secondary);
-}
-
-.hint-card {
-  padding: 12px;
+  gap: 0;
 }
 </style>

frontend/src/views/finance/SpecialDetail.vue

@@ -1,17 +1,14 @@
 <template>
   <div class="page">
-    <div class="page-header">
-      <div>
-        <h1 class="page-title">{{ TEXT.modules.financeSpecials.detailTitle }}</h1>
-        <p class="page-subtitle">{{ TEXT.modules.financeSpecials.detailSubtitle }}</p>
-      </div>
-      <div class="actions">
+    <div class="unified-shell">
+      <section class="unified-section" v-loading="loading">
+        <div class="unified-section-header">
+          <div class="ctms-section-title">{{ TEXT.modules.financeSpecials.detailTitle }}</div>
+          <div class="ctms-section-actions">
             <el-button type="primary" :disabled="isReadOnly" @click="goEdit">{{ TEXT.common.actions.edit }}</el-button>
             <el-button @click="goBack">{{ TEXT.common.actions.back }}</el-button>
           </div>
         </div>
-
-    <el-card v-loading="loading">
         <el-descriptions :column="2" border>
           <el-descriptions-item :label="TEXT.common.fields.site">{{ detail.site_name || TEXT.common.fallback }}</el-descriptions-item>
           <el-descriptions-item :label="TEXT.common.fields.type">{{ displayEnum(TEXT.enums.financeSpecialType, detail.fee_type) }}</el-descriptions-item>
@@ -20,8 +17,8 @@
           <el-descriptions-item :label="TEXT.common.fields.amount">{{ detail.amount || TEXT.common.fallback }}</el-descriptions-item>
           <el-descriptions-item :label="TEXT.common.fields.remark" :span="2">{{ detail.remark || TEXT.common.fallback }}</el-descriptions-item>
         </el-descriptions>
-    </el-card>
-
+      </section>
+      <section class="unified-section">
         <AttachmentList
           v-if="specialId"
           :study-id="studyId"
@@ -29,6 +26,8 @@
           :entity-id="specialId"
           :readonly="isReadOnly"
         />
+      </section>
+    </div>
   </div>
 </template>
 
@@ -111,29 +110,6 @@ onMounted(async () => {
 .page {
   display: flex;
   flex-direction: column;
-  gap: 16px;
-}
-
-.page-header {
-  display: flex;
-  justify-content: space-between;
-  align-items: flex-end;
-}
-
-.page-title {
-  margin: 0;
-  font-size: 22px;
-  font-weight: 600;
-}
-
-.page-subtitle {
-  margin: 6px 0 0;
-  font-size: 13px;
-  color: var(--ctms-text-secondary);
-}
-
-.actions {
-  display: flex;
-  gap: 8px;
+  gap: 0;
 }
 </style>

frontend/src/views/finance/SpecialForm.vue

@@ -1,14 +1,13 @@
 <template>
   <div class="page">
-    <div class="page-header">
-      <div>
-        <h1 class="page-title">{{ isEdit ? TEXT.modules.financeSpecials.editTitle : TEXT.modules.financeSpecials.newTitle }}</h1>
-        <p class="page-subtitle">{{ TEXT.modules.financeSpecials.subtitle }}</p>
-      </div>
+    <div class="unified-shell">
+      <section class="unified-section">
+        <div class="unified-section-header">
+          <div class="ctms-section-title">{{ isEdit ? TEXT.modules.financeSpecials.editTitle : TEXT.modules.financeSpecials.newTitle }}</div>
+          <div class="ctms-section-actions">
             <el-button @click="goBack">{{ TEXT.common.actions.back }}</el-button>
           </div>
-
-    <el-card>
+        </div>
         <el-form :model="form" label-width="110px">
           <el-form-item :label="TEXT.common.fields.site" required>
             <el-input v-model="form.site_name" :disabled="isReadOnly" :placeholder="TEXT.common.placeholders.input + TEXT.common.fields.site" />
@@ -38,8 +37,8 @@
             <el-button @click="goBack">{{ TEXT.common.actions.cancel }}</el-button>
           </el-form-item>
         </el-form>
-    </el-card>
-
+      </section>
+      <section class="unified-section">
         <AttachmentList
           v-if="isEdit && specialId"
           :study-id="studyId"
@@ -47,9 +46,9 @@
           :entity-id="specialId"
           :readonly="isReadOnly"
         />
-    <el-card v-else class="hint-card">
-      <StateEmpty :description="TEXT.modules.financeSpecials.uploadHint" />
-    </el-card>
+        <StateEmpty v-else :description="TEXT.modules.financeSpecials.uploadHint" />
+      </section>
+    </div>
   </div>
 </template>
 
@@ -171,28 +170,6 @@ onMounted(async () => {
 .page {
   display: flex;
   flex-direction: column;
-  gap: 16px;
-}
-
-.page-header {
-  display: flex;
-  justify-content: space-between;
-  align-items: flex-end;
-}
-
-.page-title {
-  margin: 0;
-  font-size: 22px;
-  font-weight: 600;
-}
-
-.page-subtitle {
-  margin: 6px 0 0;
-  font-size: 13px;
-  color: var(--ctms-text-secondary);
-}
-
-.hint-card {
-  padding: 12px;
+  gap: 0;
 }
 </style>

frontend/src/views/ia/DrugShipments.vue

@@ -1,8 +1,8 @@
 <template>
   <div class="page">
 
-    <el-card shadow="never" class="main-content-card">
-      <div class="filter-container">
+    <el-card shadow="never" class="main-content-card unified-shell">
+      <div class="filter-container unified-action-bar">
         <el-form :inline="true" :model="filters" class="filter-form">
           <el-form-item label="" class="filter-item">
             <el-select v-model="filters.center_id" clearable :placeholder="TEXT.common.fields.site" class="filter-select">
@@ -42,12 +42,13 @@
             <el-button @click="resetFilters">{{ TEXT.common.actions.reset }}</el-button>
           </el-form-item>
           <div class="filter-spacer"></div>
-          <el-button type="primary" @click="goNew" class="header-action-btn">
+          <el-button type="primary" @click="goNew">
             <el-icon class="el-icon--left"><Plus /></el-icon>
             {{ TEXT.modules.drugShipments.newTitle }}
           </el-button>
         </el-form>
       </div>
+      <div class="unified-section table-section">
         <el-table
           :data="sortedItems"
           v-loading="loading"
@@ -102,6 +103,7 @@
           </el-table-column>
         </el-table>
         <StateEmpty v-if="!loading && sortedItems.length === 0" :description="TEXT.modules.drugShipments.empty" />
+      </div>
     </el-card>
   </div>
 </template>
@@ -247,14 +249,6 @@ onMounted(async () => {
   flex-direction: column;
 }
 
-.main-content-card :deep(.el-card__body) {
-  padding: 20px;
-}
-
-.filter-container {
-  margin-bottom: 20px;
-}
-
 .filter-form {
   display: flex;
   width: 100%;
@@ -291,10 +285,9 @@ onMounted(async () => {
   flex: 1;
 }
 
-.header-action-btn {
-  height: 36px;
-  padding: 0 20px;
-  border-radius: 8px;
+.table-section {
+  padding-top: 12px;
+  padding-bottom: 12px;
 }
 
 .type-tag {

frontend/src/views/ia/EtmfPlaceholder.vue

@@ -0,0 +1,13 @@
+<template>
+  <ModulePlaceholder
+    :title="TEXT.modules.etmf.title"
+    :subtitle="TEXT.modules.etmf.subtitle"
+    :list-title="TEXT.modules.etmf.listTitle"
+    :empty-description="TEXT.modules.etmf.emptyDescription"
+  />
+</template>
+
+<script setup lang="ts">
+import ModulePlaceholder from "../../components/ModulePlaceholder.vue";
+import { TEXT } from "../../locales";
+</script>

frontend/src/views/ia/FinanceContracts.vue

@@ -1,8 +1,7 @@
 <template>
   <div class="page">
-
-    <el-card class="filter-card" shadow="never">
-      <div class="filter-row">
+    <el-card shadow="never" class="main-content-card unified-shell">
+      <div class="filter-container unified-action-bar">
         <el-form :inline="true" :model="filters" class="filter-form">
           <el-form-item label="" class="filter-item-form">
             <el-input 
@@ -24,14 +23,12 @@
             <el-button @click="resetFilters">{{ TEXT.common.actions.reset }}</el-button>
           </el-form-item>
           <div class="filter-spacer"></div>
-          <el-button type="primary" @click="goNew" class="header-action-btn">
+          <el-button type="primary" @click="goNew">
             {{ TEXT.modules.financeContracts.newTitle }}
           </el-button>
         </el-form>
       </div>
-    </el-card>
-
-    <el-card>
+      <div class="unified-section table-section">
         <el-table
           :data="sortedItems"
           v-loading="loading"
@@ -72,6 +69,7 @@
           </el-table-column>
         </el-table>
         <StateEmpty v-if="!loading && sortedItems.length === 0" :description="TEXT.modules.financeContracts.empty" />
+      </div>
     </el-card>
   </div>
 </template>
@@ -185,17 +183,6 @@ onMounted(async () => {
 .page {
   display: flex;
   flex-direction: column;
-  gap: 12px;
-}
-
-.filter-card {
-  border: none;
-  background-color: transparent;
-  padding: 0;
-}
-
-.filter-card :deep(.el-card__body) {
-  padding: 0;
 }
 
 .filter-form {
@@ -203,18 +190,6 @@ onMounted(async () => {
   width: 100%;
   gap: 12px;
   align-items: center;
-  background: white;
-  padding: 12px 16px;
-  border-radius: 10px;
-  border: 1px solid var(--ctms-border-color);
-  box-sizing: border-box;
-}
-
-.filter-row {
-  display: flex;
-  align-items: center;
-  gap: 12px;
-  flex-wrap: wrap;
 }
 
 .filter-item-form {
@@ -230,10 +205,9 @@ onMounted(async () => {
   flex: 1;
 }
 
-.header-action-btn {
-  height: 36px;
-  padding: 0 20px;
-  border-radius: 8px;
+.table-section {
+  padding-top: 12px;
+  padding-bottom: 12px;
 }
 
 

frontend/src/views/ia/FinanceSpecial.vue

@@ -1,8 +1,7 @@
 <template>
   <div class="page">
-
-    <el-card class="filter-card" shadow="never">
-      <div class="filter-row">
+    <el-card shadow="never" class="main-content-card unified-shell">
+      <div class="filter-container unified-action-bar">
         <el-form :inline="true" :model="filters" class="filter-form">
           <el-form-item label="" class="filter-item-form">
             <el-input 
@@ -29,14 +28,12 @@
             <el-button @click="resetFilters">{{ TEXT.common.actions.reset }}</el-button>
           </el-form-item>
           <div class="filter-spacer"></div>
-          <el-button type="primary" @click="goNew" class="header-action-btn">
+          <el-button type="primary" @click="goNew">
             {{ TEXT.modules.financeSpecials.newTitle }}
           </el-button>
         </el-form>
       </div>
-    </el-card>
-
-    <el-card>
+      <div class="unified-section table-section">
         <el-table
           :data="sortedItems"
           v-loading="loading"
@@ -82,6 +79,7 @@
           </el-table-column>
         </el-table>
         <StateEmpty v-if="!loading && sortedItems.length === 0" :description="TEXT.modules.financeSpecials.empty" />
+      </div>
     </el-card>
   </div>
 </template>
@@ -194,17 +192,6 @@ onMounted(async () => {
 .page {
   display: flex;
   flex-direction: column;
-  gap: 12px;
-}
-
-.filter-card {
-  border: none;
-  background-color: transparent;
-  padding: 0;
-}
-
-.filter-card :deep(.el-card__body) {
-  padding: 0;
 }
 
 .filter-form {
@@ -212,18 +199,6 @@ onMounted(async () => {
   width: 100%;
   gap: 12px;
   align-items: center;
-  background: white;
-  padding: 12px 16px;
-  border-radius: 10px;
-  border: 1px solid var(--ctms-border-color);
-  box-sizing: border-box;
-}
-
-.filter-row {
-  display: flex;
-  align-items: center;
-  gap: 12px;
-  flex-wrap: wrap;
 }
 
 .filter-item-form {
@@ -243,10 +218,9 @@ onMounted(async () => {
   flex: 1;
 }
 
-.header-action-btn {
-  height: 36px;
-  padding: 0 20px;
-  border-radius: 8px;
+.table-section {
+  padding-top: 12px;
+  padding-bottom: 12px;
 }
 
 </style>

frontend/src/views/ia/KnowledgeNotes.vue

@@ -1,8 +1,8 @@
 <template>
   <div class="page">
 
-    <el-card shadow="never" class="main-content-card">
-      <div class="filter-container">
+    <el-card shadow="never" class="main-content-card unified-shell">
+      <div class="filter-container unified-action-bar">
         <el-form :inline="true" :model="filters" class="filter-form">
           <el-form-item label="" class="filter-item-form">
             <el-input 
@@ -24,11 +24,12 @@
             <el-button @click="resetFilters">{{ TEXT.common.actions.reset }}</el-button>
           </el-form-item>
           <div class="filter-spacer"></div>
-          <el-button type="primary" @click="goNew" class="header-action-btn">
+          <el-button type="primary" @click="goNew">
             {{ TEXT.modules.knowledgeNotes.newTitle }}
           </el-button>
         </el-form>
       </div>
+      <div class="unified-section table-section">
         <el-table
           :data="sortedItems"
           v-loading="loading"
@@ -58,6 +59,7 @@
           </el-table-column>
         </el-table>
         <StateEmpty v-if="!loading && sortedItems.length === 0" :description="TEXT.modules.knowledgeNotes.empty" />
+      </div>
     </el-card>
   </div>
 </template>
@@ -173,14 +175,6 @@ onMounted(async () => {
   flex-direction: column;
 }
 
-.main-content-card :deep(.el-card__body) {
-  padding: 20px;
-}
-
-.filter-container {
-  margin-bottom: 20px;
-}
-
 .filter-form {
   display: flex;
   width: 100%;
@@ -201,10 +195,9 @@ onMounted(async () => {
   flex: 1;
 }
 
-.header-action-btn {
-  height: 36px;
-  padding: 0 20px;
-  border-radius: 8px;
+.table-section {
+  padding-top: 12px;
+  padding-bottom: 12px;
 }
 
 </style>

frontend/src/views/ia/MaterialEquipment.vue

@@ -0,0 +1,13 @@
+<template>
+  <ModulePlaceholder
+    :title="TEXT.modules.materialEquipment.title"
+    :subtitle="TEXT.modules.materialEquipment.subtitle"
+    :list-title="TEXT.modules.materialEquipment.listTitle"
+    :empty-description="TEXT.modules.materialEquipment.emptyDescription"
+  />
+</template>
+
+<script setup lang="ts">
+import ModulePlaceholder from "../../components/ModulePlaceholder.vue";
+import { TEXT } from "../../locales";
+</script>

frontend/src/views/ia/MaterialOthers.vue

@@ -0,0 +1,13 @@
+<template>
+  <ModulePlaceholder
+    :title="TEXT.modules.materialOthers.title"
+    :subtitle="TEXT.modules.materialOthers.subtitle"
+    :list-title="TEXT.modules.materialOthers.listTitle"
+    :empty-description="TEXT.modules.materialOthers.emptyDescription"
+  />
+</template>
+
+<script setup lang="ts">
+import ModulePlaceholder from "../../components/ModulePlaceholder.vue";
+import { TEXT } from "../../locales";
+</script>

frontend/src/views/ia/MonitoringAuditPlaceholder.vue

@@ -0,0 +1,13 @@
+<template>
+  <ModulePlaceholder
+    :title="TEXT.modules.monitoringAudit.title"
+    :subtitle="TEXT.modules.monitoringAudit.subtitle"
+    :list-title="TEXT.modules.monitoringAudit.listTitle"
+    :empty-description="TEXT.modules.monitoringAudit.emptyDescription"
+  />
+</template>
+
+<script setup lang="ts">
+import ModulePlaceholder from "../../components/ModulePlaceholder.vue";
+import { TEXT } from "../../locales";
+</script>

frontend/src/views/ia/ProjectMilestones.vue

@@ -0,0 +1,13 @@
+<template>
+  <ModulePlaceholder
+    :title="TEXT.modules.projectMilestones.title"
+    :subtitle="TEXT.modules.projectMilestones.subtitle"
+    :list-title="TEXT.modules.projectMilestones.listTitle"
+    :empty-description="TEXT.modules.projectMilestones.emptyDescription"
+  />
+</template>
+
+<script setup lang="ts">
+import ModulePlaceholder from "../../components/ModulePlaceholder.vue";
+import { TEXT } from "../../locales";
+</script>