参与者管理- PD模块内容补充

backend/alembic/versions/20260228_01_add_subject_pds.py

@@ -0,0 +1,75 @@
+"""add subject_pds table
+
+Revision ID: 20260228_01
+Revises: 20260227_06
+Create Date: 2026-02-28 10:30:00.000000
+
+"""
+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 = "20260228_01"
+down_revision: Union[str, None] = "20260227_06"
+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)
+    table_names = set(inspector.get_table_names())
+
+    if "subject_pds" not in table_names:
+        op.create_table(
+            "subject_pds",
+            sa.Column("id", postgresql.UUID(as_uuid=True), nullable=False),
+            sa.Column("study_id", postgresql.UUID(as_uuid=True), nullable=False),
+            sa.Column("subject_id", postgresql.UUID(as_uuid=True), nullable=False),
+            sa.Column("pd_no", sa.String(length=64), nullable=False),
+            sa.Column("pd_type", sa.String(length=100), nullable=False),
+            sa.Column("pd_level", sa.String(length=20), nullable=False, server_default=sa.text("'GENERAL'")),
+            sa.Column("approval_status", sa.String(length=20), nullable=False, server_default=sa.text("'DRAFT'")),
+            sa.Column("description", sa.Text(), nullable=True),
+            sa.Column("status", sa.String(length=20), nullable=False, server_default=sa.text("'OPEN'")),
+            sa.Column("created_by", postgresql.UUID(as_uuid=True), 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(["study_id"], ["studies.id"]),
+            sa.ForeignKeyConstraint(["subject_id"], ["subjects.id"]),
+            sa.ForeignKeyConstraint(["created_by"], ["users.id"]),
+            sa.PrimaryKeyConstraint("id"),
+            sa.UniqueConstraint("study_id", "pd_no", name="uq_subject_pds_study_pd_no"),
+        )
+        table_names.add("subject_pds")
+
+    indexes = {idx["name"] for idx in inspector.get_indexes("subject_pds")} if "subject_pds" in table_names else set()
+    study_index_name = op.f("ix_subject_pds_study_id")
+    if study_index_name not in indexes:
+        op.create_index(study_index_name, "subject_pds", ["study_id"], unique=False)
+
+    subject_index_name = op.f("ix_subject_pds_subject_id")
+    if subject_index_name not in indexes:
+        op.create_index(subject_index_name, "subject_pds", ["subject_id"], unique=False)
+
+
+def downgrade() -> None:
+    bind = op.get_bind()
+    inspector = sa.inspect(bind)
+    table_names = set(inspector.get_table_names())
+
+    if "subject_pds" in table_names:
+        indexes = {idx["name"] for idx in inspector.get_indexes("subject_pds")}
+        study_index_name = op.f("ix_subject_pds_study_id")
+        if study_index_name in indexes:
+            op.drop_index(study_index_name, table_name="subject_pds")
+
+        subject_index_name = op.f("ix_subject_pds_subject_id")
+        if subject_index_name in indexes:
+            op.drop_index(subject_index_name, table_name="subject_pds")
+
+        op.drop_table("subject_pds")

backend/app/api/v1/router.py

@@ -1,6 +1,6 @@
 from fastapi import APIRouter
 
-from app.api.v1 import auth, users, admin_users, studies, sites, members, attachments, audit_logs, dashboard, subjects, visits, aes, finance_dashboard, finance_contracts, finance_specials, fees_contracts, fees_specials, fees_attachments, drug_shipments, material_equipments, project_milestones, startup, knowledge_notes, subject_histories, faq_categories, faqs, documents, overview, notifications, monitoring_visit_issues
+from app.api.v1 import auth, users, admin_users, studies, sites, members, attachments, audit_logs, dashboard, subjects, visits, aes, finance_dashboard, finance_contracts, finance_specials, fees_contracts, fees_specials, fees_attachments, drug_shipments, material_equipments, project_milestones, startup, knowledge_notes, subject_histories, subject_pds, study_subject_pds, faq_categories, faqs, documents, overview, notifications, monitoring_visit_issues
 
 
 api_router = APIRouter()
@@ -32,6 +32,8 @@ api_router.include_router(startup.router, prefix="/studies/{study_id}/startup",
 api_router.include_router(knowledge_notes.router, prefix="/studies/{study_id}/knowledge", tags=["knowledge"])
 api_router.include_router(monitoring_visit_issues.router, prefix="/studies/{study_id}/monitoring", tags=["monitoring-visit-issues"])
 api_router.include_router(subject_histories.router, prefix="/studies/{study_id}/subjects/{subject_id}", tags=["subject-histories"])
+api_router.include_router(subject_pds.router, prefix="/studies/{study_id}/subjects/{subject_id}", tags=["subject-pds"])
+api_router.include_router(study_subject_pds.router, prefix="/studies/{study_id}", tags=["subject-pds"])
 api_router.include_router(faq_categories.router, prefix="/faqs/categories", tags=["faq-categories"])
 api_router.include_router(faqs.router, prefix="/faqs/items", tags=["faqs"])
 api_router.include_router(documents.router, prefix="", tags=["documents"])

backend/app/api/v1/study_subject_pds.py

@@ -0,0 +1,50 @@
+import uuid
+
+from fastapi import APIRouter, Depends, HTTPException, status
+from sqlalchemy.ext.asyncio import AsyncSession
+
+from app.core.deps import get_cra_site_scope, get_current_user, get_db_session, require_study_member
+from app.crud import study as study_crud
+from app.crud import subject_pd as subject_pd_crud
+from app.schemas.subject_pd import SubjectPdSummaryRead
+
+router = APIRouter()
+
+
+async def _ensure_study_exists(db: AsyncSession, study_id: uuid.UUID):
+    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")
+    return study
+
+
+@router.get(
+    "/subject-pds",
+    response_model=list[SubjectPdSummaryRead],
+    dependencies=[Depends(require_study_member())],
+)
+async def list_study_subject_pds(
+    study_id: uuid.UUID,
+    skip: int = 0,
+    limit: int = 500,
+    db: AsyncSession = Depends(get_db_session),
+    current_user=Depends(get_current_user),
+) -> list[SubjectPdSummaryRead]:
+    await _ensure_study_exists(db, study_id)
+    cra_scope = await get_cra_site_scope(db, study_id, current_user)
+    site_ids = cra_scope[0] if cra_scope else None
+    rows = await subject_pd_crud.list_study_subject_pds(db, study_id, skip=skip, limit=limit, site_ids=site_ids)
+    return [
+        SubjectPdSummaryRead(
+            id=item.id,
+            study_id=item.study_id,
+            subject_id=item.subject_id,
+            subject_no=subject_no,
+            site_id=site_id,
+            pd_no=item.pd_no,
+            status=item.status,
+            description=item.description,
+            updated_at=item.updated_at,
+        )
+        for item, subject_no, site_id in rows
+    ]

backend/app/api/v1/subject_pds.py

@@ -0,0 +1,206 @@
+import uuid
+
+from fastapi import APIRouter, Depends, HTTPException, status
+from sqlalchemy.ext.asyncio import AsyncSession
+
+from app.core.deps import (
+    get_current_user,
+    get_db_session,
+    require_study_member,
+    require_study_not_locked,
+    require_study_roles,
+)
+from app.crud import audit as audit_crud
+from app.crud import site as site_crud
+from app.crud import study as study_crud
+from app.crud import subject as subject_crud
+from app.crud import subject_pd as subject_pd_crud
+from app.schemas.subject_pd import SubjectPdCreate, SubjectPdRead, SubjectPdUpdate
+
+router = APIRouter()
+
+ALLOWED_PD_LEVELS = {"GENERAL", "MAJOR", "CRITICAL"}
+ALLOWED_APPROVAL_STATUS = {"DRAFT", "SUBMITTED", "APPROVED", "REJECTED"}
+ALLOWED_PD_STATUS = {"OPEN", "CLOSED"}
+
+
+async def _ensure_study_exists(db: AsyncSession, study_id: uuid.UUID):
+    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")
+    return study
+
+
+async def _ensure_subject(db: AsyncSession, study_id: uuid.UUID, subject_id: uuid.UUID):
+    subject = await subject_crud.get_subject(db, subject_id)
+    if not subject or subject.study_id != study_id:
+        raise HTTPException(status_code=status.HTTP_404_NOT_FOUND, detail="参与者不存在")
+    return subject
+
+
+async def _ensure_subject_active(db: AsyncSession, subject) -> None:
+    if not subject or not subject.site_id:
+        return
+    site = await site_crud.get_site(db, subject.site_id)
+    if not site or not site.is_active:
+        raise HTTPException(status_code=status.HTTP_403_FORBIDDEN, detail="中心已停用")
+
+
+def _normalize_pd_type(value: str) -> str:
+    normalized = str(value or "").strip()
+    if not normalized:
+        raise HTTPException(status_code=status.HTTP_400_BAD_REQUEST, detail="PD类型不能为空")
+    return normalized
+
+
+def _normalize_choice(value: str | None, allowed: set[str], field_name: str) -> str:
+    if value is None:
+        raise HTTPException(status_code=status.HTTP_400_BAD_REQUEST, detail=f"{field_name}不能为空")
+    normalized = str(value).strip().upper()
+    if normalized not in allowed:
+        raise HTTPException(status_code=status.HTTP_400_BAD_REQUEST, detail=f"{field_name}取值无效")
+    return normalized
+
+
+@router.get(
+    "/pds",
+    response_model=list[SubjectPdRead],
+    dependencies=[Depends(require_study_member())],
+)
+async def list_subject_pds(
+    study_id: uuid.UUID,
+    subject_id: uuid.UUID,
+    skip: int = 0,
+    limit: int = 200,
+    db: AsyncSession = Depends(get_db_session),
+) -> list[SubjectPdRead]:
+    await _ensure_study_exists(db, study_id)
+    await _ensure_subject(db, study_id, subject_id)
+    items = await subject_pd_crud.list_subject_pds(db, study_id, subject_id, skip=skip, limit=limit)
+    return [SubjectPdRead.model_validate(item) for item in items]
+
+
+@router.post(
+    "/pds",
+    response_model=SubjectPdRead,
+    status_code=status.HTTP_201_CREATED,
+    dependencies=[Depends(require_study_roles(["PM", "CRA"])), Depends(require_study_not_locked())],
+)
+async def create_subject_pd(
+    study_id: uuid.UUID,
+    subject_id: uuid.UUID,
+    pd_in: SubjectPdCreate,
+    db: AsyncSession = Depends(get_db_session),
+    current_user=Depends(get_current_user),
+) -> SubjectPdRead:
+    await _ensure_study_exists(db, study_id)
+    subject = await _ensure_subject(db, study_id, subject_id)
+    await _ensure_subject_active(db, subject)
+    if pd_in.subject_id != subject_id:
+        raise HTTPException(status_code=status.HTTP_400_BAD_REQUEST, detail="参与者不匹配")
+
+    payload = pd_in.model_dump()
+    payload["pd_type"] = _normalize_pd_type(payload.get("pd_type") or "")
+    payload["pd_level"] = _normalize_choice(payload.get("pd_level") or "GENERAL", ALLOWED_PD_LEVELS, "PD分级")
+    payload["approval_status"] = _normalize_choice(
+        payload.get("approval_status") or "DRAFT", ALLOWED_APPROVAL_STATUS, "审批状态"
+    )
+    payload["status"] = _normalize_choice(payload.get("status") or "OPEN", ALLOWED_PD_STATUS, "状态")
+
+    item = await subject_pd_crud.create_subject_pd(
+        db,
+        study_id,
+        SubjectPdCreate(**payload),
+        created_by=current_user.id,
+    )
+    await audit_crud.log_action(
+        db,
+        study_id=study_id,
+        entity_type="subject_pd",
+        entity_id=item.id,
+        action="CREATE_SUBJECT_PD",
+        detail=f"PD记录 {item.pd_no} 已创建",
+        operator_id=current_user.id,
+        operator_role=current_user.role,
+    )
+    return SubjectPdRead.model_validate(item)
+
+
+@router.patch(
+    "/pds/{pd_id}",
+    response_model=SubjectPdRead,
+    dependencies=[Depends(require_study_roles(["PM", "CRA"])), Depends(require_study_not_locked())],
+)
+async def update_subject_pd(
+    study_id: uuid.UUID,
+    subject_id: uuid.UUID,
+    pd_id: uuid.UUID,
+    pd_in: SubjectPdUpdate,
+    db: AsyncSession = Depends(get_db_session),
+    current_user=Depends(get_current_user),
+) -> SubjectPdRead:
+    await _ensure_study_exists(db, study_id)
+    subject = await _ensure_subject(db, study_id, subject_id)
+    await _ensure_subject_active(db, subject)
+
+    item = await subject_pd_crud.get_subject_pd(db, pd_id)
+    if not item or item.study_id != study_id or item.subject_id != subject_id:
+        raise HTTPException(status_code=status.HTTP_404_NOT_FOUND, detail="PD记录不存在")
+
+    update_payload = pd_in.model_dump(exclude_unset=True)
+    if "pd_type" in update_payload:
+        update_payload["pd_type"] = _normalize_pd_type(update_payload["pd_type"])
+    if "pd_level" in update_payload:
+        update_payload["pd_level"] = _normalize_choice(update_payload["pd_level"], ALLOWED_PD_LEVELS, "PD分级")
+    if "approval_status" in update_payload:
+        update_payload["approval_status"] = _normalize_choice(
+            update_payload["approval_status"], ALLOWED_APPROVAL_STATUS, "审批状态"
+        )
+    if "status" in update_payload:
+        update_payload["status"] = _normalize_choice(update_payload["status"], ALLOWED_PD_STATUS, "状态")
+
+    updated = await subject_pd_crud.update_subject_pd(db, item, SubjectPdUpdate(**update_payload))
+    await audit_crud.log_action(
+        db,
+        study_id=study_id,
+        entity_type="subject_pd",
+        entity_id=pd_id,
+        action="UPDATE_SUBJECT_PD",
+        detail=f"PD记录 {updated.pd_no} 已更新",
+        operator_id=current_user.id,
+        operator_role=current_user.role,
+    )
+    return SubjectPdRead.model_validate(updated)
+
+
+@router.delete(
+    "/pds/{pd_id}",
+    status_code=status.HTTP_204_NO_CONTENT,
+    dependencies=[Depends(require_study_roles(["PM", "CRA"])), Depends(require_study_not_locked())],
+)
+async def delete_subject_pd(
+    study_id: uuid.UUID,
+    subject_id: uuid.UUID,
+    pd_id: uuid.UUID,
+    db: AsyncSession = Depends(get_db_session),
+    current_user=Depends(get_current_user),
+) -> None:
+    await _ensure_study_exists(db, study_id)
+    subject = await _ensure_subject(db, study_id, subject_id)
+    await _ensure_subject_active(db, subject)
+
+    item = await subject_pd_crud.get_subject_pd(db, pd_id)
+    if not item or item.study_id != study_id or item.subject_id != subject_id:
+        raise HTTPException(status_code=status.HTTP_404_NOT_FOUND, detail="PD记录不存在")
+
+    await subject_pd_crud.delete_subject_pd(db, item)
+    await audit_crud.log_action(
+        db,
+        study_id=study_id,
+        entity_type="subject_pd",
+        entity_id=pd_id,
+        action="DELETE_SUBJECT_PD",
+        detail=f"PD记录 {item.pd_no} 已删除",
+        operator_id=current_user.id,
+        operator_role=current_user.role,
+    )

backend/app/crud/subject_pd.py

@@ -0,0 +1,120 @@
+import re
+import uuid
+from typing import Sequence
+
+from sqlalchemy import select, update as sa_update
+from sqlalchemy.ext.asyncio import AsyncSession
+
+from app.models.subject import Subject
+from app.models.subject_pd import SubjectPd
+from app.schemas.subject_pd import SubjectPdCreate, SubjectPdUpdate
+
+
+_PD_NO_PATTERN = re.compile(r"PD(\d+)$", re.IGNORECASE)
+
+
+def _extract_pd_sequence(pd_no: str | None) -> int:
+    if not pd_no:
+        return 0
+    matched = _PD_NO_PATTERN.search(str(pd_no).strip())
+    if not matched:
+        return 0
+    try:
+        return int(matched.group(1))
+    except ValueError:
+        return 0
+
+
+async def _next_pd_no(db: AsyncSession, study_id: uuid.UUID) -> str:
+    rows = await db.execute(select(SubjectPd.pd_no).where(SubjectPd.study_id == study_id))
+    max_seq = 0
+    for (pd_no,) in rows.all():
+        max_seq = max(max_seq, _extract_pd_sequence(pd_no))
+    return f"PD{max_seq + 1:04d}"
+
+
+async def list_subject_pds(
+    db: AsyncSession,
+    study_id: uuid.UUID,
+    subject_id: uuid.UUID,
+    *,
+    skip: int = 0,
+    limit: int = 200,
+) -> Sequence[SubjectPd]:
+    stmt = (
+        select(SubjectPd)
+        .where(SubjectPd.study_id == study_id, SubjectPd.subject_id == subject_id)
+        .order_by(SubjectPd.pd_no.asc(), SubjectPd.created_at.asc())
+        .offset(skip)
+        .limit(limit)
+    )
+    rows = await db.execute(stmt)
+    return rows.scalars().all()
+
+
+async def list_study_subject_pds(
+    db: AsyncSession,
+    study_id: uuid.UUID,
+    *,
+    skip: int = 0,
+    limit: int = 500,
+    site_ids: set[uuid.UUID] | None = None,
+) -> list[tuple[SubjectPd, str, uuid.UUID]]:
+    if site_ids is not None and not site_ids:
+        return []
+    stmt = (
+        select(SubjectPd, Subject.subject_no, Subject.site_id)
+        .join(Subject, Subject.id == SubjectPd.subject_id)
+        .where(
+            SubjectPd.study_id == study_id,
+            Subject.study_id == study_id,
+        )
+        .order_by(SubjectPd.pd_no.asc(), SubjectPd.created_at.asc())
+        .offset(skip)
+        .limit(limit)
+    )
+    if site_ids is not None:
+        stmt = stmt.where(Subject.site_id.in_(site_ids))
+    rows = await db.execute(stmt)
+    return [(row[0], row[1], row[2]) for row in rows.all()]
+
+
+async def get_subject_pd(db: AsyncSession, pd_id: uuid.UUID) -> SubjectPd | None:
+    row = await db.execute(select(SubjectPd).where(SubjectPd.id == pd_id))
+    return row.scalar_one_or_none()
+
+
+async def create_subject_pd(
+    db: AsyncSession,
+    study_id: uuid.UUID,
+    pd_in: SubjectPdCreate,
+    *,
+    created_by: uuid.UUID | None = None,
+) -> SubjectPd:
+    payload = pd_in.model_dump(exclude_unset=True)
+    # PD编号统一由后端按项目全局顺序生成，避免被外部覆盖。
+    payload.pop("pd_no", None)
+    pd_no = await _next_pd_no(db, study_id)
+    item = SubjectPd(study_id=study_id, pd_no=pd_no, created_by=created_by, **payload)
+    db.add(item)
+    await db.commit()
+    await db.refresh(item)
+    return item
+
+
+async def update_subject_pd(db: AsyncSession, item: SubjectPd, pd_in: SubjectPdUpdate) -> SubjectPd:
+    update_data = pd_in.model_dump(exclude_unset=True)
+    if update_data:
+        await db.execute(
+            sa_update(SubjectPd)
+            .where(SubjectPd.id == item.id)
+            .values(**update_data)
+        )
+        await db.commit()
+    await db.refresh(item)
+    return item
+
+
+async def delete_subject_pd(db: AsyncSession, item: SubjectPd) -> None:
+    await db.delete(item)
+    await db.commit()

backend/app/db/base.py

@@ -13,6 +13,7 @@ from app.models.distribution import Distribution  # noqa: F401
 from app.models.acknowledgement import Acknowledgement  # noqa: F401
 from app.models.milestone import Milestone  # noqa: F401
 from app.models.subject import Subject  # noqa: F401
+from app.models.subject_pd import SubjectPd  # noqa: F401
 from app.models.visit import Visit  # noqa: F401
 from app.models.ae import AdverseEvent  # noqa: F401
 from app.models.finance import FinanceItem  # noqa: F401

backend/app/models/subject_pd.py

@@ -0,0 +1,28 @@
+import uuid
+from datetime import datetime
+
+from sqlalchemy import DateTime, ForeignKey, String, Text, UniqueConstraint, func
+from sqlalchemy.dialects.postgresql import UUID
+from sqlalchemy.orm import Mapped, mapped_column
+
+from app.db.base_class import Base
+
+
+class SubjectPd(Base):
+    __tablename__ = "subject_pds"
+    __table_args__ = (UniqueConstraint("study_id", "pd_no", name="uq_subject_pds_study_pd_no"),)
+
+    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)
+    subject_id: Mapped[uuid.UUID] = mapped_column(UUID(as_uuid=True), ForeignKey("subjects.id"), index=True, nullable=False)
+    pd_no: Mapped[str] = mapped_column(String(64), nullable=False)
+    pd_type: Mapped[str] = mapped_column(String(100), nullable=False)
+    pd_level: Mapped[str] = mapped_column(String(20), nullable=False, server_default="GENERAL")
+    approval_status: Mapped[str] = mapped_column(String(20), nullable=False, server_default="DRAFT")
+    description: Mapped[str | None] = mapped_column(Text, nullable=True)
+    status: Mapped[str] = mapped_column(String(20), nullable=False, server_default="OPEN")
+    created_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/schemas/subject_pd.py

@@ -0,0 +1,52 @@
+import uuid
+from datetime import datetime
+from typing import Optional
+
+from pydantic import BaseModel, ConfigDict
+
+
+class SubjectPdCreate(BaseModel):
+    subject_id: uuid.UUID
+    pd_no: Optional[str] = None
+    pd_type: str
+    pd_level: Optional[str] = "GENERAL"
+    approval_status: Optional[str] = "DRAFT"
+    description: Optional[str] = None
+    status: Optional[str] = "OPEN"
+
+
+class SubjectPdUpdate(BaseModel):
+    pd_type: Optional[str] = None
+    pd_level: Optional[str] = None
+    approval_status: Optional[str] = None
+    description: Optional[str] = None
+    status: Optional[str] = None
+
+
+class SubjectPdRead(BaseModel):
+    id: uuid.UUID
+    study_id: uuid.UUID
+    subject_id: uuid.UUID
+    pd_no: str
+    pd_type: str
+    pd_level: str
+    approval_status: str
+    description: Optional[str]
+    status: str
+    created_by: Optional[uuid.UUID]
+    created_at: datetime
+    updated_at: datetime
+
+    model_config = ConfigDict(from_attributes=True)
+
+
+class SubjectPdSummaryRead(BaseModel):
+    id: uuid.UUID
+    study_id: uuid.UUID
+    subject_id: uuid.UUID
+    subject_no: str
+    site_id: uuid.UUID
+    pd_no: str
+    status: str
+    description: Optional[str]
+    updated_at: datetime

database/init.sql

@@ -135,6 +135,25 @@ CREATE TABLE IF NOT EXISTS public.subject_histories (
     CONSTRAINT fk_subject_histories_created_by FOREIGN KEY (created_by) REFERENCES public.users(id) ON DELETE RESTRICT
 );
 
+CREATE TABLE IF NOT EXISTS public.subject_pds (
+    id uuid PRIMARY KEY,
+    study_id uuid NOT NULL,
+    subject_id uuid NOT NULL,
+    pd_no character varying(64) NOT NULL,
+    pd_type character varying(100) NOT NULL,
+    pd_level character varying(20) NOT NULL DEFAULT 'GENERAL',
+    approval_status character varying(20) NOT NULL DEFAULT 'DRAFT',
+    description text,
+    status character varying(20) NOT NULL DEFAULT 'OPEN',
+    created_by uuid,
+    created_at timestamp with time zone NOT NULL DEFAULT now(),
+    updated_at timestamp with time zone NOT NULL DEFAULT now(),
+    CONSTRAINT uq_subject_pds_study_pd_no UNIQUE (study_id, pd_no),
+    CONSTRAINT fk_subject_pds_study_id FOREIGN KEY (study_id) REFERENCES public.studies(id) ON DELETE RESTRICT,
+    CONSTRAINT fk_subject_pds_subject_id FOREIGN KEY (subject_id) REFERENCES public.subjects(id) ON DELETE RESTRICT,
+    CONSTRAINT fk_subject_pds_created_by FOREIGN KEY (created_by) REFERENCES public.users(id) ON DELETE RESTRICT
+);
+
 CREATE TABLE IF NOT EXISTS public.visits (
     id uuid PRIMARY KEY,
     study_id uuid NOT NULL,
@@ -749,6 +768,61 @@ ON CONFLICT (study_id, subject_no) DO UPDATE SET
     drop_reason = EXCLUDED.drop_reason,
     updated_at = EXCLUDED.updated_at;
 
+INSERT INTO public.subject_pds (
+    id, study_id, subject_id, pd_no, pd_type, pd_level, approval_status, description, status, created_by, created_at, updated_at
+) VALUES
+    (
+        '77777777-aaaa-bbbb-cccc-111111111111',
+        (SELECT id FROM public.studies WHERE code = 'DEMO-CTMS'),
+        '11111111-2222-3333-4444-555555555555',
+        'PD0001',
+        '知情同意',
+        'MAJOR',
+        'DRAFT',
+        '知情记录不完整，缺少签署时间记录。',
+        'OPEN',
+        (SELECT id FROM public.users WHERE email = 'cra@example.com'),
+        '2025-01-11 10:00:00+00',
+        '2025-01-11 10:00:00+00'
+    ),
+    (
+        '77777777-aaaa-bbbb-cccc-222222222222',
+        (SELECT id FROM public.studies WHERE code = 'DEMO-CTMS'),
+        '11111111-2222-3333-4444-555555555555',
+        'PD0002',
+        '排除标准',
+        'CRITICAL',
+        'APPROVED',
+        '排除标准判定延期，已补充说明并审批通过。',
+        'OPEN',
+        (SELECT id FROM public.users WHERE email = 'cra@example.com'),
+        '2025-01-18 10:00:00+00',
+        '2025-01-19 09:00:00+00'
+    ),
+    (
+        '77777777-aaaa-bbbb-cccc-333333333333',
+        (SELECT id FROM public.studies WHERE code = 'DEMO-CTMS'),
+        '33333333-4444-5555-6666-777777777777',
+        'PD0003',
+        '访视流程',
+        'GENERAL',
+        'SUBMITTED',
+        '访视窗口外补录，已提交审批。',
+        'CLOSED',
+        (SELECT id FROM public.users WHERE email = 'pm@example.com'),
+        '2025-02-06 10:00:00+00',
+        '2025-02-06 10:00:00+00'
+    )
+ON CONFLICT (study_id, pd_no) DO UPDATE SET
+    subject_id = EXCLUDED.subject_id,
+    pd_type = EXCLUDED.pd_type,
+    pd_level = EXCLUDED.pd_level,
+    approval_status = EXCLUDED.approval_status,
+    description = EXCLUDED.description,
+    status = EXCLUDED.status,
+    created_by = EXCLUDED.created_by,
+    updated_at = EXCLUDED.updated_at;
+
 INSERT INTO public.subject_histories (
     id, study_id, subject_id, record_date, content, created_by, created_at, updated_at
 ) VALUES

frontend/src/api/subjectPds.ts

@@ -0,0 +1,20 @@
+import { apiDelete, apiGet, apiPatch, apiPost } from "./axios";
+
+export const listStudySubjectPds = (studyId: string, params?: Record<string, any>) =>
+  apiGet(`/api/v1/studies/${studyId}/subject-pds`, { params });
+
+export const listSubjectPds = (studyId: string, subjectId: string, params?: Record<string, any>) =>
+  apiGet(`/api/v1/studies/${studyId}/subjects/${subjectId}/pds`, { params });
+
+export const createSubjectPd = (studyId: string, subjectId: string, payload: Record<string, any>) =>
+  apiPost(`/api/v1/studies/${studyId}/subjects/${subjectId}/pds`, payload);
+
+export const updateSubjectPd = (
+  studyId: string,
+  subjectId: string,
+  pdId: string,
+  payload: Record<string, any>
+) => apiPatch(`/api/v1/studies/${studyId}/subjects/${subjectId}/pds/${pdId}`, payload);
+
+export const deleteSubjectPd = (studyId: string, subjectId: string, pdId: string) =>
+  apiDelete(`/api/v1/studies/${studyId}/subjects/${subjectId}/pds/${pdId}`);

frontend/src/locales/zh-CN.ts

@@ -149,6 +149,7 @@ export const TEXT = {
       approvedDate: "批准日期",
       meetingDate: "会议日期",
       approvalNo: "批件号",
+      approvalStatus: "审批状态",
       projectNo: "项目编号",
       kickoffDate: "启动会日期",
       attendees: "参训人员",
@@ -175,6 +176,10 @@ export const TEXT = {
       signedDate: "签署日期",
       currency: "币种",
       currencyDefault: "CNY",
+      pdNo: "PD 编号",
+      pdType: "PD 类型",
+      pdLevel: "PD 分级",
+      pdDescription: "PD 描述",
       remark: "备注",
     },
     empty: {
@@ -670,9 +675,12 @@ export const TEXT = {
       emptyVisits: "暂无访视记录",
       emptyAe: "暂无 AE 记录",
       emptyPd: "暂无 PD 记录",
+      newPd: "新增 PD",
       dialogHistory: "病史记录",
       dialogVisit: "访视记录",
       dialogAe: "AE 记录",
+      dialogPd: "PD 记录",
+      pdNoAuto: "保存后自动生成",
     },
     riskIssues: {
       title: "风险问题",
@@ -692,7 +700,7 @@ export const TEXT = {
       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",
+      emptyDescription: "暂无 PD 记录",
       syncStatus: "同步状态",
       synced: "已同步",
       toSubject: "查看参与者",
@@ -1136,6 +1144,21 @@ export const TEXT = {
       PROCESSING: "处理中",
       RESOLVED: "已解决",
     },
+    pdLevel: {
+      GENERAL: "一般",
+      MAJOR: "重大",
+      CRITICAL: "严重",
+    },
+    pdApprovalStatus: {
+      DRAFT: "未提交",
+      SUBMITTED: "审批中",
+      APPROVED: "通过",
+      REJECTED: "驳回",
+    },
+    pdStatus: {
+      OPEN: "开放",
+      CLOSED: "关闭",
+    },
     generalStatus: {
       TODO: "待处理",
       DOING: "进行中",

frontend/src/views/admin/ProjectDetail.vue

@@ -36,8 +36,8 @@
           </div>
           <div class="setup-view-mode">
             <el-radio-group v-model="setupViewMode" size="small">
-              <el-radio-button label="draft">草稿视图</el-radio-button>
+              <el-radio-button label="draft">草稿</el-radio-button>
-              <el-radio-button label="published">发布预览</el-radio-button>
+              <el-radio-button label="published">预览</el-radio-button>
             </el-radio-group>
           </div>
         </div>
@@ -3623,7 +3623,7 @@ const startEdit = () => {
   if (!project.value) return;
   if (activeStep.value !== 0 && activeStep.value !== 2 && activeStep.value !== 4) return;
   if (isPublishedView.value) {
-    ElMessage.info("当前为发布预览，请先切换到草稿视图后再编辑");
+    ElMessage.info("当前为预览，请先切换到草稿后再编辑");
     return;
   }
   if (!canManageSetup.value) {
@@ -4128,7 +4128,7 @@ const addProjectMilestone = () => {
 const ensureStep2Editable = (): boolean => {
   if (!project.value) return false;
   if (isPublishedView.value) {
-    ElMessage.info("当前为发布预览，请先切换到草稿视图后再操作");
+    ElMessage.info("当前为预览，请先切换到草稿后再操作");
     return false;
   }
   if (!canManageSetup.value) {

frontend/src/views/ia/RiskIssuePd.vue

@@ -4,7 +4,7 @@
       <div class="filter-container unified-action-bar">
         <el-form :inline="true" class="filter-form">
           <el-form-item class="filter-item-form">
-            <el-input v-model="filters.keyword" :placeholder="TEXT.modules.subjectManagement.screeningNo" clearable class="filter-input-comp">
+            <el-input v-model="filters.keyword" :placeholder="TEXT.common.fields.keyword" clearable class="filter-input-comp">
               <template #prefix>
                 <el-icon><Search /></el-icon>
               </template>
@@ -34,29 +34,20 @@
         </el-form>
       </div>
       <div class="unified-section table-section">
-        <el-table :data="filteredItems" v-loading="loading" style="width: 100%">
+        <el-table :data="filteredItems" v-loading="loading" style="width: 100%" table-layout="fixed">
-          <el-table-column prop="subject_no" :label="TEXT.modules.subjectManagement.screeningNo" min-width="160" />
+          <el-table-column prop="pd_no" :label="TEXT.common.fields.pdNo" min-width="160" show-overflow-tooltip />
-          <el-table-column :label="TEXT.common.fields.site" min-width="160">
+          <el-table-column prop="subject_no" :label="TEXT.modules.subjectManagement.screeningNo" min-width="160" show-overflow-tooltip />
+          <el-table-column :label="TEXT.common.fields.site" min-width="160" show-overflow-tooltip>
             <template #default="scope">{{ siteMap[scope.row.site_id] || TEXT.common.fallback }}</template>
           </el-table-column>
-          <el-table-column prop="status" :label="TEXT.common.fields.status" width="120">
+          <el-table-column prop="status" :label="TEXT.common.fields.status" min-width="160">
-            <template #default="scope">{{ displayEnum(TEXT.enums.subjectStatus, scope.row.status) }}</template>
+            <template #default="scope">{{ displayEnum(TEXT.enums.pdStatus, scope.row.status) }}</template>
           </el-table-column>
-          <el-table-column prop="enrollment_date" :label="TEXT.common.fields.enrollmentDate" width="140">
+          <el-table-column prop="description" :label="TEXT.common.fields.pdDescription" min-width="160" show-overflow-tooltip />
-            <template #default="scope">{{ displayDate(scope.row.enrollment_date) }}</template>
+          <el-table-column :label="TEXT.common.labels.actions" min-width="160" align="center">
-          </el-table-column>
-          <el-table-column prop="updated_at" :label="TEXT.common.labels.updatedAt" min-width="180">
-            <template #default="scope">{{ displayDate(scope.row.updated_at) }}</template>
-          </el-table-column>
-          <el-table-column :label="TEXT.modules.riskIssuePd.syncStatus" width="120">
-            <template #default>
-              <el-tag size="small" type="success" effect="plain">{{ TEXT.modules.riskIssuePd.synced }}</el-tag>
-            </template>
-          </el-table-column>
-          <el-table-column :label="TEXT.common.labels.actions" width="120">
             <template #default="scope">
-              <el-button link type="primary" size="small" @click="goSubject(scope.row.id)">
+              <el-button link type="primary" size="small" @click="goSubject(scope.row.subject_id)">
-                {{ TEXT.modules.riskIssuePd.toSubject }}
+                {{ TEXT.common.actions.view }}
               </el-button>
             </template>
           </el-table-column>
@@ -73,9 +64,9 @@ import { useRouter } from "vue-router";
 import { ElMessage } from "element-plus";
 import { CircleCheck, Location, Search } from "@element-plus/icons-vue";
 import { useStudyStore } from "../../store/study";
-import { fetchSubjects } from "../../api/subjects";
+import { listStudySubjectPds } from "../../api/subjectPds";
 import { fetchSites } from "../../api/sites";
-import { displayDate, displayEnum } from "../../utils/display";
+import { displayEnum } from "../../utils/display";
 import StateEmpty from "../../components/StateEmpty.vue";
 import { TEXT } from "../../locales";
 
@@ -91,7 +82,7 @@ const filters = ref({
   status: "",
 });
 
-const statusOptions = Object.entries(TEXT.enums.subjectStatus).map(([value, label]) => ({ value, label }));
+const statusOptions = Object.entries(TEXT.enums.pdStatus).map(([value, label]) => ({ value, label }));
 
 const resetFilters = () => {
   filters.value.keyword = "";
@@ -120,10 +111,16 @@ const load = async () => {
   loading.value = true;
   try {
     await loadSites(studyId);
-    const { data } = await fetchSubjects(studyId);
+    const { data } = await listStudySubjectPds(studyId);
-    items.value = (Array.isArray(data) ? data : data.items || []).sort((a: any, b: any) =>
+    const list = Array.isArray(data) ? data : data.items || [];
-      String(b.updated_at || "").localeCompare(String(a.updated_at || ""))
+    const getPdSeq = (pdNo: string) => {
-    );
+      const text = String(pdNo || "");
+      const matched = text.match(/^PD(\d+)$/i);
+      if (!matched) return Number.POSITIVE_INFINITY;
+      const num = Number(matched[1]);
+      return Number.isFinite(num) ? num : Number.POSITIVE_INFINITY;
+    };
+    items.value = list.sort((a: any, b: any) => getPdSeq(a?.pd_no) - getPdSeq(b?.pd_no));
   } catch (e: any) {
     ElMessage.error(e?.response?.data?.message || TEXT.common.messages.loadFailed);
   } finally {
@@ -134,8 +131,10 @@ const load = async () => {
 const filteredItems = computed(() => {
   const keyword = filters.value.keyword.trim().toLowerCase();
   return items.value.filter((item) => {
+    const pdNo = String(item?.pd_no || "").toLowerCase();
     const subjectNo = String(item?.subject_no || "").toLowerCase();
-    if (keyword && !subjectNo.includes(keyword)) return false;
+    const description = String(item?.description || "").toLowerCase();
+    if (keyword && !pdNo.includes(keyword) && !subjectNo.includes(keyword) && !description.includes(keyword)) return false;
     if (filters.value.siteId && item?.site_id !== filters.value.siteId) return false;
     if (filters.value.status && item?.status !== filters.value.status) return false;
     return true;

frontend/src/views/subjects/SubjectDetail.vue

@@ -253,7 +253,47 @@
         </el-tab-pane>
 
         <el-tab-pane :label="TEXT.modules.subjectDetail.tabs.pd" name="pd">
-          <StateEmpty :description="TEXT.modules.subjectDetail.emptyPd" />
+          <div class="tab-actions">
+            <el-button type="primary" :disabled="isReadOnly" @click="openPdDialog()">
+              {{ TEXT.modules.subjectDetail.newPd }}
+            </el-button>
+          </div>
+          <el-table :data="pdItems" v-loading="loadingPds" style="width: 100%">
+            <el-table-column prop="pd_no" :label="TEXT.common.fields.pdNo" width="130" />
+            <el-table-column prop="pd_type" :label="TEXT.common.fields.pdType" min-width="140" />
+            <el-table-column prop="pd_level" :label="TEXT.common.fields.pdLevel" min-width="120">
+              <template #default="scope">{{ displayEnum(TEXT.enums.pdLevel, scope.row.pd_level) }}</template>
+            </el-table-column>
+            <el-table-column prop="description" :label="TEXT.common.fields.pdDescription" min-width="240">
+              <template #default="scope">{{ scope.row.description || TEXT.common.fallback }}</template>
+            </el-table-column>
+            <el-table-column prop="status" :label="TEXT.common.fields.status" min-width="100">
+              <template #default="scope">{{ displayEnum(TEXT.enums.pdStatus, scope.row.status) }}</template>
+            </el-table-column>
+            <el-table-column :label="TEXT.common.labels.actions" width="150">
+              <template #default="scope">
+                <el-button
+                  link
+                  type="primary"
+                  size="small"
+                  :disabled="isReadOnly"
+                  @click="openPdDialog(scope.row)"
+                >
+                  {{ TEXT.common.actions.edit }}
+                </el-button>
+                <el-button
+                  link
+                  type="danger"
+                  size="small"
+                  :disabled="isReadOnly"
+                  @click="removePd(scope.row)"
+                >
+                  {{ TEXT.common.actions.delete }}
+                </el-button>
+              </template>
+            </el-table-column>
+          </el-table>
+          <StateEmpty v-if="!loadingPds && pdItems.length === 0" :description="TEXT.modules.subjectDetail.emptyPd" />
         </el-tab-pane>
       </el-tabs>
     </el-card>
@@ -342,6 +382,36 @@
         <el-button type="primary" :disabled="isReadOnly" @click="saveAe">{{ TEXT.common.actions.save }}</el-button>
       </template>
     </el-dialog>
+
+    <el-dialog append-to=".layout-main .content-wrapper" v-model="pdDialogVisible" :title="TEXT.modules.subjectDetail.dialogPd" width="560px">
+      <el-form :model="pdForm" label-width="100px">
+        <el-form-item :label="TEXT.common.fields.pdNo">
+          <el-input v-model="pdForm.pd_no" disabled :placeholder="TEXT.modules.subjectDetail.pdNoAuto" />
+        </el-form-item>
+        <el-form-item :label="TEXT.common.fields.pdType" required>
+          <el-select v-model="pdForm.pd_type" filterable allow-create default-first-option clearable>
+            <el-option v-for="item in pdTypeOptions" :key="item" :label="item" :value="item" />
+          </el-select>
+        </el-form-item>
+        <el-form-item :label="TEXT.common.fields.pdLevel" required>
+          <el-select v-model="pdForm.pd_level">
+            <el-option v-for="option in pdLevelOptions" :key="option.value" :label="option.label" :value="option.value" />
+          </el-select>
+        </el-form-item>
+        <el-form-item :label="TEXT.common.fields.status" required>
+          <el-select v-model="pdForm.status">
+            <el-option v-for="option in pdStatusOptions" :key="option.value" :label="option.label" :value="option.value" />
+          </el-select>
+        </el-form-item>
+        <el-form-item :label="TEXT.common.fields.pdDescription">
+          <el-input v-model="pdForm.description" type="textarea" :rows="3" />
+        </el-form-item>
+      </el-form>
+      <template #footer>
+        <el-button @click="pdDialogVisible = false">{{ TEXT.common.actions.cancel }}</el-button>
+        <el-button type="primary" :disabled="isReadOnly" @click="savePd">{{ TEXT.common.actions.save }}</el-button>
+      </template>
+    </el-dialog>
   </div>
 </template>
 
@@ -355,6 +425,7 @@ import { fetchSites } from "../../api/sites";
 import { listSubjectHistories, createSubjectHistory, updateSubjectHistory, deleteSubjectHistory } from "../../api/subjectHistories";
 import { fetchVisits, createVisit, updateVisit, deleteVisit } from "../../api/visits";
 import { fetchAes, createAe, updateAe, deleteAe } from "../../api/aes";
+import { listSubjectPds, createSubjectPd, updateSubjectPd, deleteSubjectPd } from "../../api/subjectPds";
 import { displayDate, displayEnum, displayText } from "../../utils/display";
 import StateEmpty from "../../components/StateEmpty.vue";
 import { TEXT } from "../../locales";
@@ -461,6 +532,22 @@ const aeSeriousnessOptions = [
   { value: "IV", label: TEXT.enums.aeSeriousness.IV },
   { value: "V", label: TEXT.enums.aeSeriousness.V },
 ];
+
+const pdItems = ref<any[]>([]);
+const loadingPds = ref(false);
+const pdDialogVisible = ref(false);
+const pdEditingId = ref<string | null>(null);
+const pdTypeOptions = ["知情同意", "排除标准", "药物使用", "入排标准", "访视流程", "检验检查", "其他"];
+const pdLevelOptions = Object.entries(TEXT.enums.pdLevel).map(([value, label]) => ({ value, label }));
+const pdStatusOptions = Object.entries(TEXT.enums.pdStatus).map(([value, label]) => ({ value, label }));
+const pdForm = reactive({
+  pd_no: "",
+  pd_type: "",
+  pd_level: "GENERAL",
+  description: "",
+  status: "OPEN",
+});
+
 const normalizeSeriousness = (value?: string | null) => {
   if (!value) return "I";
   const normalized = String(value).trim().toUpperCase();
@@ -905,6 +992,88 @@ const removeAe = async (row: any) => {
   }
 };
 
+const loadPds = async () => {
+  if (!studyId || !subjectId) return;
+  loadingPds.value = true;
+  try {
+    const { data } = (await listSubjectPds(studyId, subjectId)) as any;
+    const list = Array.isArray(data) ? data : data.items || [];
+    const getPdSeq = (pdNo: string) => {
+      const text = String(pdNo || "");
+      const matched = text.match(/^PD(\d+)$/i);
+      if (!matched) return Number.POSITIVE_INFINITY;
+      const num = Number(matched[1]);
+      return Number.isFinite(num) ? num : Number.POSITIVE_INFINITY;
+    };
+    pdItems.value = list.sort((a: any, b: any) => getPdSeq(a?.pd_no) - getPdSeq(b?.pd_no));
+  } catch (e: any) {
+    ElMessage.error(e?.response?.data?.message || TEXT.common.messages.loadFailed);
+  } finally {
+    loadingPds.value = false;
+  }
+};
+
+const openPdDialog = (row?: any) => {
+  if (isReadOnly.value) {
+    ElMessage.warning("中心已停用");
+    return;
+  }
+  pdEditingId.value = row?.id || null;
+  Object.assign(pdForm, {
+    pd_no: row?.pd_no || "",
+    pd_type: row?.pd_type || "",
+    pd_level: row?.pd_level || "GENERAL",
+    description: row?.description || "",
+    status: row?.status || "OPEN",
+  });
+  pdDialogVisible.value = true;
+};
+
+const savePd = async () => {
+  if (isReadOnly.value) {
+    ElMessage.warning("中心已停用");
+    return;
+  }
+  if (!studyId || !subjectId) return;
+  if (!pdForm.pd_type?.trim()) {
+    ElMessage.error(TEXT.common.messages.required);
+    return;
+  }
+  try {
+    const basePayload = {
+      pd_type: pdForm.pd_type.trim(),
+      pd_level: pdForm.pd_level,
+      description: pdForm.description?.trim() || null,
+      status: pdForm.status,
+    };
+    if (pdEditingId.value) {
+      await updateSubjectPd(studyId, subjectId, pdEditingId.value, basePayload);
+    } else {
+      await createSubjectPd(studyId, subjectId, { subject_id: subjectId, ...basePayload });
+    }
+    pdDialogVisible.value = false;
+    loadPds();
+  } catch (e: any) {
+    ElMessage.error(e?.response?.data?.message || TEXT.common.messages.saveFailed);
+  }
+};
+
+const removePd = async (row: any) => {
+  if (isReadOnly.value) {
+    ElMessage.warning("中心已停用");
+    return;
+  }
+  if (!studyId || !subjectId) return;
+  const ok = await ElMessageBox.confirm(TEXT.common.confirm.delete, TEXT.common.labels.tips).catch(() => null);
+  if (!ok) return;
+  try {
+    await deleteSubjectPd(studyId, subjectId, row.id);
+    loadPds();
+  } catch (e: any) {
+    ElMessage.error(e?.response?.data?.message || TEXT.common.messages.deleteFailed);
+  }
+};
+
 const goBack = () => router.push("/subjects");
 
 watch(
@@ -920,6 +1089,7 @@ onMounted(async () => {
   loadHistories();
   loadVisits();
   loadAes();
+  loadPds();
 });
 </script>