立项配置页初步优化

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())