Step 7：AE + 风险/问题管理（PV）

2025-12-16 17:55:53 +08:00
parent c77b20f932
commit f19faf1a1a
63 changed files with 707 additions and 1 deletions
@@ -0,0 +1,164 @@
+import uuid
+from datetime import date
+
+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
+from app.crud import ae as ae_crud
+from app.crud import audit as audit_crud
+from app.crud import member as member_crud
+from app.crud import study as study_crud
+from app.schemas.ae import AECreate, AERead, AEUpdate
+
+router = APIRouter()
+
+ALLOWED_CREATE_ROLES = {"PM", "CRA", "PV"}
+ALLOWED_UPDATE_ROLES = {"PM", "PV"}
+
+
+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="Study not found")
+    return study
+
+
+async def _get_member_role(db: AsyncSession, study_id: uuid.UUID, user_id: uuid.UUID) -> str | None:
+    member = await member_crud.get_member(db, study_id, user_id)
+    return member.role_in_study if member else None
+
+
+def _is_overdue(ae: AERead) -> bool:
+    return bool(ae.report_due_date and date.today() > ae.report_due_date and ae.status != "CLOSED")
+
+
+@router.post(
+    "/",
+    response_model=AERead,
+    status_code=status.HTTP_201_CREATED,
+    dependencies=[Depends(require_study_member())],
+)
+async def create_ae(
+    study_id: uuid.UUID,
+    ae_in: AECreate,
+    db: AsyncSession = Depends(get_db_session),
+    current_user=Depends(get_current_user),
+) -> AERead:
+    await _ensure_study_exists(db, study_id)
+    member_role = await _get_member_role(db, study_id, current_user.id)
+    if current_user.role != "ADMIN" and member_role not in ALLOWED_CREATE_ROLES:
+        raise HTTPException(status_code=status.HTTP_403_FORBIDDEN, detail="Insufficient permissions")
+    try:
+        ae = await ae_crud.create_ae(db, study_id, ae_in, created_by=current_user.id)
+    except ValueError as exc:
+        raise HTTPException(status_code=status.HTTP_400_BAD_REQUEST, detail=str(exc)) from exc
+    await audit_crud.log_action(
+        db,
+        study_id=study_id,
+        entity_type="ae",
+        entity_id=ae.id,
+        action="CREATE_AE",
+        detail=f"AE {ae.id} created",
+        operator_id=current_user.id,
+        operator_role=current_user.role,
+    )
+    data = AERead.model_validate(ae)
+    data.is_overdue = _is_overdue(data)
+    return data
+
+
+@router.get(
+    "/",
+    response_model=list[AERead],
+    dependencies=[Depends(require_study_member())],
+)
+async def list_ae(
+    study_id: uuid.UUID,
+    status_filter: str | None = None,
+    seriousness: str | None = None,
+    site_id: uuid.UUID | None = None,
+    subject_id: uuid.UUID | None = None,
+    overdue: bool | None = None,
+    db: AsyncSession = Depends(get_db_session),
+) -> list[AERead]:
+    await _ensure_study_exists(db, study_id)
+    aes = await ae_crud.list_ae(db, study_id, status=status_filter, seriousness=seriousness, site_id=site_id, subject_id=subject_id, overdue=overdue)
+    result: list[AERead] = []
+    for item in aes:
+        obj = AERead.model_validate(item)
+        obj.is_overdue = _is_overdue(obj)
+        result.append(obj)
+    return result
+
+
+@router.get(
+    "/{ae_id}",
+    response_model=AERead,
+    dependencies=[Depends(require_study_member())],
+)
+async def get_ae(
+    study_id: uuid.UUID,
+    ae_id: uuid.UUID,
+    db: AsyncSession = Depends(get_db_session),
+) -> AERead:
+    await _ensure_study_exists(db, study_id)
+    ae = await ae_crud.get_ae(db, ae_id)
+    if not ae or ae.study_id != study_id:
+        raise HTTPException(status_code=status.HTTP_404_NOT_FOUND, detail="AE not found")
+    data = AERead.model_validate(ae)
+    data.is_overdue = _is_overdue(data)
+    return data
+
+
+@router.patch(
+    "/{ae_id}",
+    response_model=AERead,
+    dependencies=[Depends(require_study_member())],
+)
+async def update_ae(
+    study_id: uuid.UUID,
+    ae_id: uuid.UUID,
+    ae_in: AEUpdate,
+    db: AsyncSession = Depends(get_db_session),
+    current_user=Depends(get_current_user),
+) -> AERead:
+    await _ensure_study_exists(db, study_id)
+    ae = await ae_crud.get_ae(db, ae_id)
+    if not ae or ae.study_id != study_id:
+        raise HTTPException(status_code=status.HTTP_404_NOT_FOUND, detail="AE not found")
+
+    member_role = await _get_member_role(db, study_id, current_user.id)
+    if current_user.role == "ADMIN":
+        pass
+    elif member_role in ALLOWED_UPDATE_ROLES:
+        pass
+    elif member_role == "CRA":
+        if ae.created_by != current_user.id:
+            raise HTTPException(status_code=status.HTTP_403_FORBIDDEN, detail="Only creator can update AE")
+        if ae_in.status == "CLOSED":
+            raise HTTPException(status_code=status.HTTP_403_FORBIDDEN, detail="CRA cannot close AE")
+    else:
+        raise HTTPException(status_code=status.HTTP_403_FORBIDDEN, detail="Insufficient permissions")
+
+    old_status = ae.status
+    updated = await ae_crud.update_ae(db, ae, ae_in)
+
+    detail = None
+    action = "UPDATE_AE"
+    if ae_in.status and ae_in.status != old_status:
+        detail = f"AE {ae_id} status {old_status} -> {ae_in.status}"
+        action = "AE_STATUS_CHANGE"
+    await audit_crud.log_action(
+        db,
+        study_id=study_id,
+        entity_type="ae",
+        entity_id=ae_id,
+        action=action,
+        detail=detail or "AE updated",
+        operator_id=current_user.id,
+        operator_role=current_user.role,
+    )
+    data = AERead.model_validate(updated)
+    data.is_overdue = _is_overdue(data)
+    return data