参与者管理- PD模块内容补充

2026-02-28 14:33:57 +08:00
parent af0c1b4b7d
commit 9b36a42e6f
14 changed files with 855 additions and 35 deletions
@@ -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"])
@@ -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
+    ]
@@ -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,
+    )