Cheng Zhou
305 lines
10 KiB
Python
305 lines
10 KiB
Python
import json
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import uuid
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from datetime import date
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from fastapi import APIRouter, Depends, HTTPException, status
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from sqlalchemy.ext.asyncio import AsyncSession
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from app.core.deps import get_operator_role_label, get_cra_site_scope, get_current_user, get_db_session, require_study_not_locked, require_api_permission
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from app.crud import ae as ae_crud
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from app.crud import audit as audit_crud
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from app.crud import member as member_crud
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from app.crud import site as site_crud
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from app.crud import subject as subject_crud
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from app.crud import study as study_crud
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from app.schemas.ae import AECreate, AERead, AEUpdate
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router = APIRouter()
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async def _ensure_study_exists(db: AsyncSession, study_id: uuid.UUID):
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study = await study_crud.get(db, study_id)
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if not study:
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raise HTTPException(status_code=status.HTTP_404_NOT_FOUND, detail="项目不存在")
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return study
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async def _ensure_ae_visible(db: AsyncSession, study_id: uuid.UUID, ae: AERead | None):
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if not ae:
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raise HTTPException(status_code=status.HTTP_404_NOT_FOUND, detail="AE 不存在")
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if ae.site_id:
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site = await site_crud.get_site(db, ae.site_id)
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if not site or site.study_id != study_id or not site.is_active:
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raise HTTPException(status_code=status.HTTP_404_NOT_FOUND, detail="AE 不存在")
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if ae.subject_id:
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subject = await subject_crud.get_subject(db, ae.subject_id)
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if not subject or subject.study_id != study_id:
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raise HTTPException(status_code=status.HTTP_404_NOT_FOUND, detail="AE 不存在")
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site = await site_crud.get_site(db, subject.site_id)
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if not site or not site.is_active:
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raise HTTPException(status_code=status.HTTP_404_NOT_FOUND, detail="AE 不存在")
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def _is_overdue(ae: AERead) -> bool:
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return bool(ae.report_due_date and date.today() > ae.report_due_date and ae.status != "CLOSED")
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def _ae_audit_name(ae) -> str:
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return str(getattr(ae, "term", "") or "").strip() or "AE 记录"
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def _ae_audit_detail(action: str, ae) -> str:
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name = _ae_audit_name(ae)
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return json.dumps({"targetName": name, "description": f"{action}AE“{name}”"}, ensure_ascii=False)
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@router.post(
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"/",
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response_model=AERead,
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status_code=status.HTTP_201_CREATED,
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dependencies=[Depends(require_api_permission("subject_aes:create")), Depends(require_study_not_locked())],
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)
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async def create_ae(
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study_id: uuid.UUID,
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ae_in: AECreate,
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db: AsyncSession = Depends(get_db_session),
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current_user=Depends(get_current_user),
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) -> AERead:
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await _ensure_study_exists(db, study_id)
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cra_scope = await get_cra_site_scope(db, study_id, current_user)
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if cra_scope:
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if ae_in.site_id and ae_in.site_id not in cra_scope[0]:
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raise HTTPException(status_code=status.HTTP_403_FORBIDDEN, detail="权限不足")
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if ae_in.subject_id:
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subj = await subject_crud.get_subject(db, ae_in.subject_id)
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if subj and subj.site_id not in cra_scope[0]:
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raise HTTPException(status_code=status.HTTP_403_FORBIDDEN, detail="权限不足")
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if ae_in.onset_date and ae_in.onset_date > date.today():
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raise HTTPException(status_code=status.HTTP_400_BAD_REQUEST, detail="发生日期不能晚于今天")
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try:
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ae = await ae_crud.create_ae(db, study_id, ae_in, created_by=current_user.id)
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except ValueError as exc:
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raise HTTPException(status_code=status.HTTP_400_BAD_REQUEST, detail=str(exc)) from exc
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await audit_crud.log_action(
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db,
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study_id=study_id,
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entity_type="ae",
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entity_id=ae.id,
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action="CREATE_AE",
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detail=_ae_audit_detail("创建", ae),
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operator_id=current_user.id,
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operator_role=await get_operator_role_label(db, study_id, current_user),
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)
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data = AERead.model_validate(ae)
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data.is_overdue = _is_overdue(data)
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return data
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async def _list_ae_records(
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study_id: uuid.UUID,
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status_filter: str | None,
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seriousness: str | None,
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site_id: uuid.UUID | None,
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subject_id: uuid.UUID | None,
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overdue: bool | None,
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db: AsyncSession,
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current_user,
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) -> list[AERead]:
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await _ensure_study_exists(db, study_id)
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cra_scope = await get_cra_site_scope(db, study_id, current_user)
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site_ids = cra_scope[0] if cra_scope else None
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if site_id and site_ids is not None and site_id not in site_ids:
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return []
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aes = await ae_crud.list_ae(
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db,
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study_id,
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status=status_filter,
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seriousness=seriousness,
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site_id=site_id,
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subject_id=subject_id,
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overdue=overdue,
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site_ids=site_ids,
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)
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result: list[AERead] = []
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for item in aes:
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obj = AERead.model_validate(item)
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obj.is_overdue = _is_overdue(obj)
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result.append(obj)
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return result
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@router.get(
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"/summary",
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response_model=list[AERead],
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dependencies=[Depends(require_api_permission("subject_aes:read"))],
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)
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async def list_risk_issue_ae(
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study_id: uuid.UUID,
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status_filter: str | None = None,
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seriousness: str | None = None,
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site_id: uuid.UUID | None = None,
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subject_id: uuid.UUID | None = None,
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overdue: bool | None = None,
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db: AsyncSession = Depends(get_db_session),
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current_user=Depends(get_current_user),
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) -> list[AERead]:
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return await _list_ae_records(
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study_id,
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status_filter,
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seriousness,
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site_id,
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subject_id,
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overdue,
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db,
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current_user,
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)
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@router.get(
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"/",
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response_model=list[AERead],
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dependencies=[Depends(require_api_permission("subject_aes:read"))],
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)
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async def list_ae(
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study_id: uuid.UUID,
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status_filter: str | None = None,
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seriousness: str | None = None,
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site_id: uuid.UUID | None = None,
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subject_id: uuid.UUID | None = None,
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overdue: bool | None = None,
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db: AsyncSession = Depends(get_db_session),
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current_user=Depends(get_current_user),
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) -> list[AERead]:
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return await _list_ae_records(
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study_id,
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status_filter,
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seriousness,
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site_id,
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subject_id,
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overdue,
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db,
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current_user,
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)
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@router.get(
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"/{ae_id}",
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response_model=AERead,
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dependencies=[Depends(require_api_permission("subject_aes:read"))],
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)
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async def get_ae(
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study_id: uuid.UUID,
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ae_id: uuid.UUID,
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db: AsyncSession = Depends(get_db_session),
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current_user=Depends(get_current_user),
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) -> AERead:
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await _ensure_study_exists(db, study_id)
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ae = await ae_crud.get_ae(db, ae_id)
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if not ae or ae.study_id != study_id:
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raise HTTPException(status_code=status.HTTP_404_NOT_FOUND, detail="AE 不存在")
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data = AERead.model_validate(ae)
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data.is_overdue = _is_overdue(data)
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cra_scope = await get_cra_site_scope(db, study_id, current_user)
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if cra_scope:
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if data.site_id and data.site_id not in cra_scope[0]:
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raise HTTPException(status_code=status.HTTP_403_FORBIDDEN, detail="权限不足")
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if data.subject_id:
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subj = await subject_crud.get_subject(db, data.subject_id)
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if subj and subj.site_id not in cra_scope[0]:
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raise HTTPException(status_code=status.HTTP_403_FORBIDDEN, detail="权限不足")
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return data
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@router.patch(
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"/{ae_id}",
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response_model=AERead,
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dependencies=[Depends(require_api_permission("subject_aes:update")), Depends(require_study_not_locked())],
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)
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async def update_ae(
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study_id: uuid.UUID,
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ae_id: uuid.UUID,
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ae_in: AEUpdate,
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db: AsyncSession = Depends(get_db_session),
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current_user=Depends(get_current_user),
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) -> AERead:
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await _ensure_study_exists(db, study_id)
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if ae_in.onset_date and ae_in.onset_date > date.today():
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raise HTTPException(status_code=status.HTTP_400_BAD_REQUEST, detail="发生日期不能晚于今天")
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ae = await ae_crud.get_ae(db, ae_id)
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if not ae or ae.study_id != study_id:
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raise HTTPException(status_code=status.HTTP_404_NOT_FOUND, detail="AE 不存在")
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await _ensure_ae_visible(db, study_id, AERead.model_validate(ae))
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old_status = ae.status
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detail_before = {
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"event": ae.term,
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"onset_date": ae.onset_date,
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"seriousness": ae.seriousness,
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"status": ae.status,
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"description": ae.description,
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}
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updated = await ae_crud.update_ae(db, study_id, ae, ae_in)
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detail_after = {
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"event": updated.term,
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"onset_date": updated.onset_date,
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"seriousness": updated.seriousness,
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"status": updated.status,
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"description": updated.description,
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}
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action = "UPDATE_AE"
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if ae_in.status and ae_in.status != old_status:
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action = "AE_STATUS_CHANGE"
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await audit_crud.log_action(
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db,
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study_id=study_id,
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entity_type="ae",
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entity_id=ae_id,
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action=action,
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detail=json.dumps(
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{
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"targetName": _ae_audit_name(updated),
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"description": f"{'变更' if action == 'AE_STATUS_CHANGE' else '更新'}AE“{_ae_audit_name(updated)}”",
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"before": detail_before,
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"after": detail_after,
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},
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ensure_ascii=False,
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default=str,
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),
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operator_id=current_user.id,
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operator_role=await get_operator_role_label(db, study_id, current_user),
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)
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data = AERead.model_validate(updated)
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data.is_overdue = _is_overdue(data)
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return data
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@router.delete(
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"/{ae_id}",
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status_code=status.HTTP_204_NO_CONTENT,
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dependencies=[Depends(require_api_permission("subject_aes:delete")), Depends(require_study_not_locked())],
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)
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async def delete_ae(
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study_id: uuid.UUID,
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ae_id: uuid.UUID,
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db: AsyncSession = Depends(get_db_session),
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current_user=Depends(get_current_user),
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) -> None:
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await _ensure_study_exists(db, study_id)
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ae = await ae_crud.get_ae(db, ae_id)
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if not ae or ae.study_id != study_id:
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raise HTTPException(status_code=status.HTTP_404_NOT_FOUND, detail="AE 不存在")
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await _ensure_ae_visible(db, study_id, AERead.model_validate(ae))
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ae_detail = _ae_audit_detail("删除", ae)
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await ae_crud.delete_ae(db, ae)
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await audit_crud.log_action(
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db,
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study_id=study_id,
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entity_type="ae",
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entity_id=ae_id,
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action="DELETE_AE",
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detail=ae_detail,
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operator_id=current_user.id,
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operator_role=await get_operator_role_label(db, study_id, current_user),
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)
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