ctms/backend/app/api/v1/aes.py

import json
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_cra_site_scope, get_current_user, get_db_session, require_study_not_locked, require_api_permission
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 site as site_crud
from app.crud import subject as subject_crud
from app.crud import study as study_crud
from app.schemas.ae import AECreate, AERead, AEUpdate

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


async def _ensure_ae_visible(db: AsyncSession, study_id: uuid.UUID, ae: AERead | None):
    if not ae:
        raise HTTPException(status_code=status.HTTP_404_NOT_FOUND, detail="AE 不存在")
    if ae.site_id:
        site = await site_crud.get_site(db, ae.site_id)
        if not site or site.study_id != study_id or not site.is_active:
            raise HTTPException(status_code=status.HTTP_404_NOT_FOUND, detail="AE 不存在")
    if ae.subject_id:
        subject = await subject_crud.get_subject(db, ae.subject_id)
        if not subject or subject.study_id != study_id:
            raise HTTPException(status_code=status.HTTP_404_NOT_FOUND, detail="AE 不存在")
        site = await site_crud.get_site(db, subject.site_id)
        if not site or not site.is_active:
            raise HTTPException(status_code=status.HTTP_404_NOT_FOUND, detail="AE 不存在")


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_api_permission("POST:/risk-issues")), Depends(require_study_not_locked())],
)
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)
    cra_scope = await get_cra_site_scope(db, study_id, current_user)
    if cra_scope:
        if ae_in.site_id and ae_in.site_id not in cra_scope[0]:
            raise HTTPException(status_code=status.HTTP_403_FORBIDDEN, detail="权限不足")
        if ae_in.subject_id:
            subj = await subject_crud.get_subject(db, ae_in.subject_id)
            if subj and subj.site_id not in cra_scope[0]:
                raise HTTPException(status_code=status.HTTP_403_FORBIDDEN, detail="权限不足")
    if ae_in.onset_date and ae_in.onset_date > date.today():
        raise HTTPException(status_code=status.HTTP_400_BAD_REQUEST, detail="发生日期不能晚于今天")
    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} 已创建",
        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_api_permission("GET:/risk-issues"))],
)
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),
    current_user=Depends(get_current_user),
) -> list[AERead]:
    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
    if site_id and site_ids is not None and site_id not in site_ids:
        return []
    aes = await ae_crud.list_ae(
        db,
        study_id,
        status=status_filter,
        seriousness=seriousness,
        site_id=site_id,
        subject_id=subject_id,
        overdue=overdue,
        site_ids=site_ids,
    )
    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_api_permission("GET:/risk-issues/{id}"))],
)
async def get_ae(
    study_id: uuid.UUID,
    ae_id: uuid.UUID,
    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 不存在")
    data = AERead.model_validate(ae)
    data.is_overdue = _is_overdue(data)
    cra_scope = await get_cra_site_scope(db, study_id, current_user)
    if cra_scope:
        if data.site_id and data.site_id not in cra_scope[0]:
            raise HTTPException(status_code=status.HTTP_403_FORBIDDEN, detail="权限不足")
        if data.subject_id:
            subj = await subject_crud.get_subject(db, data.subject_id)
            if subj and subj.site_id not in cra_scope[0]:
                raise HTTPException(status_code=status.HTTP_403_FORBIDDEN, detail="权限不足")
    return data


@router.patch(
    "/{ae_id}",
    response_model=AERead,
    dependencies=[Depends(require_api_permission("PATCH:/risk-issues/{id}")), Depends(require_study_not_locked())],
)
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)
    if ae_in.onset_date and ae_in.onset_date > date.today():
        raise HTTPException(status_code=status.HTTP_400_BAD_REQUEST, detail="发生日期不能晚于今天")
    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 不存在")
    await _ensure_ae_visible(db, study_id, AERead.model_validate(ae))

    old_status = ae.status
    detail_before = {
        "event": ae.term,
        "onset_date": ae.onset_date,
        "seriousness": ae.seriousness,
        "status": ae.status,
        "description": ae.description,
    }
    updated = await ae_crud.update_ae(db, study_id, ae, ae_in)
    detail_after = {
        "event": updated.term,
        "onset_date": updated.onset_date,
        "seriousness": updated.seriousness,
        "status": updated.status,
        "description": updated.description,
    }

    action = "UPDATE_AE"
    if ae_in.status and ae_in.status != old_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=json.dumps({"before": detail_before, "after": detail_after}, ensure_ascii=False, default=str),
        operator_id=current_user.id,
        operator_role=current_user.role,
    )
    data = AERead.model_validate(updated)
    data.is_overdue = _is_overdue(data)
    return data


@router.delete(
    "/{ae_id}",
    status_code=status.HTTP_204_NO_CONTENT,
    dependencies=[Depends(require_api_permission("DELETE:/risk-issues/{id}")), Depends(require_study_not_locked())],
)
async def delete_ae(
    study_id: uuid.UUID,
    ae_id: uuid.UUID,
    db: AsyncSession = Depends(get_db_session),
    current_user=Depends(get_current_user),
) -> None:
    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 不存在")
    await _ensure_ae_visible(db, study_id, AERead.model_validate(ae))
    await ae_crud.delete_ae(db, ae)
    await audit_crud.log_action(
        db,
        study_id=study_id,
        entity_type="ae",
        entity_id=ae_id,
        action="DELETE_AE",
        detail=f"AE {ae_id} 已删除",
        operator_id=current_user.id,
        operator_role=current_user.role,
    )