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

import uuid

from fastapi import APIRouter, Depends, HTTPException, status
from sqlalchemy import select
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 audit as audit_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.models.ae import AdverseEvent
from app.schemas.subject import SubjectCreate, SubjectRead, SubjectUpdate

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_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")


@router.post(
    "/",
    response_model=SubjectRead,
    status_code=status.HTTP_201_CREATED,
    dependencies=[Depends(require_api_permission("POST:/subjects")), Depends(require_study_not_locked())],
)
async def create_subject(
    study_id: uuid.UUID,
    subject_in: SubjectCreate,
    db: AsyncSession = Depends(get_db_session),
    current_user=Depends(get_current_user),
) -> SubjectRead:
    await _ensure_study_exists(db, study_id)
    cra_scope = await get_cra_site_scope(db, study_id, current_user)
    if cra_scope and subject_in.site_id not in cra_scope[0]:
        raise HTTPException(status_code=status.HTTP_403_FORBIDDEN, detail="权限不足")
    try:
        subject = await subject_crud.create_subject(db, study_id, subject_in)
    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="subject",
        entity_id=subject.id,
        action="CREATE_SUBJECT",
        detail=f"参与者 {subject.subject_no} 已创建",
        operator_id=current_user.id,
        operator_role=current_user.role,
    )
    return subject


@router.get(
    "/",
    response_model=list[SubjectRead],
    dependencies=[Depends(require_api_permission("GET:/subjects"))],
)
async def list_subjects(
    study_id: uuid.UUID,
    site_id: uuid.UUID | None = None,
    db: AsyncSession = Depends(get_db_session),
    current_user=Depends(get_current_user),
) -> list[SubjectRead]:
    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 []
    subjects = await subject_crud.list_subjects(db, study_id, site_id=site_id, site_ids=site_ids)
    subject_list = list(subjects)
    if not subject_list:
        return []
    subject_ids = [subject.id for subject in subject_list]
    ae_rows = await db.execute(
        select(AdverseEvent.subject_id, AdverseEvent.is_sae, AdverseEvent.is_susar).where(
            AdverseEvent.study_id == study_id,
            AdverseEvent.subject_id.in_(subject_ids),
        )
    )
    ae_flags: dict[uuid.UUID, dict[str, bool]] = {}
    for row in ae_rows.all():
        sid = row[0]
        if not sid:
            continue
        if sid not in ae_flags:
            ae_flags[sid] = {"has_ae": True, "has_sae": False, "has_susar": False}
        if row[1]:
            ae_flags[sid]["has_sae"] = True
        if row[2]:
            ae_flags[sid]["has_susar"] = True
    result: list[SubjectRead] = []
    for subject in subject_list:
        data = SubjectRead.model_validate(subject)
        flags = ae_flags.get(subject.id, {"has_ae": False, "has_sae": False, "has_susar": False})
        data.has_ae = flags["has_ae"]
        data.has_sae = flags["has_sae"]
        data.has_susar = flags["has_susar"]
        result.append(data)
    return result


@router.get(
    "/{subject_id}",
    response_model=SubjectRead,
    dependencies=[Depends(require_api_permission("GET:/subjects/{id}"))],
)
async def get_subject(
    study_id: uuid.UUID,
    subject_id: uuid.UUID,
    db: AsyncSession = Depends(get_db_session),
    current_user=Depends(get_current_user),
) -> SubjectRead:
    await _ensure_study_exists(db, study_id)
    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")
    cra_scope = await get_cra_site_scope(db, study_id, current_user)
    if cra_scope and subject.site_id not in cra_scope[0]:
        raise HTTPException(status_code=status.HTTP_403_FORBIDDEN, detail="权限不足")
    await _ensure_subject_active(db, subject)
    data = SubjectRead.model_validate(subject)
    ae_row = await db.execute(
        select(AdverseEvent.is_sae, AdverseEvent.is_susar).where(
            AdverseEvent.study_id == study_id,
            AdverseEvent.subject_id == subject.id,
        )
    )
    ae_flags = {"has_ae": False, "has_sae": False, "has_susar": False}
    for row in ae_row.all():
        ae_flags["has_ae"] = True
        if row[0]:
            ae_flags["has_sae"] = True
        if row[1]:
            ae_flags["has_susar"] = True
    data.has_ae = ae_flags["has_ae"]
    data.has_sae = ae_flags["has_sae"]
    data.has_susar = ae_flags["has_susar"]
    return data


@router.patch(
    "/{subject_id}",
    response_model=SubjectRead,
    dependencies=[Depends(require_api_permission("PATCH:/subjects/{id}")), Depends(require_study_not_locked())],
)
async def update_subject(
    study_id: uuid.UUID,
    subject_id: uuid.UUID,
    subject_in: SubjectUpdate,
    db: AsyncSession = Depends(get_db_session),
    current_user=Depends(get_current_user),
) -> SubjectRead:
    await _ensure_study_exists(db, study_id)
    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")
    cra_scope = await get_cra_site_scope(db, study_id, current_user)
    if cra_scope and subject.site_id not in cra_scope[0]:
        raise HTTPException(status_code=status.HTTP_403_FORBIDDEN, detail="权限不足")
    await _ensure_subject_active(db, subject)
    old_status = subject.status
    updated = await subject_crud.update_subject(db, subject, subject_in)
    # 基线/治疗日期是访视计划的唯一推算基准，不能用入组日期替代。
    if updated.baseline_date:
        await subject_crud.sync_visits_from_baseline(db, updated)
    detail = None
    if subject_in.status and subject_in.status != old_status:
        detail = f"参与者 {updated.subject_no} 状态 {old_status} -> {subject_in.status}"
    await audit_crud.log_action(
        db,
        study_id=study_id,
        entity_type="subject",
        entity_id=subject_id,
        action="SUBJECT_STATUS_CHANGE" if detail else "UPDATE_SUBJECT",
        detail=detail or "参与者已更新",
        operator_id=current_user.id,
        operator_role=current_user.role,
    )
    return updated


@router.delete(
    "/{subject_id}",
    status_code=status.HTTP_204_NO_CONTENT,
    dependencies=[Depends(require_api_permission("DELETE:/subjects/{id}")), Depends(require_study_not_locked())],
)
async def delete_subject(
    study_id: uuid.UUID,
    subject_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 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")
    cra_scope = await get_cra_site_scope(db, study_id, current_user)
    if cra_scope and subject.site_id not in cra_scope[0]:
        raise HTTPException(status_code=status.HTTP_403_FORBIDDEN, detail="权限不足")
    await subject_crud.delete_subject(db, subject)
    await audit_crud.log_action(
        db,
        study_id=study_id,
        entity_type="subject",
        entity_id=subject_id,
        action="DELETE_SUBJECT",
        detail=f"参与者 {subject_id} 已删除",
        operator_id=current_user.id,
        operator_role=current_user.role,
    )