Cheng Zhou
276 lines
10 KiB
Python
276 lines
10 KiB
Python
import json
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import uuid
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from fastapi import APIRouter, Depends, HTTPException, status
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from sqlalchemy import select
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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 audit as audit_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.models.ae import AdverseEvent
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from app.schemas.subject import SubjectCreate, SubjectRead, SubjectUpdate
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router = APIRouter()
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def _format_date(value):
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return value.isoformat() if value else None
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async def _subject_audit_snapshot(db: AsyncSession, subject) -> dict:
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site_name = None
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if subject.site_id:
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site = await site_crud.get_site(db, subject.site_id)
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site_name = site.name if site else None
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return {
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"subject_no": subject.subject_no,
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"site_name": site_name,
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"status": subject.status,
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"screening_date": _format_date(subject.screening_date),
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"consent_date": _format_date(subject.consent_date),
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"enrollment_date": _format_date(subject.enrollment_date),
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"baseline_date": _format_date(subject.baseline_date),
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"completion_date": _format_date(subject.completion_date),
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"actual_medication_count": subject.actual_medication_count,
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"drop_reason": subject.drop_reason,
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}
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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_subject_active(db: AsyncSession, subject) -> None:
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if not subject or not subject.site_id:
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return
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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_403_FORBIDDEN, detail="中心已停用")
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@router.post(
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"/",
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response_model=SubjectRead,
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status_code=status.HTTP_201_CREATED,
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dependencies=[Depends(require_api_permission("subjects:create")), Depends(require_study_not_locked())],
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)
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async def create_subject(
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study_id: uuid.UUID,
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subject_in: SubjectCreate,
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db: AsyncSession = Depends(get_db_session),
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current_user=Depends(get_current_user),
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) -> SubjectRead:
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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 and subject_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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try:
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subject = await subject_crud.create_subject(db, study_id, subject_in)
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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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after_snapshot = await _subject_audit_snapshot(db, subject)
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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="subject",
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entity_id=subject.id,
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action="CREATE_SUBJECT",
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detail=json.dumps(
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{
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"targetName": subject.subject_no,
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"description": f"创建参与者 {subject.subject_no}",
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"before": None,
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"after": after_snapshot,
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},
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ensure_ascii=False,
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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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return subject
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@router.get(
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"/",
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response_model=list[SubjectRead],
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dependencies=[Depends(require_api_permission("subjects:read"))],
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)
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async def list_subjects(
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study_id: uuid.UUID,
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site_id: uuid.UUID | 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[SubjectRead]:
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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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subjects = await subject_crud.list_subjects(db, study_id, site_id=site_id, site_ids=site_ids)
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subject_list = list(subjects)
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if not subject_list:
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return []
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subject_ids = [subject.id for subject in subject_list]
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ae_rows = await db.execute(
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select(AdverseEvent.subject_id, AdverseEvent.is_sae, AdverseEvent.is_susar).where(
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AdverseEvent.study_id == study_id,
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AdverseEvent.subject_id.in_(subject_ids),
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)
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)
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ae_flags: dict[uuid.UUID, dict[str, bool]] = {}
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for row in ae_rows.all():
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sid = row[0]
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if not sid:
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continue
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if sid not in ae_flags:
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ae_flags[sid] = {"has_ae": True, "has_sae": False, "has_susar": False}
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if row[1]:
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ae_flags[sid]["has_sae"] = True
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if row[2]:
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ae_flags[sid]["has_susar"] = True
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result: list[SubjectRead] = []
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for subject in subject_list:
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data = SubjectRead.model_validate(subject)
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flags = ae_flags.get(subject.id, {"has_ae": False, "has_sae": False, "has_susar": False})
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data.has_ae = flags["has_ae"]
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data.has_sae = flags["has_sae"]
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data.has_susar = flags["has_susar"]
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result.append(data)
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return result
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@router.get(
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"/{subject_id}",
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response_model=SubjectRead,
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dependencies=[Depends(require_api_permission("subjects:read"))],
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)
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async def get_subject(
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study_id: uuid.UUID,
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subject_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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) -> SubjectRead:
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await _ensure_study_exists(db, study_id)
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subject = await subject_crud.get_subject(db, 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="参与者不存在")
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cra_scope = await get_cra_site_scope(db, study_id, current_user)
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if cra_scope and subject.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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await _ensure_subject_active(db, subject)
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data = SubjectRead.model_validate(subject)
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ae_row = await db.execute(
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select(AdverseEvent.is_sae, AdverseEvent.is_susar).where(
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AdverseEvent.study_id == study_id,
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AdverseEvent.subject_id == subject.id,
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)
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)
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ae_flags = {"has_ae": False, "has_sae": False, "has_susar": False}
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for row in ae_row.all():
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ae_flags["has_ae"] = True
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if row[0]:
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ae_flags["has_sae"] = True
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if row[1]:
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ae_flags["has_susar"] = True
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data.has_ae = ae_flags["has_ae"]
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data.has_sae = ae_flags["has_sae"]
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data.has_susar = ae_flags["has_susar"]
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return data
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@router.patch(
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"/{subject_id}",
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response_model=SubjectRead,
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dependencies=[Depends(require_api_permission("subjects:update")), Depends(require_study_not_locked())],
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)
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async def update_subject(
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study_id: uuid.UUID,
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subject_id: uuid.UUID,
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subject_in: SubjectUpdate,
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db: AsyncSession = Depends(get_db_session),
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current_user=Depends(get_current_user),
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) -> SubjectRead:
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await _ensure_study_exists(db, study_id)
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subject = await subject_crud.get_subject(db, 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="参与者不存在")
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cra_scope = await get_cra_site_scope(db, study_id, current_user)
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if cra_scope and subject.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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await _ensure_subject_active(db, subject)
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old_status = subject.status
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before_snapshot = await _subject_audit_snapshot(db, subject)
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updated = await subject_crud.update_subject(db, subject, subject_in)
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# 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。
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if updated.baseline_date:
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await subject_crud.sync_visits_from_baseline(db, updated)
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updated = await subject_crud.sync_subject_status(db, updated)
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after_snapshot = await _subject_audit_snapshot(db, updated)
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description = f"变更参与者 {updated.subject_no} 状态" if updated.status != old_status else f"更新参与者 {updated.subject_no}"
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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="subject",
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entity_id=subject_id,
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action="SUBJECT_STATUS_CHANGE" if updated.status != old_status else "UPDATE_SUBJECT",
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detail=json.dumps(
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{
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"targetName": updated.subject_no,
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"description": description,
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"before": before_snapshot,
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"after": after_snapshot,
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},
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ensure_ascii=False,
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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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return updated
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@router.delete(
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"/{subject_id}",
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status_code=status.HTTP_204_NO_CONTENT,
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dependencies=[Depends(require_api_permission("subjects:delete")), Depends(require_study_not_locked())],
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)
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async def delete_subject(
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study_id: uuid.UUID,
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subject_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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subject = await subject_crud.get_subject(db, 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="参与者不存在")
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cra_scope = await get_cra_site_scope(db, study_id, current_user)
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if cra_scope and subject.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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before_snapshot = await _subject_audit_snapshot(db, subject)
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target_name = subject.subject_no
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await subject_crud.delete_subject(db, subject)
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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="subject",
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entity_id=subject_id,
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action="DELETE_SUBJECT",
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detail=json.dumps(
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{
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"targetName": target_name,
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"description": f"删除参与者 {target_name}",
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"before": before_snapshot,
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"after": None,
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},
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ensure_ascii=False,
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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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