import uuid from datetime import date, timedelta from typing import Sequence from sqlalchemy import select, update as sa_update from sqlalchemy.ext.asyncio import AsyncSession from app.models.ae import AdverseEvent from app.models.site import Site from app.models.subject import Subject from app.schemas.ae import AECreate, AEUpdate def _calc_due_date(onset: date | None, seriousness: str) -> date | None: if onset is None: return None delta = 1 if seriousness == "SERIOUS" else 7 return onset + timedelta(days=delta) async def _validate_site_subject(db: AsyncSession, study_id: uuid.UUID, site_id: uuid.UUID | None, subject_id: uuid.UUID | None): if site_id: result = await db.execute(select(Site).where(Site.id == site_id)) site = result.scalar_one_or_none() if not site or site.study_id != study_id: raise ValueError("分中心不属于当前项目") if subject_id: result = await db.execute(select(Subject).where(Subject.id == subject_id)) subj = result.scalar_one_or_none() if not subj or subj.study_id != study_id: raise ValueError("受试者不属于当前项目") async def create_ae( db: AsyncSession, study_id: uuid.UUID, ae_in: AECreate, *, created_by: uuid.UUID, ) -> AdverseEvent: await _validate_site_subject(db, study_id, ae_in.site_id, ae_in.subject_id) due_date = _calc_due_date(ae_in.onset_date, ae_in.seriousness) ae = AdverseEvent( study_id=study_id, site_id=ae_in.site_id, subject_id=ae_in.subject_id, visit_id=ae_in.visit_id, term=ae_in.term, onset_date=ae_in.onset_date, resolution_date=None, seriousness=ae_in.seriousness, severity=ae_in.severity, causality=ae_in.causality, action_taken=None, outcome=ae_in.outcome, reported_to_sponsor=False, report_due_date=due_date, status="NEW", description=ae_in.description, created_by=created_by, ) db.add(ae) await db.commit() await db.refresh(ae) return ae async def get_ae(db: AsyncSession, ae_id: uuid.UUID) -> AdverseEvent | None: result = await db.execute(select(AdverseEvent).where(AdverseEvent.id == ae_id)) return result.scalar_one_or_none() async def list_ae( db: AsyncSession, study_id: uuid.UUID, status: str | None = None, seriousness: str | None = None, site_id: uuid.UUID | None = None, subject_id: uuid.UUID | None = None, overdue: bool | None = None, ) -> Sequence[AdverseEvent]: stmt = select(AdverseEvent).where(AdverseEvent.study_id == study_id) if status: stmt = stmt.where(AdverseEvent.status == status) if seriousness: stmt = stmt.where(AdverseEvent.seriousness == seriousness) if site_id: stmt = stmt.where(AdverseEvent.site_id == site_id) if subject_id: stmt = stmt.where(AdverseEvent.subject_id == subject_id) if overdue is True: stmt = stmt.where(AdverseEvent.report_due_date < date.today(), AdverseEvent.status != "CLOSED") if overdue is False: stmt = stmt.where((AdverseEvent.report_due_date >= date.today()) | (AdverseEvent.report_due_date.is_(None)) | (AdverseEvent.status == "CLOSED")) result = await db.execute(stmt) return result.scalars().all() async def update_ae(db: AsyncSession, study_id: uuid.UUID, ae: AdverseEvent, ae_in: AEUpdate) -> AdverseEvent: update_data = ae_in.model_dump(exclude_unset=True) if "subject_id" in update_data: await _validate_site_subject(db, study_id, None, update_data["subject_id"]) if "onset_date" in update_data or "seriousness" in update_data: onset = update_data.get("onset_date", ae.onset_date) seriousness = update_data.get("seriousness", ae.seriousness) update_data["report_due_date"] = _calc_due_date(onset, seriousness) if update_data: await db.execute( sa_update(AdverseEvent) .where(AdverseEvent.id == ae.id) .values(**update_data) ) await db.commit() await db.refresh(ae) return ae async def delete_ae(db: AsyncSession, ae: AdverseEvent) -> None: await db.delete(ae) await db.commit()