Step 7：AE + 风险/问题管理（PV）

2025-12-16 17:55:53 +08:00
parent c77b20f932
commit f19faf1a1a
63 changed files with 707 additions and 1 deletions
@@ -0,0 +1,113 @@
+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("Site not found in study")
+    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("Subject not found in study")
+
+
+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=None,
+        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, ae: AdverseEvent, ae_in: AEUpdate) -> AdverseEvent:
+    update_data = ae_in.model_dump(exclude_unset=True)
+    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
@@ -0,0 +1,99 @@
+import uuid
+from datetime import date, datetime, timezone
+from typing import Sequence
+
+from sqlalchemy import select, update as sa_update
+from sqlalchemy.ext.asyncio import AsyncSession
+
+from app.models.issue import Issue
+from app.models.site import Site
+from app.models.subject import Subject
+from app.schemas.issue import IssueCreate, IssueUpdate
+
+
+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("Site not found in study")
+    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("Subject not found in study")
+
+
+async def create_issue(
+    db: AsyncSession,
+    study_id: uuid.UUID,
+    issue_in: IssueCreate,
+    *,
+    created_by: uuid.UUID,
+) -> Issue:
+    await _validate_site_subject(db, study_id, issue_in.site_id, issue_in.subject_id)
+    issue = Issue(
+        study_id=study_id,
+        site_id=issue_in.site_id,
+        subject_id=issue_in.subject_id,
+        title=issue_in.title,
+        description=issue_in.description,
+        category=issue_in.category,
+        level=issue_in.level,
+        owner_id=issue_in.owner_id,
+        due_date=issue_in.due_date,
+        status="OPEN",
+        capa=None,
+        closed_at=None,
+        created_by=created_by,
+    )
+    db.add(issue)
+    await db.commit()
+    await db.refresh(issue)
+    return issue
+
+
+async def get_issue(db: AsyncSession, issue_id: uuid.UUID) -> Issue | None:
+    result = await db.execute(select(Issue).where(Issue.id == issue_id))
+    return result.scalar_one_or_none()
+
+
+async def list_issues(
+    db: AsyncSession,
+    study_id: uuid.UUID,
+    status: str | None = None,
+    level: str | None = None,
+    category: str | None = None,
+    overdue: bool | None = None,
+) -> Sequence[Issue]:
+    stmt = select(Issue).where(Issue.study_id == study_id)
+    if status:
+        stmt = stmt.where(Issue.status == status)
+    if level:
+        stmt = stmt.where(Issue.level == level)
+    if category:
+        stmt = stmt.where(Issue.category == category)
+    if overdue is True:
+        stmt = stmt.where(Issue.due_date < date.today(), Issue.status != "CLOSED")
+    if overdue is False:
+        stmt = stmt.where((Issue.due_date >= date.today()) | (Issue.due_date.is_(None)) | (Issue.status == "CLOSED"))
+    result = await db.execute(stmt)
+    return result.scalars().all()
+
+
+async def update_issue(db: AsyncSession, issue: Issue, issue_in: IssueUpdate) -> Issue:
+    update_data = issue_in.model_dump(exclude_unset=True)
+    if "status" in update_data:
+        if update_data["status"] == "CLOSED":
+            update_data["closed_at"] = datetime.now(timezone.utc)
+        else:
+            update_data["closed_at"] = None
+    if update_data:
+        await db.execute(
+            sa_update(Issue)
+            .where(Issue.id == issue.id)
+            .values(**update_data)
+        )
+        await db.commit()
+    await db.refresh(issue)
+    return issue