Step 7：AE + 风险/问题管理（PV）

backend/app/api/v1/aes.py

@@ -0,0 +1,164 @@
+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_current_user, get_db_session, require_study_member
+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 study as study_crud
+from app.schemas.ae import AECreate, AERead, AEUpdate
+
+router = APIRouter()
+
+ALLOWED_CREATE_ROLES = {"PM", "CRA", "PV"}
+ALLOWED_UPDATE_ROLES = {"PM", "PV"}
+
+
+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="Study not found")
+    return study
+
+
+async def _get_member_role(db: AsyncSession, study_id: uuid.UUID, user_id: uuid.UUID) -> str | None:
+    member = await member_crud.get_member(db, study_id, user_id)
+    return member.role_in_study if member else None
+
+
+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_study_member())],
+)
+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)
+    member_role = await _get_member_role(db, study_id, current_user.id)
+    if current_user.role != "ADMIN" and member_role not in ALLOWED_CREATE_ROLES:
+        raise HTTPException(status_code=status.HTTP_403_FORBIDDEN, detail="Insufficient permissions")
+    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} created",
+        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_study_member())],
+)
+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),
+) -> list[AERead]:
+    await _ensure_study_exists(db, study_id)
+    aes = await ae_crud.list_ae(db, study_id, status=status_filter, seriousness=seriousness, site_id=site_id, subject_id=subject_id, overdue=overdue)
+    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_study_member())],
+)
+async def get_ae(
+    study_id: uuid.UUID,
+    ae_id: uuid.UUID,
+    db: AsyncSession = Depends(get_db_session),
+) -> 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 not found")
+    data = AERead.model_validate(ae)
+    data.is_overdue = _is_overdue(data)
+    return data
+
+
+@router.patch(
+    "/{ae_id}",
+    response_model=AERead,
+    dependencies=[Depends(require_study_member())],
+)
+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)
+    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 not found")
+
+    member_role = await _get_member_role(db, study_id, current_user.id)
+    if current_user.role == "ADMIN":
+        pass
+    elif member_role in ALLOWED_UPDATE_ROLES:
+        pass
+    elif member_role == "CRA":
+        if ae.created_by != current_user.id:
+            raise HTTPException(status_code=status.HTTP_403_FORBIDDEN, detail="Only creator can update AE")
+        if ae_in.status == "CLOSED":
+            raise HTTPException(status_code=status.HTTP_403_FORBIDDEN, detail="CRA cannot close AE")
+    else:
+        raise HTTPException(status_code=status.HTTP_403_FORBIDDEN, detail="Insufficient permissions")
+
+    old_status = ae.status
+    updated = await ae_crud.update_ae(db, ae, ae_in)
+
+    detail = None
+    action = "UPDATE_AE"
+    if ae_in.status and ae_in.status != old_status:
+        detail = f"AE {ae_id} status {old_status} -> {ae_in.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=detail or "AE updated",
+        operator_id=current_user.id,
+        operator_role=current_user.role,
+    )
+    data = AERead.model_validate(updated)
+    data.is_overdue = _is_overdue(data)
+    return data

backend/app/api/v1/issues.py

@@ -0,0 +1,156 @@
+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_current_user, get_db_session, require_study_member
+from app.crud import audit as audit_crud
+from app.crud import issue as issue_crud
+from app.crud import member as member_crud
+from app.crud import study as study_crud
+from app.schemas.issue import IssueCreate, IssueRead, IssueUpdate
+
+router = APIRouter()
+
+ALLOWED_EDIT_ROLES = {"PM", "PV"}
+
+
+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="Study not found")
+    return study
+
+
+async def _get_member_role(db: AsyncSession, study_id: uuid.UUID, user_id: uuid.UUID) -> str | None:
+    member = await member_crud.get_member(db, study_id, user_id)
+    return member.role_in_study if member else None
+
+
+def _is_overdue(issue: IssueRead) -> bool:
+    return bool(issue.due_date and date.today() > issue.due_date and issue.status != "CLOSED")
+
+
+@router.post(
+    "/",
+    response_model=IssueRead,
+    status_code=status.HTTP_201_CREATED,
+    dependencies=[Depends(require_study_member())],
+)
+async def create_issue(
+    study_id: uuid.UUID,
+    issue_in: IssueCreate,
+    db: AsyncSession = Depends(get_db_session),
+    current_user=Depends(get_current_user),
+) -> IssueRead:
+    await _ensure_study_exists(db, study_id)
+    member_role = await _get_member_role(db, study_id, current_user.id)
+    if current_user.role != "ADMIN" and member_role not in ALLOWED_EDIT_ROLES:
+        raise HTTPException(status_code=status.HTTP_403_FORBIDDEN, detail="Insufficient permissions")
+    try:
+        issue = await issue_crud.create_issue(db, study_id, issue_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="issue",
+        entity_id=issue.id,
+        action="CREATE_ISSUE",
+        detail=f"Issue {issue.id} created",
+        operator_id=current_user.id,
+        operator_role=current_user.role,
+    )
+    data = IssueRead.model_validate(issue)
+    data.is_overdue = _is_overdue(data)
+    return data
+
+
+@router.get(
+    "/",
+    response_model=list[IssueRead],
+    dependencies=[Depends(require_study_member())],
+)
+async def list_issues(
+    study_id: uuid.UUID,
+    status_filter: str | None = None,
+    level: str | None = None,
+    category: str | None = None,
+    overdue: bool | None = None,
+    db: AsyncSession = Depends(get_db_session),
+) -> list[IssueRead]:
+    await _ensure_study_exists(db, study_id)
+    issues = await issue_crud.list_issues(db, study_id, status=status_filter, level=level, category=category, overdue=overdue)
+    result: list[IssueRead] = []
+    for item in issues:
+        obj = IssueRead.model_validate(item)
+        obj.is_overdue = _is_overdue(obj)
+        result.append(obj)
+    return result
+
+
+@router.get(
+    "/{issue_id}",
+    response_model=IssueRead,
+    dependencies=[Depends(require_study_member())],
+)
+async def get_issue(
+    study_id: uuid.UUID,
+    issue_id: uuid.UUID,
+    db: AsyncSession = Depends(get_db_session),
+) -> IssueRead:
+    await _ensure_study_exists(db, study_id)
+    issue = await issue_crud.get_issue(db, issue_id)
+    if not issue or issue.study_id != study_id:
+        raise HTTPException(status_code=status.HTTP_404_NOT_FOUND, detail="Issue not found")
+    data = IssueRead.model_validate(issue)
+    data.is_overdue = _is_overdue(data)
+    return data
+
+
+@router.patch(
+    "/{issue_id}",
+    response_model=IssueRead,
+    dependencies=[Depends(require_study_member())],
+)
+async def update_issue(
+    study_id: uuid.UUID,
+    issue_id: uuid.UUID,
+    issue_in: IssueUpdate,
+    db: AsyncSession = Depends(get_db_session),
+    current_user=Depends(get_current_user),
+) -> IssueRead:
+    await _ensure_study_exists(db, study_id)
+    issue = await issue_crud.get_issue(db, issue_id)
+    if not issue or issue.study_id != study_id:
+        raise HTTPException(status_code=status.HTTP_404_NOT_FOUND, detail="Issue not found")
+
+    member_role = await _get_member_role(db, study_id, current_user.id)
+    if current_user.role != "ADMIN" and member_role not in ALLOWED_EDIT_ROLES:
+        raise HTTPException(status_code=status.HTTP_403_FORBIDDEN, detail="Insufficient permissions")
+
+    old_status = issue.status
+    old_level = issue.level
+    updated = await issue_crud.update_issue(db, issue, issue_in)
+
+    detail = None
+    action = "UPDATE_ISSUE"
+    if issue_in.status and issue_in.status != old_status:
+        detail = f"Issue {issue_id} status {old_status} -> {issue_in.status}"
+        action = "ISSUE_STATUS_CHANGE"
+    elif issue_in.level and issue_in.level != old_level:
+        detail = f"Issue {issue_id} level {old_level} -> {issue_in.level}"
+    await audit_crud.log_action(
+        db,
+        study_id=study_id,
+        entity_type="issue",
+        entity_id=issue_id,
+        action=action,
+        detail=detail or "Issue updated",
+        operator_id=current_user.id,
+        operator_role=current_user.role,
+    )
+    data = IssueRead.model_validate(updated)
+    data.is_overdue = _is_overdue(data)
+    return data

backend/app/api/v1/router.py

@@ -1,6 +1,6 @@
 from fastapi import APIRouter
 
-from app.api.v1 import auth, users, studies, sites, members, comments, attachments, audit_logs, milestones, tasks, dashboard, subjects, visits
+from app.api.v1 import auth, users, studies, sites, members, comments, attachments, audit_logs, milestones, tasks, dashboard, subjects, visits, aes, issues
 
 api_router = APIRouter()
 api_router.include_router(auth.router, prefix="/auth", tags=["auth"])
@@ -16,3 +16,5 @@ api_router.include_router(tasks.router, prefix="/studies/{study_id}/tasks", tags
 api_router.include_router(dashboard.router, prefix="/studies/{study_id}/dashboard", tags=["dashboard"])
 api_router.include_router(subjects.router, prefix="/studies/{study_id}/subjects", tags=["subjects"])
 api_router.include_router(visits.router, prefix="/studies/{study_id}/subjects/{subject_id}/visits", tags=["visits"])
+api_router.include_router(aes.router, prefix="/studies/{study_id}/aes", tags=["aes"])
+api_router.include_router(issues.router, prefix="/studies/{study_id}/issues", tags=["issues"])

backend/app/crud/ae.py

@@ -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

backend/app/crud/issue.py

@@ -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

backend/app/db/base.py

@@ -12,3 +12,5 @@ from app.models.milestone import Milestone  # noqa: F401
 from app.models.task import Task  # noqa: F401
 from app.models.subject import Subject  # noqa: F401
 from app.models.visit import Visit  # noqa: F401
+from app.models.ae import AdverseEvent  # noqa: F401
+from app.models.issue import Issue  # noqa: F401

backend/app/models/ae.py

@@ -0,0 +1,35 @@
+import uuid
+from datetime import datetime, date
+
+from sqlalchemy import Boolean, Date, DateTime, ForeignKey, String, Text, func
+from sqlalchemy.dialects.postgresql import UUID
+from sqlalchemy.orm import Mapped, mapped_column
+
+from app.db.base_class import Base
+
+
+class AdverseEvent(Base):
+    __tablename__ = "adverse_events"
+
+    id: Mapped[uuid.UUID] = mapped_column(UUID(as_uuid=True), primary_key=True, default=uuid.uuid4)
+    study_id: Mapped[uuid.UUID] = mapped_column(UUID(as_uuid=True), ForeignKey("studies.id"), index=True, nullable=False)
+    site_id: Mapped[uuid.UUID | None] = mapped_column(UUID(as_uuid=True), ForeignKey("sites.id"), index=True, nullable=True)
+    subject_id: Mapped[uuid.UUID | None] = mapped_column(UUID(as_uuid=True), ForeignKey("subjects.id"), index=True, nullable=True)
+    visit_id: Mapped[uuid.UUID | None] = mapped_column(UUID(as_uuid=True), nullable=True)
+    term: Mapped[str] = mapped_column(String(255), nullable=False)
+    onset_date: Mapped[date | None] = mapped_column(Date, nullable=True)
+    resolution_date: Mapped[date | None] = mapped_column(Date, nullable=True)
+    seriousness: Mapped[str] = mapped_column(String(50), nullable=False)
+    severity: Mapped[str] = mapped_column(String(50), nullable=False)
+    causality: Mapped[str | None] = mapped_column(String(50), nullable=True)
+    action_taken: Mapped[str | None] = mapped_column(Text, nullable=True)
+    outcome: Mapped[str | None] = mapped_column(String(50), nullable=True)
+    reported_to_sponsor: Mapped[bool] = mapped_column(Boolean, nullable=False, default=False)
+    report_due_date: Mapped[date | None] = mapped_column(Date, nullable=True)
+    status: Mapped[str] = mapped_column(String(20), nullable=False, default="NEW")
+    description: Mapped[str | None] = mapped_column(Text, nullable=True)
+    created_by: Mapped[uuid.UUID] = mapped_column(UUID(as_uuid=True), ForeignKey("users.id"), nullable=False)
+    created_at: Mapped[datetime] = mapped_column(DateTime(timezone=True), nullable=False, server_default=func.now())
+    updated_at: Mapped[datetime] = mapped_column(
+        DateTime(timezone=True), nullable=False, server_default=func.now(), onupdate=func.now()
+    )

backend/app/models/issue.py

@@ -0,0 +1,31 @@
+import uuid
+from datetime import datetime, date
+
+from sqlalchemy import Date, DateTime, ForeignKey, String, Text, func
+from sqlalchemy.dialects.postgresql import UUID
+from sqlalchemy.orm import Mapped, mapped_column
+
+from app.db.base_class import Base
+
+
+class Issue(Base):
+    __tablename__ = "issues"
+
+    id: Mapped[uuid.UUID] = mapped_column(UUID(as_uuid=True), primary_key=True, default=uuid.uuid4)
+    study_id: Mapped[uuid.UUID] = mapped_column(UUID(as_uuid=True), ForeignKey("studies.id"), index=True, nullable=False)
+    site_id: Mapped[uuid.UUID | None] = mapped_column(UUID(as_uuid=True), ForeignKey("sites.id"), index=True, nullable=True)
+    subject_id: Mapped[uuid.UUID | None] = mapped_column(UUID(as_uuid=True), ForeignKey("subjects.id"), index=True, nullable=True)
+    title: Mapped[str] = mapped_column(String(255), nullable=False)
+    description: Mapped[str | None] = mapped_column(Text, nullable=True)
+    category: Mapped[str] = mapped_column(String(50), nullable=False)
+    level: Mapped[str] = mapped_column(String(20), nullable=False)
+    owner_id: Mapped[uuid.UUID | None] = mapped_column(UUID(as_uuid=True), ForeignKey("users.id"), nullable=True)
+    due_date: Mapped[date | None] = mapped_column(Date, nullable=True)
+    status: Mapped[str] = mapped_column(String(20), nullable=False, default="OPEN")
+    capa: Mapped[str | None] = mapped_column(Text, nullable=True)
+    closed_at: Mapped[datetime | None] = mapped_column(DateTime(timezone=True), nullable=True)
+    created_by: Mapped[uuid.UUID] = mapped_column(UUID(as_uuid=True), ForeignKey("users.id"), nullable=False)
+    created_at: Mapped[datetime] = mapped_column(DateTime(timezone=True), nullable=False, server_default=func.now())
+    updated_at: Mapped[datetime] = mapped_column(
+        DateTime(timezone=True), nullable=False, server_default=func.now(), onupdate=func.now()
+    )

backend/app/schemas/ae.py

@@ -0,0 +1,55 @@
+import uuid
+from datetime import date, datetime
+from typing import Optional
+
+from pydantic import BaseModel, ConfigDict
+
+
+class AECreate(BaseModel):
+    site_id: Optional[uuid.UUID] = None
+    subject_id: Optional[uuid.UUID] = None
+    visit_id: Optional[uuid.UUID] = None
+    term: str
+    onset_date: Optional[date] = None
+    seriousness: str
+    severity: str
+    causality: Optional[str] = None
+    description: Optional[str] = None
+
+
+class AEUpdate(BaseModel):
+    resolution_date: Optional[date] = None
+    seriousness: Optional[str] = None
+    severity: Optional[str] = None
+    causality: Optional[str] = None
+    action_taken: Optional[str] = None
+    outcome: Optional[str] = None
+    reported_to_sponsor: Optional[bool] = None
+    status: Optional[str] = None
+    description: Optional[str] = None
+
+
+class AERead(BaseModel):
+    id: uuid.UUID
+    study_id: uuid.UUID
+    site_id: Optional[uuid.UUID]
+    subject_id: Optional[uuid.UUID]
+    visit_id: Optional[uuid.UUID]
+    term: str
+    onset_date: Optional[date]
+    resolution_date: Optional[date]
+    seriousness: str
+    severity: str
+    causality: Optional[str]
+    action_taken: Optional[str]
+    outcome: Optional[str]
+    reported_to_sponsor: bool
+    report_due_date: Optional[date]
+    status: str
+    description: Optional[str]
+    created_by: uuid.UUID
+    created_at: datetime
+    updated_at: datetime
+    is_overdue: bool | None = None
+
+    model_config = ConfigDict(from_attributes=True)

backend/app/schemas/issue.py

@@ -0,0 +1,49 @@
+import uuid
+from datetime import date, datetime
+from typing import Optional
+
+from pydantic import BaseModel, ConfigDict
+
+
+class IssueCreate(BaseModel):
+    title: str
+    category: str
+    level: str
+    due_date: Optional[date] = None
+    owner_id: Optional[uuid.UUID] = None
+    site_id: Optional[uuid.UUID] = None
+    subject_id: Optional[uuid.UUID] = None
+    description: Optional[str] = None
+
+
+class IssueUpdate(BaseModel):
+    title: Optional[str] = None
+    category: Optional[str] = None
+    level: Optional[str] = None
+    due_date: Optional[date] = None
+    owner_id: Optional[uuid.UUID] = None
+    status: Optional[str] = None
+    capa: Optional[str] = None
+    description: Optional[str] = None
+
+
+class IssueRead(BaseModel):
+    id: uuid.UUID
+    study_id: uuid.UUID
+    site_id: Optional[uuid.UUID]
+    subject_id: Optional[uuid.UUID]
+    title: str
+    description: Optional[str]
+    category: str
+    level: str
+    owner_id: Optional[uuid.UUID]
+    due_date: Optional[date]
+    status: str
+    capa: Optional[str]
+    closed_at: Optional[datetime]
+    created_by: uuid.UUID
+    created_at: datetime
+    updated_at: datetime
+    is_overdue: bool | None = None
+
+    model_config = ConfigDict(from_attributes=True)