立项配置页初步优化

2026-02-24 16:53:22 +08:00
parent 0693f09b1d
commit 8f3f717e48
124 changed files with 12519 additions and 2954 deletions
@@ -64,12 +64,14 @@ async def create_ae(
        term=ae_in.term,
        onset_date=ae_in.onset_date,
        resolution_date=None,
-        seriousness=str(ae_in.seriousness),
-        severity=str(ae_in.seriousness),
+        seriousness=ae_in.seriousness.value,
+        severity=ae_in.seriousness.value,
        causality=ae_in.causality,
        action_taken=None,
        outcome=ae_in.outcome,
        reported_to_sponsor=False,
+        is_sae=bool(ae_in.is_sae or ae_in.is_susar),
+        is_susar=bool(ae_in.is_susar),
        report_due_date=due_date,
        status="NEW",
        description=ae_in.description,
@@ -125,8 +127,14 @@ async def list_ae(

 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 "is_susar" in update_data and update_data["is_susar"]:
+        update_data["is_sae"] = True
+    if "is_sae" in update_data and update_data["is_sae"] is False:
+        update_data["is_susar"] = False
    if "seriousness" in update_data:
-        update_data["seriousness"] = str(update_data["seriousness"])
+        severity_value = update_data["seriousness"].value if hasattr(update_data["seriousness"], "value") else str(update_data["seriousness"])
+        update_data["seriousness"] = severity_value
+        update_data["severity"] = severity_value
    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:
@@ -17,6 +17,7 @@ async def log_action(
    detail: str | None,
    operator_id: uuid.UUID,
    operator_role: str,
+    auto_commit: bool = True,
 ) -> AuditLog:
    log = AuditLog(
        study_id=study_id,
@@ -28,8 +29,11 @@ async def log_action(
        operator_role=operator_role,
    )
    db.add(log)
-    await db.commit()
-    await db.refresh(log)
+    if auto_commit:
+        await db.commit()
+        await db.refresh(log)
+    else:
+        await db.flush()
    return log


@@ -25,6 +25,7 @@ from app.models.site import Site
 from app.models.special_expense import SpecialExpense
 from app.models.startup_ethics import StartupEthics
 from app.models.startup_feasibility import StartupFeasibility
+from app.models.study_center_confirm import StudyCenterConfirm
 from app.models.subject import Subject
 from app.models.subject_history import SubjectHistory
 from app.models.training_authorization import TrainingAuthorization
@@ -44,6 +45,9 @@ async def create_site(db: AsyncSession, study_id: uuid.UUID, site_in: SiteCreate
        pi_name=site_in.pi_name,
        contact=site_in.contact,
        is_active=site_in.is_active,
+        enrollment_plan_start_date=site_in.enrollment_plan_start_date,
+        enrollment_plan_end_date=site_in.enrollment_plan_end_date,
+        enrollment_plan_note=site_in.enrollment_plan_note,
    )
    db.add(site)
    await db.commit()
@@ -314,6 +318,7 @@ async def delete_site_and_related(db: AsyncSession, site: Site) -> None:
    await db.execute(delete(AdverseEvent).where(AdverseEvent.site_id == site_id))
    await db.execute(delete(FinanceItem).where(FinanceItem.site_id == site_id))
    await db.execute(delete(Subject).where(Subject.site_id == site_id))
+    await db.execute(delete(StudyCenterConfirm).where(StudyCenterConfirm.site_id == site_id))

    await db.execute(delete(Milestone).where(Milestone.site_id == site_id))
    await db.execute(delete(KickoffMeeting).where(KickoffMeeting.site_id == site_id))
@@ -9,23 +9,29 @@ from app.schemas.study import StudyCreate, StudyUpdate


 async def create(db: AsyncSession, study_in: StudyCreate, *, created_by: uuid.UUID | None = None) -> Study:
-    import uuid as uuid_lib  # Import uuid to generate unique code if needed
-
-    code = study_in.code
-    if not code:
-        # Generate a unique code if not provided
-        # Use first 8 chars of a new UUID, uppercase
-        code = f"P-{str(uuid_lib.uuid4())[:8].upper()}"
-
    study = Study(
-        code=code,
+        code=study_in.code.strip(),
        name=study_in.name,
-        # sponsor is removed from schema, but model has it. Set to None/empty or keep existing value if schema had it (which it doesn't now)
-        # If we removed it from schema, study_in.sponsor will fail if we try to access it via .sponsor attribute directly if it's not in the pydantic model anymore.
-        # Since we removed `sponsor` field from StudyCreate, `study_in` object won't have `sponsor` attribute unless we access dict or use default.
-        # However, the Study MODEL still has sponsor. We should set it to None.
-        sponsor=None,
+        project_full_name=study_in.project_full_name,
+        sponsor=study_in.sponsor,
        protocol_no=study_in.protocol_no,
+        lead_unit=study_in.lead_unit,
+        principal_investigator=study_in.principal_investigator,
+        main_pm=study_in.main_pm,
+        research_analysis=study_in.research_analysis,
+        research_product=study_in.research_product,
+        control_product=study_in.control_product,
+        indication=study_in.indication,
+        research_population=study_in.research_population,
+        research_design=study_in.research_design,
+        plan_start_date=study_in.plan_start_date,
+        plan_end_date=study_in.plan_end_date,
+        planned_site_count=study_in.planned_site_count,
+        planned_enrollment_count=study_in.planned_enrollment_count,
+        enrollment_monthly_goal_note=study_in.enrollment_monthly_goal_note,
+        enrollment_stage_breakdown=study_in.enrollment_stage_breakdown,
+        summary_note=study_in.summary_note,
+        objective_note=study_in.objective_note,
        phase=study_in.phase,
        status=study_in.status,
        visit_interval_days=study_in.visit_interval_days,
@@ -114,6 +120,10 @@ async def delete(db: AsyncSession, study_id: uuid.UUID) -> None:
    from app.models.faq_category import FaqCategory
    from app.models.faq_item import FaqItem
    from app.models.faq_reply import FaqReply
+    from app.models.study_setup_config import StudySetupConfig
+    from app.models.study_setup_config_version import StudySetupConfigVersion
+    from app.models.study_monitoring_strategy import StudyMonitoringStrategy
+    from app.models.study_center_confirm import StudyCenterConfirm
    
    # 按依赖关系顺序删除关联数据
    # 1. 删除审计日志
@@ -160,13 +170,21 @@ async def delete(db: AsyncSession, study_id: uuid.UUID) -> None:
    await db.execute(sa_delete(SubjectHistory).where(SubjectHistory.study_id == study_id))
    await db.execute(sa_delete(Subject).where(Subject.study_id == study_id))
    
-    # 13. 删除站点
+    # 13. 删除立项联动实体（需先于站点删除，避免外键约束）
+    await db.execute(sa_delete(StudyMonitoringStrategy).where(StudyMonitoringStrategy.study_id == study_id))
+    await db.execute(sa_delete(StudyCenterConfirm).where(StudyCenterConfirm.study_id == study_id))
+
+    # 14. 删除站点
    await db.execute(sa_delete(Site).where(Site.study_id == study_id))
-    
-    # 14. 删除成员
+
+    # 15. 删除成员
    await db.execute(sa_delete(StudyMember).where(StudyMember.study_id == study_id))
-    
-    # 15. 最后删除项目本身
+
+    # 16. 删除立项配置
+    await db.execute(sa_delete(StudySetupConfigVersion).where(StudySetupConfigVersion.study_id == study_id))
+    await db.execute(sa_delete(StudySetupConfig).where(StudySetupConfig.study_id == study_id))
+
+    # 17. 最后删除项目本身
    await db.execute(sa_delete(Study).where(Study.id == study_id))
    
    await db.commit()
@@ -0,0 +1,171 @@
+import uuid
+from datetime import datetime
+
+from sqlalchemy import delete as sa_delete, select
+from sqlalchemy import func
+from sqlalchemy.ext.asyncio import AsyncSession
+
+from app.models.study_setup_config import StudySetupConfig
+from app.models.study_setup_config_version import StudySetupConfigVersion
+from app.schemas.study_setup_config import StudySetupConfigData
+
+
+def _to_storage(data: StudySetupConfigData | dict) -> dict:
+    if isinstance(data, StudySetupConfigData):
+        return data.model_dump(mode="json")
+    return data
+
+
+async def get_by_study(db: AsyncSession, study_id: uuid.UUID) -> StudySetupConfig | None:
+    result = await db.execute(select(StudySetupConfig).where(StudySetupConfig.study_id == study_id))
+    return result.scalar_one_or_none()
+
+
+async def upsert(
+    db: AsyncSession,
+    study_id: uuid.UUID,
+    *,
+    expected_version: int | None,
+    data: StudySetupConfigData | dict,
+    saved_by: uuid.UUID | None,
+) -> tuple[StudySetupConfig | None, bool]:
+    existing = await get_by_study(db, study_id)
+    payload = _to_storage(data)
+    if existing:
+        if expected_version is not None and expected_version != existing.version:
+            return None, True
+        existing.version = existing.version + 1
+        existing.config = payload
+        existing.saved_by = saved_by
+        existing.publish_status = "PUBLISHED" if existing.published_config == payload else "DRAFT"
+        existing.updated_at = datetime.utcnow()
+        await db.commit()
+        await db.refresh(existing)
+        return existing, False
+
+    record = StudySetupConfig(
+        study_id=study_id,
+        version=1,
+        config=payload,
+        publish_status="DRAFT",
+        saved_by=saved_by,
+    )
+    db.add(record)
+    await db.commit()
+    await db.refresh(record)
+    return record, False
+
+
+async def publish(
+    db: AsyncSession,
+    study_id: uuid.UUID,
+    *,
+    expected_version: int | None,
+    published_by: uuid.UUID | None,
+    auto_commit: bool = True,
+) -> tuple[StudySetupConfig | None, bool]:
+    existing = await get_by_study(db, study_id)
+    if not existing:
+        return None, False
+    if expected_version is not None and expected_version != existing.version:
+        return None, True
+    next_version = existing.version + 1
+    next_display_version_stmt = select(func.max(StudySetupConfigVersion.display_version)).where(
+        StudySetupConfigVersion.study_id == study_id
+    )
+    display_version_result = await db.execute(next_display_version_stmt)
+    current_max_display_version = display_version_result.scalar_one_or_none() or 0
+    next_display_version = current_max_display_version + 1
+    existing.version = next_version
+    existing.publish_status = "PUBLISHED"
+    existing.published_config = existing.config
+    existing.published_by = published_by
+    existing.published_at = datetime.utcnow()
+    existing.saved_by = published_by
+    existing.updated_at = datetime.utcnow()
+    snapshot = StudySetupConfigVersion(
+        study_setup_config_id=existing.id,
+        study_id=study_id,
+        version=next_version,
+        display_version=next_display_version,
+        source_version=next_version - 1,
+        config=existing.config,
+        published_by=published_by,
+        published_at=existing.published_at,
+    )
+    db.add(snapshot)
+    if auto_commit:
+        await db.commit()
+        await db.refresh(existing)
+    else:
+        await db.flush()
+    return existing, False
+
+
+async def list_versions(db: AsyncSession, study_id: uuid.UUID) -> list[StudySetupConfigVersion]:
+    result = await db.execute(
+        select(StudySetupConfigVersion)
+        .where(StudySetupConfigVersion.study_id == study_id)
+        .order_by(StudySetupConfigVersion.version.desc(), StudySetupConfigVersion.published_at.desc())
+    )
+    return list(result.scalars().all())
+
+
+async def rollback_to_version(
+    db: AsyncSession,
+    study_id: uuid.UUID,
+    *,
+    expected_version: int | None,
+    target_version: int,
+    saved_by: uuid.UUID | None,
+) -> tuple[StudySetupConfig | None, bool, bool]:
+    existing = await get_by_study(db, study_id)
+    if not existing:
+        return None, False, False
+    if expected_version is not None and expected_version != existing.version:
+        return None, True, False
+
+    result = await db.execute(
+        select(StudySetupConfigVersion).where(
+            StudySetupConfigVersion.study_id == study_id,
+            StudySetupConfigVersion.version == target_version,
+        )
+    )
+    target = result.scalar_one_or_none()
+    if not target:
+        return None, False, True
+
+    existing.version = existing.version + 1
+    existing.config = target.config
+    existing.saved_by = saved_by
+    existing.publish_status = "DRAFT"
+    existing.updated_at = datetime.utcnow()
+    await db.commit()
+    await db.refresh(existing)
+    return existing, False, False
+
+
+async def delete_version(
+    db: AsyncSession,
+    study_id: uuid.UUID,
+    *,
+    target_version: int,
+) -> bool:
+    result = await db.execute(
+        select(StudySetupConfigVersion).where(
+            StudySetupConfigVersion.study_id == study_id,
+            StudySetupConfigVersion.version == target_version,
+        )
+    )
+    target = result.scalar_one_or_none()
+    if not target:
+        return False
+    await db.delete(target)
+    await db.commit()
+    return True
+
+
+async def delete_by_study(db: AsyncSession, study_id: uuid.UUID) -> None:
+    await db.execute(sa_delete(StudySetupConfigVersion).where(StudySetupConfigVersion.study_id == study_id))
+    await db.execute(sa_delete(StudySetupConfig).where(StudySetupConfig.study_id == study_id))
+    await db.commit()
@@ -16,6 +16,27 @@ from app.models.subject import Subject
 from app.schemas.subject import SubjectCreate, SubjectUpdate


+def _validate_subject_date_chain(
+    *,
+    screening_date: date | None,
+    consent_date: date | None,
+    enrollment_date: date | None,
+    completion_date: date | None,
+) -> None:
+    if screening_date and consent_date and consent_date < screening_date:
+        raise ValueError("知情同意日期不能早于筛选日期")
+    if screening_date and enrollment_date and enrollment_date < screening_date:
+        raise ValueError("入组日期不能早于筛选日期")
+    if consent_date and enrollment_date and enrollment_date < consent_date:
+        raise ValueError("入组日期不能早于知情同意日期")
+    if screening_date and completion_date and completion_date < screening_date:
+        raise ValueError("完成日期不能早于筛选日期")
+    if consent_date and completion_date and completion_date < consent_date:
+        raise ValueError("完成日期不能早于知情同意日期")
+    if enrollment_date and completion_date and completion_date < enrollment_date:
+        raise ValueError("完成日期不能早于入组日期")
+
+
 async def _validate_site(db: AsyncSession, study_id: uuid.UUID, site_id: uuid.UUID) -> None:
    result = await db.execute(select(Site).where(Site.id == site_id))
    site = result.scalar_one_or_none()
@@ -27,6 +48,12 @@ async def _validate_site(db: AsyncSession, study_id: uuid.UUID, site_id: uuid.UU

 async def create_subject(db: AsyncSession, study_id: uuid.UUID, subject_in: SubjectCreate) -> Subject:
    await _validate_site(db, study_id, subject_in.site_id)
+    _validate_subject_date_chain(
+        screening_date=subject_in.screening_date,
+        consent_date=subject_in.consent_date,
+        enrollment_date=None,
+        completion_date=None,
+    )
    subject = Subject(
        study_id=study_id,
        site_id=subject_in.site_id,
@@ -121,6 +148,16 @@ async def generate_default_visits(db: AsyncSession, subject: Subject) -> None:

 async def update_subject(db: AsyncSession, subject: Subject, subject_in: SubjectUpdate) -> Subject:
    update_data = subject_in.model_dump(exclude_unset=True)
+    next_screening_date = subject.screening_date
+    next_consent_date = update_data.get("consent_date", subject.consent_date)
+    next_enrollment_date = update_data.get("enrollment_date", subject.enrollment_date)
+    next_completion_date = update_data.get("completion_date", subject.completion_date)
+    _validate_subject_date_chain(
+        screening_date=next_screening_date,
+        consent_date=next_consent_date,
+        enrollment_date=next_enrollment_date,
+        completion_date=next_completion_date,
+    )
    if update_data:
        await db.execute(
            sa_update(Subject)