新增电子试验主文件目录与文件归档

backend/app/services/document_service.py

@@ -1,3 +1,5 @@
+from __future__ import annotations
+
 import hashlib
 import json
 import uuid
@@ -16,6 +18,7 @@ from app.core.project_permissions import role_has_api_permission
 from app.crud import acknowledgement as acknowledgement_crud
 from app.crud import distribution as distribution_crud
 from app.crud import document as document_crud
+from app.crud import etmf as etmf_crud
 from app.crud import document_version as version_crud
 from app.crud import member as member_crud
 from app.crud import site as site_crud
@@ -58,6 +61,7 @@ def _doc_snapshot(doc: Document) -> dict:
         "id": str(doc.id),
         "trial_id": str(doc.trial_id),
         "site_id": str(doc.site_id) if doc.site_id else None,
+        "etmf_node_id": str(doc.etmf_node_id) if doc.etmf_node_id else None,
         "doc_no": doc.doc_no,
         "status": str(doc.status),
         "current_effective_version_id": str(doc.current_effective_version_id) if doc.current_effective_version_id else None,
@@ -108,9 +112,20 @@ async def create_document(
     current_user,
 ) -> Document:
     await _ensure_study_access(db, doc_in.trial_id, current_user, action="create_document")
-    if doc_in.scope_type == DocumentScopeType.SITE and not doc_in.site_id:
+    etmf_node = None
+    if doc_in.etmf_node_id:
+        etmf_node = await etmf_crud.get_node(db, doc_in.etmf_node_id)
+        if not etmf_node:
+            raise HTTPException(status_code=status.HTTP_404_NOT_FOUND, detail="eTMF目录不存在")
+        if etmf_node.study_id != doc_in.trial_id:
+            raise HTTPException(status_code=status.HTTP_400_BAD_REQUEST, detail="eTMF目录不属于当前项目")
+        if etmf_node.scope_type == DocumentScopeType.SITE and not doc_in.site_id:
+            raise HTTPException(status_code=status.HTTP_422_UNPROCESSABLE_ENTITY, detail="中心级eTMF目录需指定中心")
+
+    scope_type = etmf_node.scope_type if etmf_node else doc_in.scope_type
+    if scope_type == DocumentScopeType.SITE and not doc_in.site_id:
         raise HTTPException(status_code=status.HTTP_422_UNPROCESSABLE_ENTITY, detail="分中心文件需指定分中心")
-    site_id = doc_in.site_id if doc_in.scope_type == DocumentScopeType.SITE else None
+    site_id = doc_in.site_id if scope_type == DocumentScopeType.SITE else None
     if site_id:
         site = await site_crud.get_site(db, site_id)
         if not site or not site.is_active:
@@ -122,10 +137,11 @@ async def create_document(
     doc = Document(
         trial_id=doc_in.trial_id,
         site_id=site_id,
+        etmf_node_id=doc_in.etmf_node_id,
         doc_no=doc_in.doc_no,
         doc_type=doc_in.doc_type,
         title=doc_in.title,
-        scope_type=doc_in.scope_type,
+        scope_type=scope_type,
         owner_id=doc_in.owner_id,
         description=doc_in.description,
     )
@@ -154,6 +170,7 @@ async def list_documents(
     doc_type: str | None,
     status: str | None,
     scope_type: str | None,
+    etmf_node_id: uuid.UUID | None = None,
     skip: int,
     limit: int,
     current_user,
@@ -168,6 +185,7 @@ async def list_documents(
         doc_type=doc_type,
         status=status,
         scope_type=scope_type,
+        etmf_node_id=etmf_node_id,
         cra_site_ids=cra_site_ids,
         skip=skip,
         limit=limit,
@@ -185,6 +203,7 @@ async def list_documents(
                 id=doc.id,
                 trial_id=doc.trial_id,
                 site_id=doc.site_id,
+                etmf_node_id=doc.etmf_node_id,
                 doc_type=doc.doc_type,
                 title=doc.title,
                 scope_type=doc.scope_type,
@@ -228,6 +247,7 @@ async def get_document_detail(
         id=doc.id,
         trial_id=doc.trial_id,
         site_id=doc.site_id,
+        etmf_node_id=doc.etmf_node_id,
         doc_type=doc.doc_type,
         title=doc.title,
         scope_type=doc.scope_type,