新增电子试验主文件目录与文件归档

2026-05-28 10:54:13 +08:00
parent 31fcb7e6f2
commit fa961f1391
20 changed files with 2226 additions and 10 deletions
@@ -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,
@@ -0,0 +1,191 @@
+from __future__ import annotations
+
+import uuid
+from collections import defaultdict
+from typing import Iterable
+
+from fastapi import HTTPException, status
+from sqlalchemy import select
+from sqlalchemy.ext.asyncio import AsyncSession
+
+from app.crud import document as document_crud
+from app.crud import etmf as etmf_crud
+from app.models.document import Document, DocumentStatus
+from app.models.etmf import EtmfNode
+from app.models.audit_log import AuditLog
+from app.schemas.document import DocumentCreate, DocumentSummary
+from app.schemas.etmf import EtmfNodeCreate, EtmfNodeRead, EtmfNodeStatus, EtmfTreeNode, EtmfNodeUpdate
+
+
+def _role_value(user) -> str:
+    if user is None:
+        return "SYSTEM"
+    return user.role.value if hasattr(user.role, "value") else str(user.role)
+
+
+def calculate_node_status(node: EtmfNode, documents: Iterable[Document]) -> EtmfNodeStatus:
+    docs = list(documents)
+    if not node.is_active:
+        return EtmfNodeStatus.INACTIVE
+    if any(doc.current_effective_version_id for doc in docs):
+        return EtmfNodeStatus.EFFECTIVE
+    if docs:
+        return EtmfNodeStatus.UPLOADED
+    if node.required:
+        return EtmfNodeStatus.MISSING
+    return EtmfNodeStatus.NOT_REQUIRED
+
+
+def _tree_node(node: EtmfNode, documents: list[Document], children: list[EtmfTreeNode]) -> EtmfTreeNode:
+    return EtmfTreeNode(
+        id=node.id,
+        study_id=node.study_id,
+        parent_id=node.parent_id,
+        code=node.code,
+        name=node.name,
+        description=node.description,
+        scope_type=node.scope_type,
+        required=node.required,
+        expected_doc_type=node.expected_doc_type,
+        sort_order=node.sort_order,
+        is_active=node.is_active,
+        created_at=node.created_at,
+        updated_at=node.updated_at,
+        status=calculate_node_status(node, documents),
+        document_count=len(documents),
+        effective_document_count=sum(1 for doc in documents if doc.current_effective_version_id),
+        children=children,
+    )
+
+
+async def _documents_by_node(db: AsyncSession, study_id: uuid.UUID) -> dict[uuid.UUID, list[Document]]:
+    result = await db.execute(
+        select(Document).where(
+            Document.trial_id == study_id,
+            Document.etmf_node_id.is_not(None),
+            Document.status != DocumentStatus.ARCHIVED,
+        )
+    )
+    grouped: dict[uuid.UUID, list[Document]] = defaultdict(list)
+    for document in result.scalars().all():
+        if document.etmf_node_id:
+            grouped[document.etmf_node_id].append(document)
+    return grouped
+
+
+async def list_etmf_tree(db: AsyncSession, *, study_id: uuid.UUID, current_user) -> list[EtmfTreeNode]:
+    if current_user is not None:
+        from app.services import document_service
+
+        await document_service._ensure_study_access(db, study_id, current_user, action="view")
+    nodes = list(await etmf_crud.list_nodes_by_study(db, study_id))
+    documents = await _documents_by_node(db, study_id)
+    children_by_parent: dict[uuid.UUID | None, list[EtmfNode]] = defaultdict(list)
+    for node in nodes:
+        children_by_parent[node.parent_id].append(node)
+
+    def build(node: EtmfNode) -> EtmfTreeNode:
+        children = [build(child) for child in children_by_parent.get(node.id, [])]
+        return _tree_node(node, documents.get(node.id, []), children)
+
+    return [build(node) for node in children_by_parent.get(None, [])]
+
+
+async def create_node(db: AsyncSession, payload: EtmfNodeCreate, current_user) -> EtmfNode:
+    from app.services import document_service
+
+    await document_service._ensure_study_access(db, payload.study_id, current_user, action="create_document")
+    if payload.parent_id:
+        parent = await etmf_crud.get_node(db, payload.parent_id)
+        if not parent or parent.study_id != payload.study_id:
+            raise HTTPException(status_code=status.HTTP_400_BAD_REQUEST, detail="父级eTMF目录不存在或不属于当前项目")
+    node = EtmfNode(**payload.model_dump())
+    db.add(node)
+    db.add(
+        AuditLog(
+            study_id=payload.study_id,
+            entity_type="ETMF_NODE",
+            entity_id=node.id,
+            action="ETMF_NODE_CREATED",
+            detail=f'{{"code":"{node.code}","name":"{node.name}"}}',
+            operator_id=current_user.id,
+            operator_role=_role_value(current_user),
+        )
+    )
+    await db.commit()
+    await db.refresh(node)
+    return node
+
+
+async def update_node(db: AsyncSession, node_id: uuid.UUID, payload: EtmfNodeUpdate, current_user) -> EtmfNode:
+    from app.services import document_service
+
+    node = await etmf_crud.get_node(db, node_id)
+    if not node:
+        raise HTTPException(status_code=status.HTTP_404_NOT_FOUND, detail="eTMF目录不存在")
+    await document_service._ensure_study_access(db, node.study_id, current_user, action="create_version")
+    values = payload.model_dump(exclude_unset=True)
+    if "parent_id" in values and values["parent_id"]:
+        parent = await etmf_crud.get_node(db, values["parent_id"])
+        if not parent or parent.study_id != node.study_id or parent.id == node.id:
+            raise HTTPException(status_code=status.HTTP_400_BAD_REQUEST, detail="父级eTMF目录不合法")
+    await etmf_crud.update_node(db, node_id, values, commit=False)
+    db.add(
+        AuditLog(
+            study_id=node.study_id,
+            entity_type="ETMF_NODE",
+            entity_id=node.id,
+            action="ETMF_NODE_UPDATED",
+            detail="{}",
+            operator_id=current_user.id,
+            operator_role=_role_value(current_user),
+        )
+    )
+    await db.commit()
+    refreshed = await etmf_crud.get_node(db, node_id)
+    if not refreshed:
+        raise HTTPException(status_code=status.HTTP_404_NOT_FOUND, detail="eTMF目录不存在")
+    return refreshed
+
+
+async def list_node_documents(
+    db: AsyncSession,
+    *,
+    node_id: uuid.UUID,
+    site_id: uuid.UUID | None,
+    current_user,
+) -> list[DocumentSummary]:
+    from app.services import document_service
+
+    node = await etmf_crud.get_node(db, node_id)
+    if not node:
+        raise HTTPException(status_code=status.HTTP_404_NOT_FOUND, detail="eTMF目录不存在")
+    return await document_service.list_documents(
+        db,
+        trial_id=node.study_id,
+        site_id=site_id,
+        doc_type=None,
+        status=None,
+        scope_type=None,
+        etmf_node_id=node_id,
+        skip=0,
+        limit=500,
+        current_user=current_user,
+    )
+
+
+async def create_node_document(
+    db: AsyncSession,
+    *,
+    node_id: uuid.UUID,
+    payload: DocumentCreate,
+    current_user,
+) -> DocumentSummary:
+    from app.services import document_service
+
+    node = await etmf_crud.get_node(db, node_id)
+    if not node:
+        raise HTTPException(status_code=status.HTTP_404_NOT_FOUND, detail="eTMF目录不存在")
+    doc_payload = payload.model_copy(update={"trial_id": node.study_id, "etmf_node_id": node.id, "scope_type": node.scope_type})
+    document = await document_service.create_document(db, doc_payload, current_user)
+    return DocumentSummary.model_validate(document)