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 +1,55 @@
+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)
@@ -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)