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项目概览、参与者管理初步优化（未接入真实数据）

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This commit is contained in:
Cheng Zhou
2026-01-13 10:10:28 +08:00
parent 1338fa7e2b
commit b3cd8e03f2
37 changed files with 1785 additions and 118 deletions
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backend/app/api/v1/subject_histories.py
+1 -1
View File
@@ -34,7 +34,7 @@ async def create_history(
) -> SubjectHistoryRead:
await _ensure_study_exists(db, study_id)
if history_in.subject_id != subject_id:
raise HTTPException(status_code=status.HTTP_400_BAD_REQUEST, detail="受试者不匹配")
raise HTTPException(status_code=status.HTTP_400_BAD_REQUEST, detail="参与者不匹配")
history = await history_crud.create_history(db, study_id, history_in, created_by=current_user.id)
await audit_crud.log_action(
db,
backend/app/api/v1/subjects.py
+7 -7
View File
@@ -42,7 +42,7 @@ async def create_subject(
entity_type="subject",
entity_id=subject.id,
action="CREATE_SUBJECT",
detail=f"受试者 {subject.subject_no} 已创建",
detail=f"参与者 {subject.subject_no} 已创建",
operator_id=current_user.id,
operator_role=current_user.role,
)
@@ -81,7 +81,7 @@ async def get_subject(
await _ensure_study_exists(db, study_id)
subject = await subject_crud.get_subject(db, subject_id)
if not subject or subject.study_id != study_id:
raise HTTPException(status_code=status.HTTP_404_NOT_FOUND, detail="受试者不存在")
raise HTTPException(status_code=status.HTTP_404_NOT_FOUND, detail="参与者不存在")
return subject
@@ -100,7 +100,7 @@ async def update_subject(
await _ensure_study_exists(db, study_id)
subject = await subject_crud.get_subject(db, subject_id)
if not subject or subject.study_id != study_id:
raise HTTPException(status_code=status.HTTP_404_NOT_FOUND, detail="受试者不存在")
raise HTTPException(status_code=status.HTTP_404_NOT_FOUND, detail="参与者不存在")
old_status = subject.status
updated = await subject_crud.update_subject(db, subject, subject_in)
# auto-generate visits when enrolled
@@ -108,14 +108,14 @@ async def update_subject(
await subject_crud.generate_default_visits(db, updated)
detail = None
if subject_in.status and subject_in.status != old_status:
detail = f"受试者 {updated.subject_no} 状态 {old_status} -> {subject_in.status}"
detail = f"参与者 {updated.subject_no} 状态 {old_status} -> {subject_in.status}"
await audit_crud.log_action(
db,
study_id=study_id,
entity_type="subject",
entity_id=subject_id,
action="SUBJECT_STATUS_CHANGE" if detail else "UPDATE_SUBJECT",
detail=detail or "受试者已更新",
detail=detail or "参与者已更新",
operator_id=current_user.id,
operator_role=current_user.role,
)
@@ -136,7 +136,7 @@ async def delete_subject(
await _ensure_study_exists(db, study_id)
subject = await subject_crud.get_subject(db, subject_id)
if not subject or subject.study_id != study_id:
raise HTTPException(status_code=status.HTTP_404_NOT_FOUND, detail="受试者不存在")
raise HTTPException(status_code=status.HTTP_404_NOT_FOUND, detail="参与者不存在")
await subject_crud.delete_subject(db, subject)
await audit_crud.log_action(
db,
@@ -144,7 +144,7 @@ async def delete_subject(
entity_type="subject",
entity_id=subject_id,
action="DELETE_SUBJECT",
detail=f"受试者 {subject_id} 已删除",
detail=f"参与者 {subject_id} 已删除",
operator_id=current_user.id,
operator_role=current_user.role,
)
backend/app/api/v1/visits.py
+16 -3
View File
@@ -6,6 +6,7 @@ from sqlalchemy.ext.asyncio import AsyncSession
from app.core.deps import get_current_user, get_db_session, require_study_member, require_study_roles
from app.crud import audit as audit_crud
from app.crud import subject as subject_crud
from app.crud import study as study_crud
from app.crud import visit as visit_crud
from app.schemas.visit import VisitCreate, VisitRead, VisitUpdate
@@ -15,7 +16,7 @@ router = APIRouter()
async def _ensure_subject(db: AsyncSession, study_id: uuid.UUID, subject_id: uuid.UUID):
subject = await subject_crud.get_subject(db, subject_id)
if not subject or subject.study_id != study_id:
raise HTTPException(status_code=status.HTTP_404_NOT_FOUND, detail="受试者不存在")
raise HTTPException(status_code=status.HTTP_404_NOT_FOUND, detail="参与者不存在")
return subject
@@ -49,16 +50,28 @@ async def create_visit(
) -> VisitRead:
subject = await _ensure_subject(db, study_id, subject_id)
if visit_in.subject_id != subject_id:
raise HTTPException(status_code=status.HTTP_400_BAD_REQUEST, detail="受试者不匹配")
raise HTTPException(status_code=status.HTTP_400_BAD_REQUEST, detail="参与者不匹配")
visit = await visit_crud.create_visit(
db,
study_id=study_id,
visit_in=visit_in,
subject=subject,
visit_code=visit_in.visit_code,
visit_name=visit_in.visit_name,
planned_date=visit_in.planned_date,
)
if visit_in.visit_code == "V1" and visit_in.planned_date:
study = await study_crud.get(db, study_id)
if study:
await visit_crud.create_followup_visits(
db,
study_id=study_id,
subject=subject,
base_date=visit_in.planned_date,
visit_total=study.visit_total,
visit_interval_days=study.visit_interval_days,
window_start_offset=study.visit_window_start_offset,
window_end_offset=study.visit_window_end_offset,
)
await audit_crud.log_action(
db,
study_id=study_id,
backend/app/crud/ae.py
+1 -1
View File
@@ -28,7 +28,7 @@ async def _validate_site_subject(db: AsyncSession, study_id: uuid.UUID, site_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("受试者不属于当前项目")
raise ValueError("参与者不属于当前项目")
async def create_ae(
backend/app/crud/study.py
+4
View File
@@ -16,6 +16,10 @@ async def create(db: AsyncSession, study_in: StudyCreate, *, created_by: uuid.UU
protocol_no=study_in.protocol_no,
phase=study_in.phase,
status=study_in.status,
visit_interval_days=study_in.visit_interval_days,
visit_total=study_in.visit_total,
visit_window_start_offset=study_in.visit_window_start_offset,
visit_window_end_offset=study_in.visit_window_end_offset,
created_by=created_by,
)
db.add(study)
backend/app/crud/subject.py
+33 -12
View File
@@ -6,6 +6,8 @@ from sqlalchemy import select, update as sa_update
from sqlalchemy.ext.asyncio import AsyncSession
from app.crud import visit as visit_crud
from app.models.study import Study
from app.models.visit import Visit
from app.models.site import Site
from app.models.subject import Subject
from app.schemas.subject import SubjectCreate, SubjectUpdate
@@ -26,6 +28,7 @@ async def create_subject(db: AsyncSession, study_id: uuid.UUID, subject_in: Subj
subject_no=subject_in.subject_no,
status="SCREENING",
screening_date=subject_in.screening_date,
consent_date=subject_in.consent_date,
enrollment_date=None,
completion_date=None,
drop_reason=None,
@@ -41,7 +44,6 @@ async def create_subject(db: AsyncSession, study_id: uuid.UUID, subject_in: Subj
visit_in=None,
subject=subject,
visit_code="V0",
visit_name="Screening",
planned_date=subject.screening_date,
)
return subject
@@ -74,25 +76,44 @@ async def generate_default_visits(db: AsyncSession, subject: Subject) -> None:
# Baseline + Follow-up visits based on enrollment_date
if not subject.enrollment_date:
return
result = await db.execute(select(Study).where(Study.id == subject.study_id))
study = result.scalar_one_or_none()
if not study:
return
visit_total = study.visit_total or 3
visit_interval_days = study.visit_interval_days or 30
window_start_offset = study.visit_window_start_offset
window_end_offset = study.visit_window_end_offset
baseline_date = subject.enrollment_date
follow1 = baseline_date + timedelta(days=30)
follow2 = baseline_date + timedelta(days=60)
visits_data = [
("V1", "Baseline", baseline_date),
("FU1", "Follow-up 1", follow1),
("FU2", "Follow-up 2", follow2),
]
for code, name, plan_date in visits_data:
result = await db.execute(select(Visit.visit_code).where(Visit.subject_id == subject.id))
existing_codes = {row[0] for row in result.all()}
if "V1" not in existing_codes:
window_start = baseline_date + timedelta(days=window_start_offset) if window_start_offset is not None else None
window_end = baseline_date + timedelta(days=window_end_offset) if window_end_offset is not None else None
await visit_crud.create_visit(
db,
study_id=subject.study_id,
visit_in=None,
subject=subject,
visit_code=code,
visit_name=name,
planned_date=plan_date,
visit_code="V1",
planned_date=baseline_date,
window_start=window_start,
window_end=window_end,
)
await visit_crud.create_followup_visits(
db,
study_id=subject.study_id,
subject=subject,
base_date=baseline_date,
visit_total=visit_total,
visit_interval_days=visit_interval_days,
window_start_offset=window_start_offset,
window_end_offset=window_end_offset,
)
async def update_subject(db: AsyncSession, subject: Subject, subject_in: SubjectUpdate) -> Subject:
update_data = subject_in.model_dump(exclude_unset=True)
backend/app/crud/subject_history.py
+1 -1
View File
@@ -13,7 +13,7 @@ async def _ensure_subject(db: AsyncSession, study_id: uuid.UUID, subject_id: uui
result = await db.execute(select(Subject).where(Subject.id == subject_id))
subject = result.scalar_one_or_none()
if not subject or subject.study_id != study_id:
raise ValueError("受试者不属于当前项目")
raise ValueError("参与者不属于当前项目")
async def create_history(
backend/app/crud/visit.py
+52 -4
View File
@@ -1,4 +1,5 @@
import uuid
from datetime import date, timedelta
from typing import Sequence
from sqlalchemy import select, update as sa_update
@@ -16,19 +17,19 @@ async def create_visit(
visit_in: VisitCreate | None,
subject: Subject,
visit_code: str,
visit_name: str,
planned_date,
window_start: date | None = None,
window_end: date | None = None,
) -> Visit:
visit = Visit(
study_id=study_id,
subject_id=subject.id,
visit_code=visit_code,
visit_name=visit_name,
planned_date=planned_date,
actual_date=None,
status="PLANNED",
window_start=visit_in.window_start if visit_in else None,
window_end=visit_in.window_end if visit_in else None,
window_start=window_start if window_start is not None else (visit_in.window_start if visit_in else None),
window_end=window_end if window_end is not None else (visit_in.window_end if visit_in else None),
notes=None,
)
db.add(visit)
@@ -49,6 +50,12 @@ async def get_visit(db: AsyncSession, visit_id: uuid.UUID) -> Visit | None:
async def update_visit(db: AsyncSession, visit: Visit, visit_in: VisitUpdate) -> Visit:
update_data = visit_in.model_dump(exclude_unset=True)
if "actual_date" in update_data and update_data["actual_date"] is not None and "status" not in update_data:
actual_date = update_data["actual_date"]
if (visit.window_start and actual_date < visit.window_start) or (visit.window_end and actual_date > visit.window_end):
update_data["status"] = "OVERDUE"
else:
update_data["status"] = "DONE"
if update_data:
await db.execute(
sa_update(Visit)
@@ -63,3 +70,44 @@ async def update_visit(db: AsyncSession, visit: Visit, visit_in: VisitUpdate) ->
async def delete_visit(db: AsyncSession, visit: Visit) -> None:
await db.delete(visit)
await db.commit()
async def create_followup_visits(
db: AsyncSession,
*,
study_id: uuid.UUID,
subject: Subject,
base_date: date,
visit_total: int | None,
visit_interval_days: int | None,
window_start_offset: int | None,
window_end_offset: int | None,
) -> Sequence[Visit]:
if not visit_total or not visit_interval_days or visit_total < 2:
return []
result = await db.execute(select(Visit.visit_code).where(Visit.subject_id == subject.id))
existing_codes = {row[0] for row in result.all()}
created: list[Visit] = []
for index in range(2, visit_total + 1):
code = f"V{index}"
if code in existing_codes:
continue
planned_date = base_date + timedelta(days=visit_interval_days * (index - 1))
window_start = (
planned_date + timedelta(days=window_start_offset) if window_start_offset is not None else None
)
window_end = planned_date + timedelta(days=window_end_offset) if window_end_offset is not None else None
created.append(
await create_visit(
db,
study_id=study_id,
visit_in=None,
subject=subject,
visit_code=code,
planned_date=planned_date,
window_start=window_start,
window_end=window_end,
)
)
return created
backend/app/main.py
+1 -1
View File
@@ -75,7 +75,7 @@ def create_app() -> FastAPI:
{"name": "attachments", "description": "通用附件"},
{"name": "audit-logs", "description": "审计日志"},
{"name": "dashboard", "description": "项目总览与统计"},
{"name": "subjects", "description": "受试者"},
{"name": "subjects", "description": "参与者"},
{"name": "visits", "description": "访视"},
{"name": "aes", "description": "不良事件"},
{"name": "finance", "description": "费用管理"},
backend/app/models/study.py
+5 -1
View File
@@ -1,7 +1,7 @@
import uuid
from datetime import datetime
from sqlalchemy import DateTime, ForeignKey, String, func
from sqlalchemy import DateTime, ForeignKey, Integer, String, func
from sqlalchemy.dialects.postgresql import UUID
from sqlalchemy.orm import Mapped, mapped_column
@@ -18,5 +18,9 @@ class Study(Base):
protocol_no: Mapped[str | None] = mapped_column(String(100), nullable=True)
phase: Mapped[str | None] = mapped_column(String(50), nullable=True)
status: Mapped[str] = mapped_column(String(20), nullable=False, default="DRAFT")
visit_interval_days: Mapped[int | None] = mapped_column(Integer, nullable=True)
visit_total: Mapped[int | None] = mapped_column(Integer, nullable=True)
visit_window_start_offset: Mapped[int | None] = mapped_column(Integer, nullable=True)
visit_window_end_offset: Mapped[int | None] = mapped_column(Integer, nullable=True)
created_by: Mapped[uuid.UUID | None] = mapped_column(UUID(as_uuid=True), ForeignKey("users.id"), nullable=True)
created_at: Mapped[datetime] = mapped_column(DateTime(timezone=True), nullable=False, server_default=func.now())
backend/app/models/subject.py
+1
View File
@@ -18,6 +18,7 @@ class Subject(Base):
subject_no: Mapped[str] = mapped_column(String(50), nullable=False)
status: Mapped[str] = mapped_column(String(20), nullable=False, default="SCREENING")
screening_date: Mapped[date | None] = mapped_column(Date, nullable=True)
consent_date: Mapped[date | None] = mapped_column(Date, nullable=True)
enrollment_date: Mapped[date | None] = mapped_column(Date, nullable=True)
completion_date: Mapped[date | None] = mapped_column(Date, nullable=True)
drop_reason: Mapped[str | None] = mapped_column(Text, nullable=True)
backend/app/models/visit.py
-1
View File
@@ -15,7 +15,6 @@ class Visit(Base):
study_id: Mapped[uuid.UUID] = mapped_column(UUID(as_uuid=True), ForeignKey("studies.id"), nullable=False)
subject_id: Mapped[uuid.UUID] = mapped_column(UUID(as_uuid=True), ForeignKey("subjects.id"), index=True, nullable=False)
visit_code: Mapped[str] = mapped_column(String(50), nullable=False)
visit_name: Mapped[str] = mapped_column(String(200), nullable=False)
planned_date: Mapped[date | None] = mapped_column(Date, nullable=True)
actual_date: Mapped[date | None] = mapped_column(Date, nullable=True)
status: Mapped[str] = mapped_column(String(20), nullable=False, default="PLANNED")
backend/app/schemas/study.py
+12
View File
@@ -14,6 +14,10 @@ class StudyCreate(BaseModel):
protocol_no: Optional[str] = None
phase: Optional[str] = None
status: StudyStatus = "DRAFT"
visit_interval_days: Optional[int] = None
visit_total: Optional[int] = None
visit_window_start_offset: Optional[int] = None
visit_window_end_offset: Optional[int] = None
class StudyUpdate(BaseModel):
@@ -23,6 +27,10 @@ class StudyUpdate(BaseModel):
protocol_no: Optional[str] = None
phase: Optional[str] = None
status: Optional[StudyStatus] = None
visit_interval_days: Optional[int] = None
visit_total: Optional[int] = None
visit_window_start_offset: Optional[int] = None
visit_window_end_offset: Optional[int] = None
class StudyRead(BaseModel):
@@ -33,6 +41,10 @@ class StudyRead(BaseModel):
protocol_no: Optional[str]
phase: Optional[str]
status: StudyStatus
visit_interval_days: Optional[int]
visit_total: Optional[int]
visit_window_start_offset: Optional[int]
visit_window_end_offset: Optional[int]
created_by: Optional[uuid.UUID]
created_at: datetime
backend/app/schemas/subject.py
+3
View File
@@ -9,10 +9,12 @@ class SubjectCreate(BaseModel):
site_id: uuid.UUID
subject_no: str
screening_date: Optional[date] = None
consent_date: Optional[date] = None
class SubjectUpdate(BaseModel):
status: Optional[str] = None
consent_date: Optional[date] = None
enrollment_date: Optional[date] = None
completion_date: Optional[date] = None
drop_reason: Optional[str] = None
@@ -25,6 +27,7 @@ class SubjectRead(BaseModel):
subject_no: str
status: str
screening_date: Optional[date]
consent_date: Optional[date]
enrollment_date: Optional[date]
completion_date: Optional[date]
drop_reason: Optional[str]
backend/app/schemas/visit.py
-2
View File
@@ -8,7 +8,6 @@ from pydantic import BaseModel, ConfigDict
class VisitCreate(BaseModel):
subject_id: uuid.UUID
visit_code: str
visit_name: str
planned_date: Optional[date] = None
window_start: Optional[date] = None
window_end: Optional[date] = None
@@ -25,7 +24,6 @@ class VisitRead(BaseModel):
study_id: uuid.UUID
subject_id: uuid.UUID
visit_code: str
visit_name: str
planned_date: Optional[date]
actual_date: Optional[date]
status: str