Cheng Zhou
143 lines
5.0 KiB
Python
143 lines
5.0 KiB
Python
import uuid
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from datetime import date, timedelta
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from typing import Sequence
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from sqlalchemy import delete as sa_delete, select, update as sa_update
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from sqlalchemy.ext.asyncio import AsyncSession
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from app.crud import visit as visit_crud
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from app.models.ae import AdverseEvent
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from app.models.finance import FinanceItem
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from app.models.study import Study
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from app.models.subject_history import SubjectHistory
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from app.models.visit import Visit
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from app.models.site import Site
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from app.models.subject import Subject
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from app.schemas.subject import SubjectCreate, SubjectUpdate
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async def _validate_site(db: AsyncSession, study_id: uuid.UUID, site_id: uuid.UUID) -> None:
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result = await db.execute(select(Site).where(Site.id == site_id))
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site = result.scalar_one_or_none()
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if not site or site.study_id != study_id:
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raise ValueError("分中心不属于当前项目")
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if not site.is_active:
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raise ValueError("中心已停用")
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async def create_subject(db: AsyncSession, study_id: uuid.UUID, subject_in: SubjectCreate) -> Subject:
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await _validate_site(db, study_id, subject_in.site_id)
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subject = Subject(
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study_id=study_id,
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site_id=subject_in.site_id,
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subject_no=subject_in.subject_no,
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status="SCREENING",
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screening_date=subject_in.screening_date,
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consent_date=subject_in.consent_date,
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enrollment_date=None,
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completion_date=None,
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drop_reason=None,
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)
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db.add(subject)
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await db.commit()
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await db.refresh(subject)
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# initial visit: Screening (V0)
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await visit_crud.create_visit(
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db,
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study_id=study_id,
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visit_in=None,
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subject=subject,
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visit_code="V0",
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planned_date=subject.screening_date,
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)
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return subject
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async def get_subject(db: AsyncSession, subject_id: uuid.UUID) -> Subject | None:
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result = await db.execute(select(Subject).where(Subject.id == subject_id))
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return result.scalar_one_or_none()
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async def list_subjects(
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db: AsyncSession,
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study_id: uuid.UUID,
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site_id: uuid.UUID | None = None,
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site_ids: set[uuid.UUID] | None = None,
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) -> Sequence[Subject]:
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stmt = select(Subject).where(Subject.study_id == study_id)
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if site_ids is not None:
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if not site_ids:
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return []
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stmt = stmt.where(Subject.site_id.in_(site_ids))
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if site_id:
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stmt = stmt.where(Subject.site_id == site_id)
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result = await db.execute(stmt)
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return result.scalars().all()
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async def generate_default_visits(db: AsyncSession, subject: Subject) -> None:
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# Baseline + Follow-up visits based on enrollment_date
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if not subject.enrollment_date:
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return
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result = await db.execute(select(Study).where(Study.id == subject.study_id))
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study = result.scalar_one_or_none()
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if not study:
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return
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visit_total = study.visit_total or 3
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visit_interval_days = study.visit_interval_days or 30
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window_start_offset = study.visit_window_start_offset
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window_end_offset = study.visit_window_end_offset
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baseline_date = subject.enrollment_date
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result = await db.execute(select(Visit.visit_code).where(Visit.subject_id == subject.id))
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existing_codes = {row[0] for row in result.all()}
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if "V1" not in existing_codes:
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window_start = baseline_date + timedelta(days=window_start_offset) if window_start_offset is not None else None
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window_end = baseline_date + timedelta(days=window_end_offset) if window_end_offset is not None else None
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await visit_crud.create_visit(
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db,
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study_id=subject.study_id,
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visit_in=None,
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subject=subject,
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visit_code="V1",
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planned_date=baseline_date,
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window_start=window_start,
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window_end=window_end,
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)
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await visit_crud.create_followup_visits(
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db,
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study_id=subject.study_id,
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subject=subject,
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base_date=baseline_date,
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visit_total=visit_total,
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visit_interval_days=visit_interval_days,
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window_start_offset=window_start_offset,
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window_end_offset=window_end_offset,
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)
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async def update_subject(db: AsyncSession, subject: Subject, subject_in: SubjectUpdate) -> Subject:
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update_data = subject_in.model_dump(exclude_unset=True)
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if update_data:
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await db.execute(
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sa_update(Subject)
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.where(Subject.id == subject.id)
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.values(**update_data)
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)
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await db.commit()
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await db.refresh(subject)
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return subject
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async def delete_subject(db: AsyncSession, subject: Subject) -> None:
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subject_id = subject.id
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await db.execute(sa_delete(Visit).where(Visit.subject_id == subject_id))
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await db.execute(sa_delete(SubjectHistory).where(SubjectHistory.subject_id == subject_id))
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await db.execute(sa_delete(AdverseEvent).where(AdverseEvent.subject_id == subject_id))
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await db.execute(sa_delete(FinanceItem).where(FinanceItem.subject_id == subject_id))
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await db.delete(subject)
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await db.commit()
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