参与者管理- PD模块内容补充
This commit is contained in:
Cheng Zhou
@@ -0,0 +1,75 @@
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"""add subject_pds table
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Revision ID: 20260228_01
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Revises: 20260227_06
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Create Date: 2026-02-28 10:30:00.000000
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"""
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from typing import Sequence, Union
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from alembic import op
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import sqlalchemy as sa
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from sqlalchemy.dialects import postgresql
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# revision identifiers, used by Alembic.
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revision: str = "20260228_01"
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down_revision: Union[str, None] = "20260227_06"
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branch_labels: Union[str, Sequence[str], None] = None
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depends_on: Union[str, Sequence[str], None] = None
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def upgrade() -> None:
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bind = op.get_bind()
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inspector = sa.inspect(bind)
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table_names = set(inspector.get_table_names())
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if "subject_pds" not in table_names:
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op.create_table(
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"subject_pds",
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sa.Column("id", postgresql.UUID(as_uuid=True), nullable=False),
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sa.Column("study_id", postgresql.UUID(as_uuid=True), nullable=False),
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sa.Column("subject_id", postgresql.UUID(as_uuid=True), nullable=False),
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sa.Column("pd_no", sa.String(length=64), nullable=False),
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sa.Column("pd_type", sa.String(length=100), nullable=False),
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sa.Column("pd_level", sa.String(length=20), nullable=False, server_default=sa.text("'GENERAL'")),
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sa.Column("approval_status", sa.String(length=20), nullable=False, server_default=sa.text("'DRAFT'")),
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sa.Column("description", sa.Text(), nullable=True),
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sa.Column("status", sa.String(length=20), nullable=False, server_default=sa.text("'OPEN'")),
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sa.Column("created_by", postgresql.UUID(as_uuid=True), nullable=True),
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sa.Column("created_at", sa.DateTime(timezone=True), nullable=False, server_default=sa.text("now()")),
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sa.Column("updated_at", sa.DateTime(timezone=True), nullable=False, server_default=sa.text("now()")),
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sa.ForeignKeyConstraint(["study_id"], ["studies.id"]),
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sa.ForeignKeyConstraint(["subject_id"], ["subjects.id"]),
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sa.ForeignKeyConstraint(["created_by"], ["users.id"]),
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sa.PrimaryKeyConstraint("id"),
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sa.UniqueConstraint("study_id", "pd_no", name="uq_subject_pds_study_pd_no"),
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)
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table_names.add("subject_pds")
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indexes = {idx["name"] for idx in inspector.get_indexes("subject_pds")} if "subject_pds" in table_names else set()
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study_index_name = op.f("ix_subject_pds_study_id")
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if study_index_name not in indexes:
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op.create_index(study_index_name, "subject_pds", ["study_id"], unique=False)
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subject_index_name = op.f("ix_subject_pds_subject_id")
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if subject_index_name not in indexes:
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op.create_index(subject_index_name, "subject_pds", ["subject_id"], unique=False)
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def downgrade() -> None:
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bind = op.get_bind()
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inspector = sa.inspect(bind)
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table_names = set(inspector.get_table_names())
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if "subject_pds" in table_names:
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indexes = {idx["name"] for idx in inspector.get_indexes("subject_pds")}
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study_index_name = op.f("ix_subject_pds_study_id")
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if study_index_name in indexes:
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op.drop_index(study_index_name, table_name="subject_pds")
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subject_index_name = op.f("ix_subject_pds_subject_id")
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if subject_index_name in indexes:
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op.drop_index(subject_index_name, table_name="subject_pds")
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op.drop_table("subject_pds")
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@@ -1,6 +1,6 @@
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from fastapi import APIRouter
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from app.api.v1 import auth, users, admin_users, studies, sites, members, attachments, audit_logs, dashboard, subjects, visits, aes, finance_dashboard, finance_contracts, finance_specials, fees_contracts, fees_specials, fees_attachments, drug_shipments, material_equipments, project_milestones, startup, knowledge_notes, subject_histories, faq_categories, faqs, documents, overview, notifications, monitoring_visit_issues
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from app.api.v1 import auth, users, admin_users, studies, sites, members, attachments, audit_logs, dashboard, subjects, visits, aes, finance_dashboard, finance_contracts, finance_specials, fees_contracts, fees_specials, fees_attachments, drug_shipments, material_equipments, project_milestones, startup, knowledge_notes, subject_histories, subject_pds, study_subject_pds, faq_categories, faqs, documents, overview, notifications, monitoring_visit_issues
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api_router = APIRouter()
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@@ -32,6 +32,8 @@ api_router.include_router(startup.router, prefix="/studies/{study_id}/startup",
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api_router.include_router(knowledge_notes.router, prefix="/studies/{study_id}/knowledge", tags=["knowledge"])
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api_router.include_router(monitoring_visit_issues.router, prefix="/studies/{study_id}/monitoring", tags=["monitoring-visit-issues"])
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api_router.include_router(subject_histories.router, prefix="/studies/{study_id}/subjects/{subject_id}", tags=["subject-histories"])
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api_router.include_router(subject_pds.router, prefix="/studies/{study_id}/subjects/{subject_id}", tags=["subject-pds"])
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api_router.include_router(study_subject_pds.router, prefix="/studies/{study_id}", tags=["subject-pds"])
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api_router.include_router(faq_categories.router, prefix="/faqs/categories", tags=["faq-categories"])
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api_router.include_router(faqs.router, prefix="/faqs/items", tags=["faqs"])
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api_router.include_router(documents.router, prefix="", tags=["documents"])
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@@ -0,0 +1,50 @@
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import uuid
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from fastapi import APIRouter, Depends, HTTPException, status
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from sqlalchemy.ext.asyncio import AsyncSession
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from app.core.deps import get_cra_site_scope, get_current_user, get_db_session, require_study_member
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from app.crud import study as study_crud
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from app.crud import subject_pd as subject_pd_crud
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from app.schemas.subject_pd import SubjectPdSummaryRead
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router = APIRouter()
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async def _ensure_study_exists(db: AsyncSession, study_id: uuid.UUID):
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study = await study_crud.get(db, study_id)
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if not study:
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raise HTTPException(status_code=status.HTTP_404_NOT_FOUND, detail="项目不存在")
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return study
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@router.get(
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"/subject-pds",
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response_model=list[SubjectPdSummaryRead],
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dependencies=[Depends(require_study_member())],
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)
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async def list_study_subject_pds(
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study_id: uuid.UUID,
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skip: int = 0,
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limit: int = 500,
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db: AsyncSession = Depends(get_db_session),
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current_user=Depends(get_current_user),
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) -> list[SubjectPdSummaryRead]:
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await _ensure_study_exists(db, study_id)
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cra_scope = await get_cra_site_scope(db, study_id, current_user)
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site_ids = cra_scope[0] if cra_scope else None
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rows = await subject_pd_crud.list_study_subject_pds(db, study_id, skip=skip, limit=limit, site_ids=site_ids)
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return [
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SubjectPdSummaryRead(
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id=item.id,
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study_id=item.study_id,
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subject_id=item.subject_id,
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subject_no=subject_no,
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site_id=site_id,
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pd_no=item.pd_no,
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status=item.status,
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description=item.description,
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updated_at=item.updated_at,
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)
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for item, subject_no, site_id in rows
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]
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@@ -0,0 +1,206 @@
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import uuid
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from fastapi import APIRouter, Depends, HTTPException, status
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from sqlalchemy.ext.asyncio import AsyncSession
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from app.core.deps import (
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get_current_user,
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get_db_session,
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require_study_member,
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require_study_not_locked,
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require_study_roles,
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)
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from app.crud import audit as audit_crud
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from app.crud import site as site_crud
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from app.crud import study as study_crud
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from app.crud import subject as subject_crud
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from app.crud import subject_pd as subject_pd_crud
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from app.schemas.subject_pd import SubjectPdCreate, SubjectPdRead, SubjectPdUpdate
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router = APIRouter()
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ALLOWED_PD_LEVELS = {"GENERAL", "MAJOR", "CRITICAL"}
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ALLOWED_APPROVAL_STATUS = {"DRAFT", "SUBMITTED", "APPROVED", "REJECTED"}
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ALLOWED_PD_STATUS = {"OPEN", "CLOSED"}
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async def _ensure_study_exists(db: AsyncSession, study_id: uuid.UUID):
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study = await study_crud.get(db, study_id)
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if not study:
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raise HTTPException(status_code=status.HTTP_404_NOT_FOUND, detail="项目不存在")
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return study
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async def _ensure_subject(db: AsyncSession, study_id: uuid.UUID, subject_id: uuid.UUID):
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subject = await subject_crud.get_subject(db, subject_id)
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if not subject or subject.study_id != study_id:
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raise HTTPException(status_code=status.HTTP_404_NOT_FOUND, detail="参与者不存在")
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return subject
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async def _ensure_subject_active(db: AsyncSession, subject) -> None:
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if not subject or not subject.site_id:
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return
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site = await site_crud.get_site(db, subject.site_id)
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if not site or not site.is_active:
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raise HTTPException(status_code=status.HTTP_403_FORBIDDEN, detail="中心已停用")
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def _normalize_pd_type(value: str) -> str:
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normalized = str(value or "").strip()
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if not normalized:
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raise HTTPException(status_code=status.HTTP_400_BAD_REQUEST, detail="PD类型不能为空")
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return normalized
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def _normalize_choice(value: str | None, allowed: set[str], field_name: str) -> str:
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if value is None:
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raise HTTPException(status_code=status.HTTP_400_BAD_REQUEST, detail=f"{field_name}不能为空")
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normalized = str(value).strip().upper()
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if normalized not in allowed:
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raise HTTPException(status_code=status.HTTP_400_BAD_REQUEST, detail=f"{field_name}取值无效")
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return normalized
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@router.get(
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"/pds",
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response_model=list[SubjectPdRead],
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dependencies=[Depends(require_study_member())],
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)
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async def list_subject_pds(
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study_id: uuid.UUID,
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subject_id: uuid.UUID,
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skip: int = 0,
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limit: int = 200,
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db: AsyncSession = Depends(get_db_session),
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) -> list[SubjectPdRead]:
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await _ensure_study_exists(db, study_id)
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await _ensure_subject(db, study_id, subject_id)
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items = await subject_pd_crud.list_subject_pds(db, study_id, subject_id, skip=skip, limit=limit)
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return [SubjectPdRead.model_validate(item) for item in items]
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@router.post(
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"/pds",
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response_model=SubjectPdRead,
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status_code=status.HTTP_201_CREATED,
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dependencies=[Depends(require_study_roles(["PM", "CRA"])), Depends(require_study_not_locked())],
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)
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async def create_subject_pd(
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study_id: uuid.UUID,
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subject_id: uuid.UUID,
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pd_in: SubjectPdCreate,
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db: AsyncSession = Depends(get_db_session),
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current_user=Depends(get_current_user),
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) -> SubjectPdRead:
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await _ensure_study_exists(db, study_id)
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subject = await _ensure_subject(db, study_id, subject_id)
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await _ensure_subject_active(db, subject)
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if pd_in.subject_id != subject_id:
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raise HTTPException(status_code=status.HTTP_400_BAD_REQUEST, detail="参与者不匹配")
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payload = pd_in.model_dump()
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payload["pd_type"] = _normalize_pd_type(payload.get("pd_type") or "")
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payload["pd_level"] = _normalize_choice(payload.get("pd_level") or "GENERAL", ALLOWED_PD_LEVELS, "PD分级")
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payload["approval_status"] = _normalize_choice(
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payload.get("approval_status") or "DRAFT", ALLOWED_APPROVAL_STATUS, "审批状态"
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)
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payload["status"] = _normalize_choice(payload.get("status") or "OPEN", ALLOWED_PD_STATUS, "状态")
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item = await subject_pd_crud.create_subject_pd(
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db,
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study_id,
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SubjectPdCreate(**payload),
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created_by=current_user.id,
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)
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await audit_crud.log_action(
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db,
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study_id=study_id,
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entity_type="subject_pd",
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entity_id=item.id,
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action="CREATE_SUBJECT_PD",
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detail=f"PD记录 {item.pd_no} 已创建",
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operator_id=current_user.id,
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operator_role=current_user.role,
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)
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return SubjectPdRead.model_validate(item)
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@router.patch(
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"/pds/{pd_id}",
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response_model=SubjectPdRead,
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dependencies=[Depends(require_study_roles(["PM", "CRA"])), Depends(require_study_not_locked())],
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)
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async def update_subject_pd(
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study_id: uuid.UUID,
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subject_id: uuid.UUID,
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pd_id: uuid.UUID,
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pd_in: SubjectPdUpdate,
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db: AsyncSession = Depends(get_db_session),
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current_user=Depends(get_current_user),
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) -> SubjectPdRead:
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await _ensure_study_exists(db, study_id)
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subject = await _ensure_subject(db, study_id, subject_id)
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await _ensure_subject_active(db, subject)
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item = await subject_pd_crud.get_subject_pd(db, pd_id)
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if not item or item.study_id != study_id or item.subject_id != subject_id:
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raise HTTPException(status_code=status.HTTP_404_NOT_FOUND, detail="PD记录不存在")
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update_payload = pd_in.model_dump(exclude_unset=True)
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if "pd_type" in update_payload:
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update_payload["pd_type"] = _normalize_pd_type(update_payload["pd_type"])
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if "pd_level" in update_payload:
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update_payload["pd_level"] = _normalize_choice(update_payload["pd_level"], ALLOWED_PD_LEVELS, "PD分级")
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if "approval_status" in update_payload:
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update_payload["approval_status"] = _normalize_choice(
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update_payload["approval_status"], ALLOWED_APPROVAL_STATUS, "审批状态"
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)
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if "status" in update_payload:
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update_payload["status"] = _normalize_choice(update_payload["status"], ALLOWED_PD_STATUS, "状态")
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updated = await subject_pd_crud.update_subject_pd(db, item, SubjectPdUpdate(**update_payload))
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await audit_crud.log_action(
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db,
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study_id=study_id,
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entity_type="subject_pd",
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entity_id=pd_id,
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action="UPDATE_SUBJECT_PD",
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detail=f"PD记录 {updated.pd_no} 已更新",
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operator_id=current_user.id,
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operator_role=current_user.role,
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)
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return SubjectPdRead.model_validate(updated)
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@router.delete(
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"/pds/{pd_id}",
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status_code=status.HTTP_204_NO_CONTENT,
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dependencies=[Depends(require_study_roles(["PM", "CRA"])), Depends(require_study_not_locked())],
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)
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async def delete_subject_pd(
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study_id: uuid.UUID,
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subject_id: uuid.UUID,
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pd_id: uuid.UUID,
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db: AsyncSession = Depends(get_db_session),
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current_user=Depends(get_current_user),
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) -> None:
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await _ensure_study_exists(db, study_id)
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subject = await _ensure_subject(db, study_id, subject_id)
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await _ensure_subject_active(db, subject)
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item = await subject_pd_crud.get_subject_pd(db, pd_id)
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if not item or item.study_id != study_id or item.subject_id != subject_id:
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raise HTTPException(status_code=status.HTTP_404_NOT_FOUND, detail="PD记录不存在")
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await subject_pd_crud.delete_subject_pd(db, item)
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await audit_crud.log_action(
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db,
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study_id=study_id,
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entity_type="subject_pd",
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entity_id=pd_id,
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action="DELETE_SUBJECT_PD",
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detail=f"PD记录 {item.pd_no} 已删除",
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operator_id=current_user.id,
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operator_role=current_user.role,
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)
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@@ -0,0 +1,120 @@
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import re
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import uuid
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from typing import Sequence
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from sqlalchemy import select, update as sa_update
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from sqlalchemy.ext.asyncio import AsyncSession
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from app.models.subject import Subject
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from app.models.subject_pd import SubjectPd
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from app.schemas.subject_pd import SubjectPdCreate, SubjectPdUpdate
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_PD_NO_PATTERN = re.compile(r"PD(\d+)$", re.IGNORECASE)
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def _extract_pd_sequence(pd_no: str | None) -> int:
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if not pd_no:
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return 0
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matched = _PD_NO_PATTERN.search(str(pd_no).strip())
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if not matched:
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return 0
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try:
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return int(matched.group(1))
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except ValueError:
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return 0
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async def _next_pd_no(db: AsyncSession, study_id: uuid.UUID) -> str:
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rows = await db.execute(select(SubjectPd.pd_no).where(SubjectPd.study_id == study_id))
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max_seq = 0
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for (pd_no,) in rows.all():
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max_seq = max(max_seq, _extract_pd_sequence(pd_no))
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return f"PD{max_seq + 1:04d}"
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async def list_subject_pds(
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db: AsyncSession,
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study_id: uuid.UUID,
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subject_id: uuid.UUID,
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*,
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skip: int = 0,
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limit: int = 200,
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) -> Sequence[SubjectPd]:
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||||
stmt = (
|
||||
select(SubjectPd)
|
||||
.where(SubjectPd.study_id == study_id, SubjectPd.subject_id == subject_id)
|
||||
.order_by(SubjectPd.pd_no.asc(), SubjectPd.created_at.asc())
|
||||
.offset(skip)
|
||||
.limit(limit)
|
||||
)
|
||||
rows = await db.execute(stmt)
|
||||
return rows.scalars().all()
|
||||
|
||||
|
||||
async def list_study_subject_pds(
|
||||
db: AsyncSession,
|
||||
study_id: uuid.UUID,
|
||||
*,
|
||||
skip: int = 0,
|
||||
limit: int = 500,
|
||||
site_ids: set[uuid.UUID] | None = None,
|
||||
) -> list[tuple[SubjectPd, str, uuid.UUID]]:
|
||||
if site_ids is not None and not site_ids:
|
||||
return []
|
||||
stmt = (
|
||||
select(SubjectPd, Subject.subject_no, Subject.site_id)
|
||||
.join(Subject, Subject.id == SubjectPd.subject_id)
|
||||
.where(
|
||||
SubjectPd.study_id == study_id,
|
||||
Subject.study_id == study_id,
|
||||
)
|
||||
.order_by(SubjectPd.pd_no.asc(), SubjectPd.created_at.asc())
|
||||
.offset(skip)
|
||||
.limit(limit)
|
||||
)
|
||||
if site_ids is not None:
|
||||
stmt = stmt.where(Subject.site_id.in_(site_ids))
|
||||
rows = await db.execute(stmt)
|
||||
return [(row[0], row[1], row[2]) for row in rows.all()]
|
||||
|
||||
|
||||
async def get_subject_pd(db: AsyncSession, pd_id: uuid.UUID) -> SubjectPd | None:
|
||||
row = await db.execute(select(SubjectPd).where(SubjectPd.id == pd_id))
|
||||
return row.scalar_one_or_none()
|
||||
|
||||
|
||||
async def create_subject_pd(
|
||||
db: AsyncSession,
|
||||
study_id: uuid.UUID,
|
||||
pd_in: SubjectPdCreate,
|
||||
*,
|
||||
created_by: uuid.UUID | None = None,
|
||||
) -> SubjectPd:
|
||||
payload = pd_in.model_dump(exclude_unset=True)
|
||||
# PD编号统一由后端按项目全局顺序生成，避免被外部覆盖。
|
||||
payload.pop("pd_no", None)
|
||||
pd_no = await _next_pd_no(db, study_id)
|
||||
item = SubjectPd(study_id=study_id, pd_no=pd_no, created_by=created_by, **payload)
|
||||
db.add(item)
|
||||
await db.commit()
|
||||
await db.refresh(item)
|
||||
return item
|
||||
|
||||
|
||||
async def update_subject_pd(db: AsyncSession, item: SubjectPd, pd_in: SubjectPdUpdate) -> SubjectPd:
|
||||
update_data = pd_in.model_dump(exclude_unset=True)
|
||||
if update_data:
|
||||
await db.execute(
|
||||
sa_update(SubjectPd)
|
||||
.where(SubjectPd.id == item.id)
|
||||
.values(**update_data)
|
||||
)
|
||||
await db.commit()
|
||||
await db.refresh(item)
|
||||
return item
|
||||
|
||||
|
||||
async def delete_subject_pd(db: AsyncSession, item: SubjectPd) -> None:
|
||||
await db.delete(item)
|
||||
await db.commit()
|
||||
@@ -13,6 +13,7 @@ from app.models.distribution import Distribution # noqa: F401
|
||||
from app.models.acknowledgement import Acknowledgement # noqa: F401
|
||||
from app.models.milestone import Milestone # noqa: F401
|
||||
from app.models.subject import Subject # noqa: F401
|
||||
from app.models.subject_pd import SubjectPd # noqa: F401
|
||||
from app.models.visit import Visit # noqa: F401
|
||||
from app.models.ae import AdverseEvent # noqa: F401
|
||||
from app.models.finance import FinanceItem # noqa: F401
|
||||
|
||||
@@ -0,0 +1,28 @@
|
||||
import uuid
|
||||
from datetime import datetime
|
||||
|
||||
from sqlalchemy import DateTime, ForeignKey, String, Text, UniqueConstraint, func
|
||||
from sqlalchemy.dialects.postgresql import UUID
|
||||
from sqlalchemy.orm import Mapped, mapped_column
|
||||
|
||||
from app.db.base_class import Base
|
||||
|
||||
|
||||
class SubjectPd(Base):
|
||||
__tablename__ = "subject_pds"
|
||||
__table_args__ = (UniqueConstraint("study_id", "pd_no", name="uq_subject_pds_study_pd_no"),)
|
||||
|
||||
id: Mapped[uuid.UUID] = mapped_column(UUID(as_uuid=True), primary_key=True, default=uuid.uuid4)
|
||||
study_id: Mapped[uuid.UUID] = mapped_column(UUID(as_uuid=True), ForeignKey("studies.id"), index=True, nullable=False)
|
||||
subject_id: Mapped[uuid.UUID] = mapped_column(UUID(as_uuid=True), ForeignKey("subjects.id"), index=True, nullable=False)
|
||||
pd_no: Mapped[str] = mapped_column(String(64), nullable=False)
|
||||
pd_type: Mapped[str] = mapped_column(String(100), nullable=False)
|
||||
pd_level: Mapped[str] = mapped_column(String(20), nullable=False, server_default="GENERAL")
|
||||
approval_status: Mapped[str] = mapped_column(String(20), nullable=False, server_default="DRAFT")
|
||||
description: Mapped[str | None] = mapped_column(Text, nullable=True)
|
||||
status: Mapped[str] = mapped_column(String(20), nullable=False, server_default="OPEN")
|
||||
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())
|
||||
updated_at: Mapped[datetime] = mapped_column(
|
||||
DateTime(timezone=True), nullable=False, server_default=func.now(), onupdate=func.now()
|
||||
)
|
||||
@@ -0,0 +1,52 @@
|
||||
import uuid
|
||||
from datetime import datetime
|
||||
from typing import Optional
|
||||
|
||||
from pydantic import BaseModel, ConfigDict
|
||||
|
||||
|
||||
class SubjectPdCreate(BaseModel):
|
||||
subject_id: uuid.UUID
|
||||
pd_no: Optional[str] = None
|
||||
pd_type: str
|
||||
pd_level: Optional[str] = "GENERAL"
|
||||
approval_status: Optional[str] = "DRAFT"
|
||||
description: Optional[str] = None
|
||||
status: Optional[str] = "OPEN"
|
||||
|
||||
|
||||
class SubjectPdUpdate(BaseModel):
|
||||
pd_type: Optional[str] = None
|
||||
pd_level: Optional[str] = None
|
||||
approval_status: Optional[str] = None
|
||||
description: Optional[str] = None
|
||||
status: Optional[str] = None
|
||||
|
||||
|
||||
class SubjectPdRead(BaseModel):
|
||||
id: uuid.UUID
|
||||
study_id: uuid.UUID
|
||||
subject_id: uuid.UUID
|
||||
pd_no: str
|
||||
pd_type: str
|
||||
pd_level: str
|
||||
approval_status: str
|
||||
description: Optional[str]
|
||||
status: str
|
||||
created_by: Optional[uuid.UUID]
|
||||
created_at: datetime
|
||||
updated_at: datetime
|
||||
|
||||
model_config = ConfigDict(from_attributes=True)
|
||||
|
||||
|
||||
class SubjectPdSummaryRead(BaseModel):
|
||||
id: uuid.UUID
|
||||
study_id: uuid.UUID
|
||||
subject_id: uuid.UUID
|
||||
subject_no: str
|
||||
site_id: uuid.UUID
|
||||
pd_no: str
|
||||
status: str
|
||||
description: Optional[str]
|
||||
updated_at: datetime
|
||||
Reference in New Issue
Block a user