feat: harden auth and study workflows

- replace plaintext login and unlock requests with RSA-OAEP/AES-GCM encrypted payloads

- add login challenge replay protection, production RSA key validation, and auth tests

- wire compose to environment-driven dev/prod settings without committing local secrets

- update setup-config smoke scripts and Postman docs for encrypted login

- add visit schedule migrations/tests and update study/subject setup workflows
This commit is contained in:
Cheng Zhou
2026-05-08 22:13:12 +08:00
parent a7bbcaa5dc
commit 74feca4467
47 changed files with 2423 additions and 534 deletions
+26 -44
View File
@@ -1,5 +1,5 @@
import uuid
from datetime import date, timedelta
from datetime import date
from typing import Sequence
from sqlalchemy import delete as sa_delete, select, update as sa_update
@@ -37,6 +37,10 @@ def _validate_subject_date_chain(
raise ValueError("完成日期不能早于入组日期")
def _should_sync_visits(previous_baseline_date: date | None, next_baseline_date: date | None) -> bool:
return next_baseline_date is not None and previous_baseline_date != next_baseline_date
async def _validate_site(db: AsyncSession, study_id: uuid.UUID, site_id: uuid.UUID) -> None:
result = await db.execute(select(Site).where(Site.id == site_id))
site = result.scalar_one_or_none()
@@ -51,7 +55,7 @@ async def create_subject(db: AsyncSession, study_id: uuid.UUID, subject_in: Subj
_validate_subject_date_chain(
screening_date=subject_in.screening_date,
consent_date=subject_in.consent_date,
enrollment_date=None,
enrollment_date=subject_in.enrollment_date,
completion_date=None,
)
subject = Subject(
@@ -61,7 +65,8 @@ async def create_subject(db: AsyncSession, study_id: uuid.UUID, subject_in: Subj
status="SCREENING",
screening_date=subject_in.screening_date,
consent_date=subject_in.consent_date,
enrollment_date=None,
enrollment_date=subject_in.enrollment_date,
baseline_date=subject_in.baseline_date,
completion_date=None,
drop_reason=None,
)
@@ -69,15 +74,7 @@ async def create_subject(db: AsyncSession, study_id: uuid.UUID, subject_in: Subj
await db.commit()
await db.refresh(subject)
# initial visit: Screening (V0)
await visit_crud.create_visit(
db,
study_id=study_id,
visit_in=None,
subject=subject,
visit_code="V0",
planned_date=subject.screening_date,
)
await sync_visits_from_baseline(db, subject)
return subject
@@ -103,49 +100,26 @@ async def list_subjects(
return result.scalars().all()
async def generate_default_visits(db: AsyncSession, subject: Subject) -> None:
# Baseline + Follow-up visits based on enrollment_date
if not subject.enrollment_date:
return
async def sync_visits_from_baseline(db: AsyncSession, subject: Subject) -> None:
# 基线/治疗日期是访视计划的唯一推算基准,不能用入组日期替代。
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
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="V1",
planned_date=baseline_date,
window_start=window_start,
window_end=window_end,
)
await visit_crud.create_followup_visits(
await visit_crud.create_scheduled_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,
base_date=subject.baseline_date,
visit_schedule=study.visit_schedule,
)
async def generate_default_visits(db: AsyncSession, subject: Subject) -> None:
await sync_visits_from_baseline(db, subject)
async def update_subject(db: AsyncSession, subject: Subject, subject_in: SubjectUpdate) -> Subject:
update_data = subject_in.model_dump(exclude_unset=True)
next_screening_date = subject.screening_date
@@ -169,6 +143,14 @@ async def update_subject(db: AsyncSession, subject: Subject, subject_in: Subject
return subject
def should_generate_visits_after_subject_update(
*,
previous_baseline_date: date | None,
next_baseline_date: date | None,
) -> bool:
return _should_sync_visits(previous_baseline_date, next_baseline_date)
async def delete_subject(db: AsyncSession, subject: Subject) -> None:
subject_id = subject.id
await db.execute(sa_delete(Visit).where(Visit.subject_id == subject_id))