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

README.md

@@ -8,6 +8,9 @@
 - 对外入口：`nginx` 提供前端静态资源，并同域反代后端 API
 - 数据库 schema 来源：Alembic migration，不再依赖 `database/init.sql`
 - 默认无任何业务预置数据；生产初始化只确保固定管理员 `admin@huapont.cn / admin123` 存在
+- 生产环境必须配置 `LOGIN_RSA_PRIVATE_KEY`；登录密码传输使用 RSA-OAEP 包裹 AES-GCM 密钥，数据库仍只保存 bcrypt 哈希
+- 浏览器端加密依赖 WebCrypto 安全上下文；生产访问必须使用 HTTPS，本地 `localhost` 例外
+- 当前 challenge 缓存在后端进程内，默认最多保留 1000 个；多实例或多 worker 部署需改为共享缓存或启用粘性会话
 - 验证方式：
   - `docker compose config`
   - `curl -i http://127.0.0.1:8888/`
@@ -34,6 +37,7 @@
 
 ## 仓库治理文档
 - 分支治理规范：`docs/branch-governance.md`
+- 分支环境安装配置：`docs/guides/branch-environment-installation.md`
 - 发布检查清单：`docs/guides/release-checklist.md`
 
 ## 本地配置
@@ -57,6 +61,6 @@
 > ADMIN 具备所有 PM 权限，项目内操作与 PM 同步放行。
 
 ## 注意
-- 登录使用邮箱 + 密码，未审核/已拒绝/已停用账号无法登录。
+- 登录使用邮箱 + 密码，前端会先获取登录公钥并加密提交；未审核/已拒绝/已停用账号无法登录。
 - 令牌与当前项目上下文保存在浏览器 LocalStorage 中，清除后需重新登录/选择项目。
 - 若后端重启，确认数据库容器仍健康，前端会弹出错误提示。

backend/alembic/versions/20260508_01_replace_global_visit_window.py

@@ -0,0 +1,43 @@
+"""replace global visit window with per-visit schedule
+
+Revision ID: 20260508_01
+Revises: 20260331_01
+Create Date: 2026-05-08 11:30:00.000000
+
+"""
+
+from typing import Sequence, Union
+
+from alembic import op
+import sqlalchemy as sa
+from sqlalchemy.dialects import postgresql
+
+
+revision: str = "20260508_01"
+down_revision: Union[str, None] = "20260331_01"
+branch_labels: Union[str, Sequence[str], None] = None
+depends_on: Union[str, Sequence[str], None] = None
+
+
+def upgrade() -> None:
+    op.add_column(
+        "studies",
+        sa.Column(
+            "visit_schedule",
+            postgresql.JSONB(astext_type=sa.Text()),
+            nullable=False,
+            server_default=sa.text("'[]'::jsonb"),
+        ),
+    )
+    op.drop_column("studies", "visit_window_end_offset")
+    op.drop_column("studies", "visit_window_start_offset")
+    op.drop_column("studies", "visit_total")
+    op.drop_column("studies", "visit_interval_days")
+
+
+def downgrade() -> None:
+    op.add_column("studies", sa.Column("visit_interval_days", sa.Integer(), nullable=True))
+    op.add_column("studies", sa.Column("visit_total", sa.Integer(), nullable=True))
+    op.add_column("studies", sa.Column("visit_window_start_offset", sa.Integer(), nullable=True))
+    op.add_column("studies", sa.Column("visit_window_end_offset", sa.Integer(), nullable=True))
+    op.drop_column("studies", "visit_schedule")

backend/alembic/versions/20260508_02_remove_summary_objective_notes.py

@@ -0,0 +1,47 @@
+"""remove summary and objective note fields
+
+Revision ID: 20260508_02
+Revises: 20260508_01
+Create Date: 2026-05-08 15:55:00.000000
+
+"""
+
+from typing import Sequence, Union
+
+from alembic import op
+import sqlalchemy as sa
+
+
+revision: str = "20260508_02"
+down_revision: Union[str, None] = "20260508_01"
+branch_labels: Union[str, Sequence[str], None] = None
+depends_on: Union[str, Sequence[str], None] = None
+
+
+def upgrade() -> None:
+    bind = op.get_bind()
+    bind.execute(
+        sa.text(
+            """
+            UPDATE study_setup_configs
+            SET published_project_snapshot = published_project_snapshot - 'summary_note' - 'objective_note'
+            WHERE published_project_snapshot IS NOT NULL
+            """
+        )
+    )
+    bind.execute(
+        sa.text(
+            """
+            UPDATE study_setup_config_versions
+            SET published_project_snapshot = published_project_snapshot - 'summary_note' - 'objective_note'
+            WHERE published_project_snapshot IS NOT NULL
+            """
+        )
+    )
+    op.drop_column("studies", "objective_note")
+    op.drop_column("studies", "summary_note")
+
+
+def downgrade() -> None:
+    op.add_column("studies", sa.Column("summary_note", sa.Text(), nullable=True))
+    op.add_column("studies", sa.Column("objective_note", sa.Text(), nullable=True))

backend/alembic/versions/20260508_03_add_subject_baseline_date.py

@@ -0,0 +1,26 @@
+"""add subject baseline date
+
+Revision ID: 20260508_03
+Revises: 20260508_02
+Create Date: 2026-05-08 16:35:00.000000
+
+"""
+
+from typing import Sequence, Union
+
+from alembic import op
+import sqlalchemy as sa
+
+
+revision: str = "20260508_03"
+down_revision: Union[str, None] = "20260508_02"
+branch_labels: Union[str, Sequence[str], None] = None
+depends_on: Union[str, Sequence[str], None] = None
+
+
+def upgrade() -> None:
+    op.add_column("subjects", sa.Column("baseline_date", sa.Date(), nullable=True))
+
+
+def downgrade() -> None:
+    op.drop_column("subjects", "baseline_date")

backend/app/api/v1/auth.py

@@ -1,12 +1,13 @@
 from datetime import datetime, timedelta, timezone
 from fastapi import APIRouter, Depends, HTTPException, status
 from fastapi import File, UploadFile
-from pydantic import BaseModel, EmailStr, Field
+from pydantic import BaseModel, Field
 from sqlalchemy.ext.asyncio import AsyncSession
 from pathlib import Path
 import uuid
 
 from app.core.config import settings
+from app.core.login_crypto import create_login_challenge, decrypt_login_payload, get_public_key_pem
 from app.core.security import create_access_token, decode_token_allow_expired, oauth2_scheme, verify_password
 from app.core.deps import get_current_user, get_db_session
 from app.crud import user as user_crud
@@ -16,8 +17,16 @@ from fastapi.responses import FileResponse
 
 
 class LoginRequest(BaseModel):
-    email: EmailStr
-    password: str = Field(min_length=1)
+    key_id: str = Field(min_length=1)
+    challenge: str = Field(min_length=16)
+    ciphertext: str = Field(min_length=1)
+
+
+class LoginKeyResponse(BaseModel):
+    key_id: str
+    public_key: str
+    challenge: str
+    expires_at: datetime
 
 
 class ExtendResponse(BaseModel):
@@ -25,9 +34,8 @@ class ExtendResponse(BaseModel):
     expiresAt: datetime
 
 
-class UnlockRequest(BaseModel):
-    email: EmailStr
-    password: str = Field(min_length=1)
+class UnlockRequest(LoginRequest):
+    pass
 
 
 class UnlockResponse(BaseModel):
@@ -40,6 +48,42 @@ AVATAR_ROOT = Path(__file__).resolve().parent.parent.parent / "uploads" / "avata
 AVATAR_ROOT.mkdir(parents=True, exist_ok=True)
 
 
+def issue_user_token(db_user) -> Token:
+    session_start = datetime.now(timezone.utc)
+    access_token = create_access_token(
+        user_id=str(db_user.id),
+        role=db_user.role.value if hasattr(db_user.role, "value") else db_user.role,
+        expires_minutes=None,
+        session_start=session_start,
+    )
+    return Token(access_token=access_token, token_type="bearer")
+
+
+async def authenticate_encrypted_password(payload: LoginRequest, db: AsyncSession):
+    decrypted = decrypt_login_payload(
+        key_id=payload.key_id,
+        challenge=payload.challenge,
+        ciphertext=payload.ciphertext,
+    )
+    if not decrypted:
+        raise HTTPException(
+            status_code=status.HTTP_401_UNAUTHORIZED,
+            detail="无法验证登录凭据",
+        )
+    db_user = await user_crud.get_by_email(db, decrypted.email)
+    if not db_user:
+        raise HTTPException(
+            status_code=status.HTTP_401_UNAUTHORIZED,
+            detail="账号不存在",
+        )
+    if not verify_password(decrypted.password, db_user.password_hash):
+        raise HTTPException(
+            status_code=status.HTTP_401_UNAUTHORIZED,
+            detail="密码错误",
+        )
+    return db_user
+
+
 @router.post("/register", status_code=status.HTTP_201_CREATED)
 async def register(
     payload: UserRegisterRequest,
@@ -54,35 +98,29 @@ async def register(
     return {"message": "注册成功，等待管理员审核"}
 
 
+@router.get("/login-key", response_model=LoginKeyResponse)
+async def get_login_key() -> LoginKeyResponse:
+    challenge = create_login_challenge()
+    return LoginKeyResponse(
+        key_id=settings.LOGIN_RSA_KEY_ID,
+        public_key=get_public_key_pem(),
+        challenge=challenge.value,
+        expires_at=challenge.expires_at,
+    )
+
+
 @router.post("/login", response_model=Token)
 async def login_for_access_token(
     payload: LoginRequest, db: AsyncSession = Depends(get_db_session)
 ) -> Token:
-    db_user = await user_crud.get_by_email(db, payload.email)
-    if not db_user:
-        raise HTTPException(
-            status_code=status.HTTP_401_UNAUTHORIZED,
-            detail="账号不存在",
-        )
-    if not verify_password(payload.password, db_user.password_hash):
-        raise HTTPException(
-            status_code=status.HTTP_401_UNAUTHORIZED,
-            detail="密码错误",
-        )
+    db_user = await authenticate_encrypted_password(payload, db)
     if db_user.status != UserStatus.ACTIVE:
         raise HTTPException(
             status_code=status.HTTP_401_UNAUTHORIZED,
             detail="账号未审核或不可用",
         )
 
-    session_start = datetime.now(timezone.utc)
-    access_token = create_access_token(
-        user_id=str(db_user.id),
-        role=db_user.role.value if hasattr(db_user.role, "value") else db_user.role,
-        expires_minutes=None,
-        session_start=session_start,
-    )
-    return Token(access_token=access_token, token_type="bearer")
+    return issue_user_token(db_user)
 
 
 @router.get("/me", response_model=UserRead)
@@ -133,11 +171,7 @@ async def unlock_session(
     payload: UnlockRequest,
     db: AsyncSession = Depends(get_db_session),
 ) -> UnlockResponse:
-    db_user = await user_crud.get_by_email(db, payload.email)
-    if not db_user:
-        raise HTTPException(status_code=status.HTTP_401_UNAUTHORIZED, detail="账号不存在")
-    if not verify_password(payload.password, db_user.password_hash):
-        raise HTTPException(status_code=status.HTTP_401_UNAUTHORIZED, detail="密码错误")
+    db_user = await authenticate_encrypted_password(payload, db)
     if db_user.status != UserStatus.ACTIVE:
         raise HTTPException(status_code=status.HTTP_403_FORBIDDEN, detail="账号已停用")
     session_start = datetime.now(timezone.utc)

backend/app/api/v1/studies.py

@@ -283,13 +283,8 @@ def _build_project_publish_snapshot(study) -> ProjectPublishSnapshot:
         plan_end_date=_to_date_text(getattr(study, "plan_end_date", None)),
         planned_site_count=getattr(study, "planned_site_count", None),
         planned_enrollment_count=getattr(study, "planned_enrollment_count", None),
-        summary_note=getattr(study, "summary_note", None) or "",
-        objective_note=getattr(study, "objective_note", None) or "",
         status=getattr(study, "status", None) or "",
-        visit_interval_days=getattr(study, "visit_interval_days", None),
-        visit_total=getattr(study, "visit_total", None),
-        visit_window_start_offset=getattr(study, "visit_window_start_offset", None),
-        visit_window_end_offset=getattr(study, "visit_window_end_offset", None),
+        visit_schedule=getattr(study, "visit_schedule", None) or [],
     )
 
 
@@ -360,17 +355,9 @@ def _ensure_study_timeline_valid(
     *,
     plan_start_date: date | None,
     plan_end_date: date | None,
-    visit_window_start_offset: int | None,
-    visit_window_end_offset: int | None,
 ) -> None:
     if plan_start_date and plan_end_date and plan_start_date > plan_end_date:
         raise HTTPException(status_code=status.HTTP_400_BAD_REQUEST, detail="项目计划结束日期不能早于开始日期")
-    if (
-        visit_window_start_offset is not None
-        and visit_window_end_offset is not None
-        and visit_window_start_offset > visit_window_end_offset
-    ):
-        raise HTTPException(status_code=status.HTTP_400_BAD_REQUEST, detail="访视窗口开始偏移不能晚于结束偏移")
 
 
 def _resolve_version_label(record: Any) -> str:
@@ -649,8 +636,6 @@ async def create_study(
     _ensure_study_timeline_valid(
         plan_start_date=study_in.plan_start_date,
         plan_end_date=study_in.plan_end_date,
-        visit_window_start_offset=study_in.visit_window_start_offset,
-        visit_window_end_offset=study_in.visit_window_end_offset,
     )
     study_in.code = study_in.code.strip()
     if not study_in.code:
@@ -746,21 +731,9 @@ async def update_study(
 
     next_plan_start = study_in.plan_start_date if "plan_start_date" in study_in.model_fields_set else study.plan_start_date
     next_plan_end = study_in.plan_end_date if "plan_end_date" in study_in.model_fields_set else study.plan_end_date
-    next_window_start = (
-        study_in.visit_window_start_offset
-        if "visit_window_start_offset" in study_in.model_fields_set
-        else study.visit_window_start_offset
-    )
-    next_window_end = (
-        study_in.visit_window_end_offset
-        if "visit_window_end_offset" in study_in.model_fields_set
-        else study.visit_window_end_offset
-    )
     _ensure_study_timeline_valid(
         plan_start_date=next_plan_start,
         plan_end_date=next_plan_end,
-        visit_window_start_offset=next_window_start,
-        visit_window_end_offset=next_window_end,
     )
     
     updated = await study_crud.update(db, study, study_in)

backend/app/api/v1/subjects.py

@@ -173,9 +173,9 @@ async def update_subject(
     await _ensure_subject_active(db, subject)
     old_status = subject.status
     updated = await subject_crud.update_subject(db, subject, subject_in)
-    # auto-generate visits when enrolled
-    if subject_in.status and subject_in.status == "ENROLLED" and (subject_in.enrollment_date or updated.enrollment_date):
-        await subject_crud.generate_default_visits(db, updated)
+    # 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。
+    if updated.baseline_date:
+        await subject_crud.sync_visits_from_baseline(db, updated)
     detail = None
     if subject_in.status and subject_in.status != old_status:
         detail = f"参与者 {updated.subject_no} 状态 {old_status} -> {subject_in.status}"

backend/app/api/v1/visits.py

@@ -90,15 +90,12 @@ async def create_visit(
     if next_visit_code == "V1" and visit_in.planned_date:
         study = await study_crud.get(db, study_id)
         if study:
-            await visit_crud.create_followup_visits(
+            await visit_crud.create_scheduled_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,
+                visit_schedule=study.visit_schedule,
             )
     await audit_crud.log_action(
         db,

backend/app/core/config.py

@@ -1,5 +1,5 @@
 from functools import lru_cache
-from typing import Literal
+from typing import Literal, Optional
 
 from pydantic import Field
 from pydantic_settings import BaseSettings, SettingsConfigDict
@@ -19,6 +19,11 @@ class Settings(BaseSettings):
     JWT_EXPIRE_MINUTES: int = 60
     JWT_EXTEND_GRACE_SECONDS: int = 120
     ABSOLUTE_SESSION_MAX_HOURS: int = 8
+    LOGIN_RSA_PRIVATE_KEY: Optional[str] = None
+    LOGIN_RSA_PUBLIC_KEY: Optional[str] = None
+    LOGIN_RSA_KEY_ID: str = "default"
+    LOGIN_CHALLENGE_TTL_SECONDS: int = 120
+    LOGIN_CHALLENGE_MAX_ACTIVE: int = 1000
 
 
 @lru_cache

backend/app/core/login_crypto.py

@@ -0,0 +1,138 @@
+import base64
+import json
+import secrets
+from dataclasses import dataclass
+from datetime import datetime, timedelta, timezone
+from typing import Any
+
+from cryptography.hazmat.primitives import hashes, serialization
+from cryptography.hazmat.primitives.asymmetric import padding, rsa
+from cryptography.hazmat.primitives.asymmetric.rsa import RSAPrivateKey, RSAPublicKey
+from cryptography.hazmat.primitives.ciphers.aead import AESGCM
+from pydantic import BaseModel, EmailStr, Field, ValidationError
+
+from app.core.config import settings
+
+
+class DecryptedLoginPayload(BaseModel):
+    email: EmailStr
+    password: str = Field(min_length=1, max_length=72)
+    challenge: str = Field(min_length=16)
+
+
+class EncryptedLoginEnvelope(BaseModel):
+    encrypted_key: str = Field(min_length=1)
+    iv: str = Field(min_length=1)
+    data: str = Field(min_length=1)
+
+
+@dataclass(frozen=True)
+class LoginChallenge:
+    value: str
+    expires_at: datetime
+
+
+_private_key: RSAPrivateKey | None = None
+_public_key_pem: str | None = None
+_challenges: dict[str, LoginChallenge] = {}
+
+
+def _normalize_pem(value: str) -> str:
+    return value.replace("\\n", "\n").strip()
+
+
+def _load_or_create_private_key() -> RSAPrivateKey:
+    configured_key = settings.LOGIN_RSA_PRIVATE_KEY
+    if configured_key:
+        key = serialization.load_pem_private_key(_normalize_pem(configured_key).encode("utf-8"), password=None)
+        if not isinstance(key, RSAPrivateKey):
+            raise ValueError("LOGIN_RSA_PRIVATE_KEY 必须是 RSA 私钥")
+        return key
+    if settings.ENV == "production":
+        raise ValueError("生产环境必须配置 LOGIN_RSA_PRIVATE_KEY")
+    return rsa.generate_private_key(public_exponent=65537, key_size=2048)
+
+
+def get_private_key() -> RSAPrivateKey:
+    global _private_key
+    if _private_key is None:
+        _private_key = _load_or_create_private_key()
+    return _private_key
+
+
+def validate_login_crypto_configuration() -> None:
+    if settings.ENV == "production" and not settings.LOGIN_RSA_PRIVATE_KEY:
+        raise ValueError("生产环境必须配置 LOGIN_RSA_PRIVATE_KEY")
+
+
+def get_public_key_pem() -> str:
+    global _public_key_pem
+    if _public_key_pem is not None:
+        return _public_key_pem
+    if settings.LOGIN_RSA_PUBLIC_KEY:
+        if not settings.LOGIN_RSA_PRIVATE_KEY:
+            raise ValueError("配置 LOGIN_RSA_PUBLIC_KEY 时必须同时配置 LOGIN_RSA_PRIVATE_KEY")
+        _public_key_pem = _normalize_pem(settings.LOGIN_RSA_PUBLIC_KEY)
+        return _public_key_pem
+    public_key: RSAPublicKey = get_private_key().public_key()
+    _public_key_pem = public_key.public_bytes(
+        encoding=serialization.Encoding.PEM,
+        format=serialization.PublicFormat.SubjectPublicKeyInfo,
+    ).decode("utf-8")
+    return _public_key_pem
+
+
+def create_login_challenge() -> LoginChallenge:
+    prune_expired_challenges()
+    while len(_challenges) >= settings.LOGIN_CHALLENGE_MAX_ACTIVE:
+        oldest = next(iter(_challenges))
+        _challenges.pop(oldest, None)
+    value = secrets.token_urlsafe(32)
+    expires_at = datetime.now(timezone.utc) + timedelta(seconds=settings.LOGIN_CHALLENGE_TTL_SECONDS)
+    challenge = LoginChallenge(value=value, expires_at=expires_at)
+    _challenges[value] = challenge
+    return challenge
+
+
+def prune_expired_challenges() -> None:
+    now = datetime.now(timezone.utc)
+    expired = [value for value, challenge in _challenges.items() if challenge.expires_at <= now]
+    for value in expired:
+        _challenges.pop(value, None)
+
+
+def consume_login_challenge(value: str) -> bool:
+    prune_expired_challenges()
+    challenge = _challenges.pop(value, None)
+    if not challenge:
+        return False
+    return challenge.expires_at > datetime.now(timezone.utc)
+
+
+def decrypt_login_payload(*, key_id: str, challenge: str, ciphertext: str) -> DecryptedLoginPayload | None:
+    if key_id != settings.LOGIN_RSA_KEY_ID:
+        return None
+    if not consume_login_challenge(challenge):
+        return None
+    try:
+        envelope_data = json.loads(base64.b64decode(ciphertext, validate=True).decode("utf-8"))
+        envelope = EncryptedLoginEnvelope.model_validate(envelope_data)
+        encrypted_key = base64.b64decode(envelope.encrypted_key, validate=True)
+        iv = base64.b64decode(envelope.iv, validate=True)
+        encrypted_payload = base64.b64decode(envelope.data, validate=True)
+        aes_key = get_private_key().decrypt(
+            encrypted_key,
+            padding.OAEP(
+                mgf=padding.MGF1(algorithm=hashes.SHA256()),
+                algorithm=hashes.SHA256(),
+                label=None,
+            ),
+        )
+        decrypted = AESGCM(aes_key).decrypt(iv, encrypted_payload, None)
+        payload: Any = json.loads(decrypted.decode("utf-8"))
+        parsed = DecryptedLoginPayload.model_validate(payload)
+    except (ValueError, TypeError, json.JSONDecodeError, ValidationError):
+        return None
+    if parsed.challenge != challenge:
+        return None
+    return parsed

backend/app/crud/study.py

@@ -30,14 +30,9 @@ async def create(db: AsyncSession, study_in: StudyCreate, *, created_by: uuid.UU
         planned_enrollment_count=study_in.planned_enrollment_count,
         enrollment_monthly_goal_note=study_in.enrollment_monthly_goal_note,
         enrollment_stage_breakdown=study_in.enrollment_stage_breakdown,
-        summary_note=study_in.summary_note,
-        objective_note=study_in.objective_note,
         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,
+        visit_schedule=[item.model_dump() for item in study_in.visit_schedule],
         created_by=created_by,
     )
     db.add(study)

backend/app/crud/subject.py

@@ -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))

backend/app/crud/visit.py

@@ -5,11 +5,59 @@ from typing import Sequence
 from sqlalchemy import and_, func, or_, select, update as sa_update
 from sqlalchemy.ext.asyncio import AsyncSession
 
+from app.models.study import Study
 from app.models.subject import Subject
 from app.models.visit import Visit
 from app.schemas.visit import VisitCreate, VisitUpdate
 
 
+def _visit_schedule_order_map(visit_schedule: list[dict] | None) -> dict[str, int]:
+    order_map: dict[str, int] = {}
+    for index, item in enumerate(visit_schedule or []):
+        code = str(item.get("visit_code") or "").strip()
+        if code and code not in order_map:
+            order_map[code] = index
+    return order_map
+
+
+def sort_visits_for_display(visits: Sequence[Visit], visit_schedule: list[dict] | None = None) -> list[Visit]:
+    order_map = _visit_schedule_order_map(visit_schedule)
+    fallback_start = len(order_map)
+    return sorted(
+        visits,
+        key=lambda visit: (
+            order_map.get((visit.visit_code or "").strip(), fallback_start),
+            visit.planned_date is None,
+            visit.planned_date or date.max,
+            visit.visit_code or "",
+        ),
+    )
+
+
+def build_visit_schedule_dates(visit_schedule: list[dict] | None, base_date: date | None) -> list[dict]:
+    if not visit_schedule:
+        return []
+    rows: list[dict] = []
+    for item in visit_schedule:
+        code = str(item.get("visit_code") or "").strip()
+        if not code:
+            continue
+        baseline_offset_days = int(item.get("baseline_offset_days", 0))
+        window_before_days = int(item.get("window_before_days", 0))
+        window_after_days = int(item.get("window_after_days", 0))
+        planned_date = base_date + timedelta(days=baseline_offset_days) if base_date else None
+        rows.append(
+            {
+                "visit_code": code,
+                "baseline_offset_days": baseline_offset_days,
+                "planned_date": planned_date,
+                "window_start": planned_date - timedelta(days=window_before_days) if planned_date else None,
+                "window_end": planned_date + timedelta(days=window_after_days) if planned_date else None,
+            }
+        )
+    return rows
+
+
 async def create_visit(
     db: AsyncSession,
     *,
@@ -20,14 +68,16 @@ async def create_visit(
     planned_date,
     window_start: date | None = None,
     window_end: date | None = None,
+    actual_date: date | None = None,
+    status: str = "PLANNED",
 ) -> Visit:
     visit = Visit(
         study_id=study_id,
         subject_id=subject.id,
         visit_code=visit_code,
         planned_date=planned_date,
-        actual_date=None,
-        status="PLANNED",
+        actual_date=actual_date,
+        status=status,
         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,
@@ -39,8 +89,13 @@ async def create_visit(
 
 
 async def list_visits(db: AsyncSession, subject_id: uuid.UUID) -> Sequence[Visit]:
-    result = await db.execute(select(Visit).where(Visit.subject_id == subject_id).order_by(Visit.planned_date))
-    return result.scalars().all()
+    result = await db.execute(select(Visit).where(Visit.subject_id == subject_id))
+    visits = result.scalars().all()
+    if not visits:
+        return []
+    study_result = await db.execute(select(Study.visit_schedule).where(Study.id == visits[0].study_id))
+    visit_schedule = study_result.scalar_one_or_none() or []
+    return sort_visits_for_display(visits, visit_schedule)
 
 
 async def mark_overdue_as_lost(db: AsyncSession, subject_id: uuid.UUID) -> None:
@@ -150,32 +205,50 @@ async def list_lost_visits(
     return result.all()
 
 
-async def create_followup_visits(
+async def create_scheduled_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,
+    base_date: date | None,
+    visit_schedule: list[dict] | None,
 ) -> Sequence[Visit]:
-    if not visit_total or not visit_interval_days or visit_total < 2:
+    if not visit_schedule:
         return []
 
-    result = await db.execute(select(Visit.visit_code).where(Visit.subject_id == subject.id))
-    existing_codes = {row[0] for row in result.all()}
+    result = await db.execute(select(Visit).where(Visit.subject_id == subject.id))
+    existing_by_code = {visit.visit_code: visit for visit in result.scalars().all()}
     created: list[Visit] = []
-    for index in range(2, visit_total + 1):
-        code = f"V{index}"
-        if code in existing_codes:
+    for item in build_visit_schedule_dates(visit_schedule, base_date):
+        code = item["visit_code"]
+        is_baseline_visit = item["baseline_offset_days"] == 0 and base_date is not None
+        existing = existing_by_code.get(code)
+        if existing:
+            if is_baseline_visit:
+                await db.execute(
+                    sa_update(Visit)
+                    .where(Visit.id == existing.id)
+                    .values(
+                        planned_date=item["planned_date"],
+                        window_start=item["window_start"],
+                        window_end=item["window_end"],
+                        actual_date=base_date,
+                        status="DONE",
+                    )
+                )
+                await db.commit()
+            elif existing.status == "PLANNED" and existing.actual_date is None:
+                await db.execute(
+                    sa_update(Visit)
+                    .where(Visit.id == existing.id)
+                    .values(
+                        planned_date=item["planned_date"],
+                        window_start=item["window_start"],
+                        window_end=item["window_end"],
+                    )
+                )
+                await db.commit()
             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,
@@ -183,9 +256,11 @@ async def create_followup_visits(
                 visit_in=None,
                 subject=subject,
                 visit_code=code,
-                planned_date=planned_date,
-                window_start=window_start,
-                window_end=window_end,
+                planned_date=item["planned_date"],
+                window_start=item["window_start"],
+                window_end=item["window_end"],
+                actual_date=base_date if is_baseline_visit else None,
+                status="DONE" if is_baseline_visit else "PLANNED",
             )
         )
     return created

backend/app/main.py

@@ -12,6 +12,7 @@ from sqlalchemy import text
 from app.api.v1.router import api_router
 from app.core.config import settings
 from app.core.exceptions import register_exception_handlers
+from app.core.login_crypto import validate_login_crypto_configuration
 from app.crud.user import ensure_admin_exists
 from app.db.base import Base
 from app.db.session import SessionLocal, engine
@@ -76,6 +77,7 @@ async def _ensure_legacy_primary_keys(conn) -> None:
 
 
 def create_app() -> FastAPI:
+    validate_login_crypto_configuration()
     app = FastAPI(
         title="CTMS 后端 API",
         description="临床试验项目管理系统后端接口文档",

backend/app/models/study.py

@@ -1,7 +1,7 @@
 import uuid
 from datetime import date, datetime
 
-from sqlalchemy import Boolean, Date, DateTime, ForeignKey, Integer, String, Text, func
+from sqlalchemy import Boolean, Date, DateTime, ForeignKey, Integer, JSON, String, Text, func
 from sqlalchemy.dialects.postgresql import UUID
 from sqlalchemy.orm import Mapped, mapped_column
 
@@ -32,14 +32,9 @@ class Study(Base):
     planned_enrollment_count: Mapped[int | None] = mapped_column(Integer, nullable=True)
     enrollment_monthly_goal_note: Mapped[str | None] = mapped_column(Text, nullable=True)
     enrollment_stage_breakdown: Mapped[str | None] = mapped_column(Text, nullable=True)
-    summary_note: Mapped[str | None] = mapped_column(Text, nullable=True)
-    objective_note: Mapped[str | None] = mapped_column(Text, nullable=True)
     phase: Mapped[str | None] = mapped_column(String(50), nullable=True)
     status: Mapped[str] = mapped_column(String(20), nullable=False, default="DRAFT")
     is_locked: Mapped[bool] = mapped_column(Boolean, nullable=False, default=False)
-    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)
+    visit_schedule: Mapped[list[dict]] = mapped_column(JSON, nullable=False, default=list)
     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

@@ -20,6 +20,7 @@ class Subject(Base):
     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)
+    baseline_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)
     created_at: Mapped[datetime] = mapped_column(DateTime(timezone=True), nullable=False, server_default=func.now())

backend/app/schemas/study.py

@@ -2,12 +2,36 @@ import uuid
 from datetime import date, datetime
 from typing import Literal, Optional
 
-from pydantic import BaseModel, ConfigDict, Field
+from pydantic import BaseModel, ConfigDict, Field, model_validator
 
 StudyStatus = Literal["DRAFT", "ACTIVE", "CLOSED"]
 
 
-class StudyCreate(BaseModel):
+class VisitScheduleItem(BaseModel):
+    visit_code: str = Field(min_length=1, max_length=50)
+    baseline_offset_days: int = Field(ge=0, le=3650)
+    window_before_days: int = Field(ge=0, le=365)
+    window_after_days: int = Field(ge=0, le=365)
+
+
+class VisitScheduleMixin(BaseModel):
+    visit_schedule: list[VisitScheduleItem] = Field(default_factory=list)
+
+    @model_validator(mode="after")
+    def validate_visit_schedule(self):
+        codes: set[str] = set()
+        for index, item in enumerate(self.visit_schedule):
+            code = item.visit_code.strip()
+            if not code:
+                raise ValueError(f"第 {index + 1} 行访视编号不能为空")
+            if code in codes:
+                raise ValueError(f"访视编号重复：{code}")
+            codes.add(code)
+            item.visit_code = code
+        return self
+
+
+class StudyCreate(VisitScheduleMixin):
     name: str = Field(min_length=1)
     code: str = Field(min_length=1)
     project_full_name: Optional[str] = None
@@ -28,14 +52,8 @@ class StudyCreate(BaseModel):
     planned_enrollment_count: Optional[int] = None
     enrollment_monthly_goal_note: Optional[str] = None
     enrollment_stage_breakdown: Optional[str] = None
-    summary_note: Optional[str] = None
-    objective_note: 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):
@@ -59,15 +77,25 @@ class StudyUpdate(BaseModel):
     planned_enrollment_count: Optional[int] = None
     enrollment_monthly_goal_note: Optional[str] = None
     enrollment_stage_breakdown: Optional[str] = None
-    summary_note: Optional[str] = None
-    objective_note: Optional[str] = None
     phase: Optional[str] = None
     status: Optional[StudyStatus] = None
     is_locked: Optional[bool] = 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
+    visit_schedule: Optional[list[VisitScheduleItem]] = None
+
+    @model_validator(mode="after")
+    def validate_visit_schedule(self):
+        if self.visit_schedule is None:
+            return self
+        codes: set[str] = set()
+        for index, item in enumerate(self.visit_schedule):
+            code = item.visit_code.strip()
+            if not code:
+                raise ValueError(f"第 {index + 1} 行访视编号不能为空")
+            if code in codes:
+                raise ValueError(f"访视编号重复：{code}")
+            codes.add(code)
+            item.visit_code = code
+        return self
 
 
 class StudyRead(BaseModel):
@@ -92,15 +120,10 @@ class StudyRead(BaseModel):
     planned_enrollment_count: Optional[int]
     enrollment_monthly_goal_note: Optional[str]
     enrollment_stage_breakdown: Optional[str]
-    summary_note: Optional[str]
-    objective_note: Optional[str]
     phase: Optional[str]
     status: StudyStatus
     is_locked: bool
-    visit_interval_days: Optional[int]
-    visit_total: Optional[int]
-    visit_window_start_offset: Optional[int]
-    visit_window_end_offset: Optional[int]
+    visit_schedule: list[VisitScheduleItem]
     created_by: Optional[uuid.UUID]
     created_at: datetime
 

backend/app/schemas/study_setup_config.py

@@ -2,7 +2,7 @@ import uuid
 from datetime import datetime
 from typing import Literal
 
-from pydantic import BaseModel, ConfigDict, Field
+from pydantic import BaseModel, ConfigDict, Field, model_validator
 
 
 ConfirmStatus = Literal["待确认", "已确认", "退回"]
@@ -143,6 +143,13 @@ class SetupProjectionSummary(BaseModel):
     skipped_items: list[SetupProjectionSkippedItem] = Field(default_factory=list)
 
 
+class VisitScheduleItem(BaseModel):
+    visit_code: str = Field(min_length=1, max_length=50)
+    baseline_offset_days: int = Field(ge=0, le=3650)
+    window_before_days: int = Field(ge=0, le=365)
+    window_after_days: int = Field(ge=0, le=365)
+
+
 class ProjectPublishSnapshot(BaseModel):
     code: str = ""
     name: str = ""
@@ -162,13 +169,21 @@ class ProjectPublishSnapshot(BaseModel):
     plan_end_date: str = ""
     planned_site_count: int | None = None
     planned_enrollment_count: int | None = None
-    summary_note: str = ""
-    objective_note: str = ""
     status: str = ""
-    visit_interval_days: int | None = None
-    visit_total: int | None = None
-    visit_window_start_offset: int | None = None
-    visit_window_end_offset: int | None = None
+    visit_schedule: list[VisitScheduleItem] = Field(default_factory=list)
+
+    @model_validator(mode="after")
+    def validate_visit_schedule(self):
+        codes: set[str] = set()
+        for index, item in enumerate(self.visit_schedule):
+            code = item.visit_code.strip()
+            if not code:
+                raise ValueError(f"第 {index + 1} 行访视编号不能为空")
+            if code in codes:
+                raise ValueError(f"访视编号重复：{code}")
+            codes.add(code)
+            item.visit_code = code
+        return self
 
 
 class StudySetupConfigRead(BaseModel):

backend/app/schemas/subject.py

@@ -10,12 +10,15 @@ class SubjectCreate(BaseModel):
     subject_no: str
     screening_date: Optional[date] = None
     consent_date: Optional[date] = None
+    enrollment_date: Optional[date] = None
+    baseline_date: Optional[date] = None
 
 
 class SubjectUpdate(BaseModel):
     status: Optional[str] = None
     consent_date: Optional[date] = None
     enrollment_date: Optional[date] = None
+    baseline_date: Optional[date] = None
     completion_date: Optional[date] = None
     drop_reason: Optional[str] = None
 
@@ -29,6 +32,7 @@ class SubjectRead(BaseModel):
     screening_date: Optional[date]
     consent_date: Optional[date]
     enrollment_date: Optional[date]
+    baseline_date: Optional[date]
     completion_date: Optional[date]
     drop_reason: Optional[str]
     created_at: datetime

backend/app/schemas/user.py

@@ -23,7 +23,7 @@ class UserDisplay(BaseModel):
 
 
 class _PasswordValidator(BaseModel):
-    password: Optional[str] = Field(default=None, min_length=8)
+    password: Optional[str] = Field(default=None, min_length=8, max_length=72)
 
     @field_validator("password")
     @classmethod
@@ -36,7 +36,7 @@ class _PasswordValidator(BaseModel):
 
 
 class UserRegisterRequest(_PasswordValidator):
-    password: str = Field(min_length=8)
+    password: str = Field(min_length=8, max_length=72)
     email: EmailStr
     full_name: str = Field(min_length=1)
     role: RegisterRole
@@ -44,7 +44,7 @@ class UserRegisterRequest(_PasswordValidator):
 
 
 class UserCreate(_PasswordValidator):
-    password: str = Field(min_length=8)
+    password: str = Field(min_length=8, max_length=72)
     email: EmailStr
     full_name: str = Field(min_length=1)
     role: UserRole

backend/requirements.txt

@@ -2,6 +2,7 @@ fastapi==0.104.1
 uvicorn[standard]==0.24.0.post1
 sqlalchemy==2.0.23
 asyncpg==0.29.0
+aiosqlite==0.20.0
 pydantic-settings==2.1.0
 python-jose[cryptography]==3.3.0
 passlib[bcrypt]==1.7.4

backend/scripts/smoke_setup_config.py

@@ -1,4 +1,5 @@
 import asyncio
+import base64
 import json
 import os
 import sys
@@ -6,6 +7,9 @@ import urllib.error
 import urllib.request
 
 import asyncpg
+from cryptography.hazmat.primitives import hashes, serialization
+from cryptography.hazmat.primitives.asymmetric import padding
+from cryptography.hazmat.primitives.ciphers.aead import AESGCM
 
 
 BASE = os.getenv("BASE_URL", "http://localhost:8000")
@@ -66,13 +70,53 @@ def db_fetch(sql: str, *args) -> list[dict]:
     return asyncio.run(_db_fetch(sql, *args))
 
 
-def main() -> int:
-    print(f"[config] BASE={BASE} EMAIL={ADMIN_EMAIL}")
-    status, login = request_json(
+def encrypted_login(email: str, password: str) -> tuple[int, dict]:
+    status, login_key = request_json("/api/v1/auth/login-key")
+    if status != 200:
+        return status, login_key
+    public_key = serialization.load_pem_public_key(login_key["public_key"].encode("utf-8"))
+    plaintext = json.dumps(
+        {
+            "email": email,
+            "password": password,
+            "challenge": login_key["challenge"],
+        },
+        separators=(",", ":"),
+    ).encode("utf-8")
+    aes_key = AESGCM.generate_key(bit_length=256)
+    iv = os.urandom(12)
+    encrypted_data = AESGCM(aes_key).encrypt(iv, plaintext, None)
+    encrypted_key = public_key.encrypt(
+        aes_key,
+        padding.OAEP(
+            mgf=padding.MGF1(algorithm=hashes.SHA256()),
+            algorithm=hashes.SHA256(),
+            label=None,
+        ),
+    )
+    return request_json(
         "/api/v1/auth/login",
         method="POST",
-        payload={"email": ADMIN_EMAIL, "password": ADMIN_PASSWORD},
+        payload={
+            "key_id": login_key["key_id"],
+            "challenge": login_key["challenge"],
+            "ciphertext": base64.b64encode(
+                json.dumps(
+                    {
+                        "encrypted_key": base64.b64encode(encrypted_key).decode("ascii"),
+                        "iv": base64.b64encode(iv).decode("ascii"),
+                        "data": base64.b64encode(encrypted_data).decode("ascii"),
+                    },
+                    separators=(",", ":"),
+                ).encode("utf-8")
+            ).decode("ascii"),
+        },
     )
+
+
+def main() -> int:
+    print(f"[config] BASE={BASE} EMAIL={ADMIN_EMAIL}")
+    status, login = encrypted_login(ADMIN_EMAIL, ADMIN_PASSWORD)
     assert_or_exit(status == 200, f"登录失败 status={status} body={login}")
     token = login["access_token"]
 

backend/tests/test_login_crypto.py

@@ -0,0 +1,39 @@
+import pytest
+
+from app.core import login_crypto
+from app.core.config import settings
+from app.main import create_app
+
+
+def reset_login_crypto_state():
+    login_crypto._private_key = None
+    login_crypto._public_key_pem = None
+    login_crypto._challenges.clear()
+
+
+def test_production_requires_configured_login_private_key(monkeypatch):
+    reset_login_crypto_state()
+    monkeypatch.setattr(settings, "ENV", "production")
+    monkeypatch.setattr(settings, "LOGIN_RSA_PRIVATE_KEY", None)
+
+    with pytest.raises(ValueError, match="生产环境必须配置 LOGIN_RSA_PRIVATE_KEY"):
+        create_app()
+
+    reset_login_crypto_state()
+
+
+def test_login_challenge_cache_has_max_active_limit(monkeypatch):
+    reset_login_crypto_state()
+    monkeypatch.setattr(settings, "ENV", "test")
+    monkeypatch.setattr(settings, "LOGIN_CHALLENGE_MAX_ACTIVE", 2)
+
+    first = login_crypto.create_login_challenge()
+    second = login_crypto.create_login_challenge()
+    third = login_crypto.create_login_challenge()
+
+    assert len(login_crypto._challenges) == 2
+    assert not login_crypto.consume_login_challenge(first.value)
+    assert login_crypto.consume_login_challenge(second.value)
+    assert login_crypto.consume_login_challenge(third.value)
+
+    reset_login_crypto_state()

backend/tests/test_registration.py

@@ -1,7 +1,15 @@
 import pytest
 import pytest_asyncio
+from cryptography.hazmat.primitives.ciphers.aead import AESGCM
+from cryptography.hazmat.primitives import hashes, serialization
+from cryptography.hazmat.primitives.asymmetric import padding
 from httpx import AsyncClient
+from sqlalchemy.dialects.postgresql import UUID
 from sqlalchemy.ext.asyncio import async_sessionmaker, create_async_engine
+from sqlalchemy.ext.compiler import compiles
+import base64
+import json
+import os
 
 from app.main import create_app
 from app.core.deps import get_db_session
@@ -12,6 +20,55 @@ from app.models.user import User, UserRole, UserStatus
 TEST_DATABASE_URL = "sqlite+aiosqlite:///:memory:"
 
 
+@compiles(UUID, "sqlite")
+def compile_uuid_for_sqlite(_type, _compiler, **_kw):
+    return "CHAR(32)"
+
+
+async def encrypted_auth_payload(client: AsyncClient, email: str, password: str) -> dict:
+    key_resp = await client.get("/api/v1/auth/login-key")
+    assert key_resp.status_code == 200
+    login_key = key_resp.json()
+    public_key = serialization.load_pem_public_key(login_key["public_key"].encode("utf-8"))
+    plaintext = json.dumps(
+        {
+            "email": email,
+            "password": password,
+            "challenge": login_key["challenge"],
+        },
+        separators=(",", ":"),
+    ).encode("utf-8")
+    aes_key = AESGCM.generate_key(bit_length=256)
+    iv = os.urandom(12)
+    encrypted_data = AESGCM(aes_key).encrypt(iv, plaintext, None)
+    encrypted_key = public_key.encrypt(
+        aes_key,
+        padding.OAEP(
+            mgf=padding.MGF1(algorithm=hashes.SHA256()),
+            algorithm=hashes.SHA256(),
+            label=None,
+        ),
+    )
+    return {
+        "key_id": login_key["key_id"],
+        "challenge": login_key["challenge"],
+        "ciphertext": base64.b64encode(
+            json.dumps(
+                {
+                    "encrypted_key": base64.b64encode(encrypted_key).decode("ascii"),
+                    "iv": base64.b64encode(iv).decode("ascii"),
+                    "data": base64.b64encode(encrypted_data).decode("ascii"),
+                },
+                separators=(",", ":"),
+            ).encode("utf-8")
+        ).decode("ascii"),
+    }
+
+
+async def encrypted_login(client: AsyncClient, email: str, password: str):
+    return await client.post("/api/v1/auth/login", json=await encrypted_auth_payload(client, email, password))
+
+
 @pytest_asyncio.fixture
 async def client_and_db():
     engine = create_async_engine(TEST_DATABASE_URL, future=True)
@@ -87,7 +144,7 @@ async def test_login_blocked_before_approval(client_and_db):
         "department": "Safety",
     }
     await client.post("/api/v1/auth/register", json=payload)
-    resp = await client.post("/api/v1/auth/login", json={"email": payload["email"], "password": payload["password"]})
+    resp = await encrypted_login(client, payload["email"], payload["password"])
     assert resp.status_code == 401
     assert "账号未审核" in resp.json().get("detail", "")
 
@@ -107,7 +164,7 @@ async def test_admin_can_approve_user(client_and_db):
         user = await user_crud.get_by_email(session, payload["email"])
         user_id = user.id
 
-    admin_login = await client.post("/api/v1/auth/login", json={"email": "admin@test.com", "password": "admin123"})
+    admin_login = await encrypted_login(client, "admin@test.com", "admin123")
     token = admin_login.json()["access_token"]
     headers = {"Authorization": f"Bearer {token}"}
 
@@ -131,3 +188,71 @@ async def test_admin_role_cannot_register(client_and_db):
     }
     resp = await client.post("/api/v1/auth/register", json=payload)
     assert resp.status_code in (400, 422)
+
+
+@pytest.mark.asyncio
+async def test_plaintext_login_is_rejected(client_and_db):
+    client, _ = client_and_db
+    resp = await client.post("/api/v1/auth/login", json={"email": "admin@test.com", "password": "admin123"})
+    assert resp.status_code == 422
+
+
+@pytest.mark.asyncio
+async def test_login_challenge_cannot_be_reused(client_and_db):
+    client, _ = client_and_db
+    key_resp = await client.get("/api/v1/auth/login-key")
+    login_key = key_resp.json()
+    public_key = serialization.load_pem_public_key(login_key["public_key"].encode("utf-8"))
+    plaintext = json.dumps(
+        {
+            "email": "admin@test.com",
+            "password": "admin123",
+            "challenge": login_key["challenge"],
+        },
+        separators=(",", ":"),
+    ).encode("utf-8")
+    aes_key = AESGCM.generate_key(bit_length=256)
+    iv = os.urandom(12)
+    encrypted_data = AESGCM(aes_key).encrypt(iv, plaintext, None)
+    encrypted_key = public_key.encrypt(
+        aes_key,
+        padding.OAEP(
+            mgf=padding.MGF1(algorithm=hashes.SHA256()),
+            algorithm=hashes.SHA256(),
+            label=None,
+        )
+    )
+    ciphertext = base64.b64encode(
+        json.dumps(
+            {
+                "encrypted_key": base64.b64encode(encrypted_key).decode("ascii"),
+                "iv": base64.b64encode(iv).decode("ascii"),
+                "data": base64.b64encode(encrypted_data).decode("ascii"),
+            },
+            separators=(",", ":"),
+        ).encode("utf-8")
+    ).decode("ascii")
+    payload = {
+        "key_id": login_key["key_id"],
+        "challenge": login_key["challenge"],
+        "ciphertext": ciphertext,
+    }
+
+    first = await client.post("/api/v1/auth/login", json=payload)
+    second = await client.post("/api/v1/auth/login", json=payload)
+
+    assert first.status_code == 200
+    assert second.status_code == 401
+
+
+@pytest.mark.asyncio
+async def test_unlock_requires_encrypted_password(client_and_db):
+    client, _ = client_and_db
+    plaintext = await client.post("/api/v1/auth/unlock", json={"email": "admin@test.com", "password": "admin123"})
+    encrypted = await client.post(
+        "/api/v1/auth/unlock",
+        json=await encrypted_auth_payload(client, "admin@test.com", "admin123"),
+    )
+
+    assert plaintext.status_code == 422
+    assert encrypted.status_code == 200

backend/tests/test_visit_schedule.py

@@ -0,0 +1,144 @@
+from datetime import date
+from types import SimpleNamespace
+
+from app.crud.subject import should_generate_visits_after_subject_update
+from app.crud.visit import build_visit_schedule_dates, sort_visits_for_display
+from app.schemas.study import StudyUpdate
+
+
+def test_build_visit_schedule_dates_uses_per_visit_windows():
+    baseline_date = date(2026, 5, 8)
+
+    visits = build_visit_schedule_dates(
+        [
+            {
+                "visit_code": "基线访视",
+                "baseline_offset_days": 0,
+                "window_before_days": 0,
+                "window_after_days": 0,
+            },
+            {
+                "visit_code": "V1",
+                "baseline_offset_days": 7,
+                "window_before_days": 2,
+                "window_after_days": 2,
+            },
+            {
+                "visit_code": "V2",
+                "baseline_offset_days": 15,
+                "window_before_days": 2,
+                "window_after_days": 2,
+            },
+            {
+                "visit_code": "V3",
+                "baseline_offset_days": 23,
+                "window_before_days": 3,
+                "window_after_days": 3,
+            },
+        ],
+        baseline_date,
+    )
+
+    assert [
+        (visit["visit_code"], visit["baseline_offset_days"], visit["planned_date"], visit["window_start"], visit["window_end"])
+        for visit in visits
+    ] == [
+        ("基线访视", 0, date(2026, 5, 8), date(2026, 5, 8), date(2026, 5, 8)),
+        ("V1", 7, date(2026, 5, 15), date(2026, 5, 13), date(2026, 5, 17)),
+        ("V2", 15, date(2026, 5, 23), date(2026, 5, 21), date(2026, 5, 25)),
+        ("V3", 23, date(2026, 5, 31), date(2026, 5, 28), date(2026, 6, 3)),
+    ]
+
+
+def test_build_visit_schedule_dates_keeps_visit_structure_without_baseline_date():
+    visits = build_visit_schedule_dates(
+        [
+            {
+                "visit_code": "基线访视",
+                "baseline_offset_days": 0,
+                "window_before_days": 0,
+                "window_after_days": 0,
+            },
+            {
+                "visit_code": "V1",
+                "baseline_offset_days": 7,
+                "window_before_days": 2,
+                "window_after_days": 2,
+            },
+        ],
+        None,
+    )
+
+    assert [
+        (visit["visit_code"], visit["planned_date"], visit["window_start"], visit["window_end"])
+        for visit in visits
+    ] == [
+        ("基线访视", None, None, None),
+        ("V1", None, None, None),
+    ]
+
+
+def test_study_update_allows_multiple_visits_with_same_baseline_offset():
+    payload = StudyUpdate(
+        visit_schedule=[
+            {
+                "visit_code": "筛选访视",
+                "baseline_offset_days": 0,
+                "window_before_days": 0,
+                "window_after_days": 0,
+            },
+            {
+                "visit_code": "基线访视",
+                "baseline_offset_days": 0,
+                "window_before_days": 0,
+                "window_after_days": 0,
+            },
+        ]
+    )
+
+    assert [item.visit_code for item in payload.visit_schedule or []] == ["筛选访视", "基线访视"]
+
+
+def test_sort_visits_for_display_follows_configured_visit_order_without_dates():
+    visits = [
+        SimpleNamespace(visit_code="V1", planned_date=None),
+        SimpleNamespace(visit_code="V2", planned_date=None),
+        SimpleNamespace(visit_code="基线访视", planned_date=None),
+    ]
+    visit_schedule = [
+        {"visit_code": "基线访视"},
+        {"visit_code": "V1"},
+        {"visit_code": "V2"},
+    ]
+
+    assert [visit.visit_code for visit in sort_visits_for_display(visits, visit_schedule)] == ["基线访视", "V1", "V2"]
+
+
+def test_sort_visits_for_display_does_not_infer_business_order():
+    visits = [
+        SimpleNamespace(visit_code="基线访视", planned_date=None),
+        SimpleNamespace(visit_code="V1", planned_date=None),
+        SimpleNamespace(visit_code="V2", planned_date=None),
+    ]
+    visit_schedule = [
+        {"visit_code": "V1"},
+        {"visit_code": "V2"},
+        {"visit_code": "基线访视"},
+    ]
+
+    assert [visit.visit_code for visit in sort_visits_for_display(visits, visit_schedule)] == ["V1", "V2", "基线访视"]
+
+
+def test_should_generate_visits_when_baseline_date_is_set_or_changed():
+    assert should_generate_visits_after_subject_update(
+        previous_baseline_date=None,
+        next_baseline_date=date(2026, 5, 8),
+    )
+    assert should_generate_visits_after_subject_update(
+        previous_baseline_date=date(2026, 5, 8),
+        next_baseline_date=date(2026, 5, 9),
+    )
+    assert not should_generate_visits_after_subject_update(
+        previous_baseline_date=None,
+        next_baseline_date=None,
+    )

database/init.sql

@@ -46,10 +46,7 @@ CREATE TABLE IF NOT EXISTS public.studies (
     phase character varying(50),
     status character varying(20) NOT NULL DEFAULT 'DRAFT',
     is_locked boolean NOT NULL DEFAULT false,
-    visit_interval_days integer,
-    visit_total integer,
-    visit_window_start_offset integer,
-    visit_window_end_offset integer,
+    visit_schedule jsonb NOT NULL DEFAULT '[]'::jsonb,
     created_by uuid,
     created_at timestamp with time zone NOT NULL DEFAULT now(),
     CONSTRAINT uq_studies_code UNIQUE (code),
@@ -112,6 +109,7 @@ CREATE TABLE IF NOT EXISTS public.subjects (
     screening_date date,
     consent_date date,
     enrollment_date date,
+    baseline_date date,
     completion_date date,
     drop_reason text,
     created_at timestamp with time zone NOT NULL DEFAULT now(),
@@ -591,7 +589,7 @@ ON CONFLICT (email) DO UPDATE SET
     updated_at = EXCLUDED.updated_at;
 
 INSERT INTO public.studies (
-    id, code, name, sponsor, protocol_no, phase, status, visit_interval_days, visit_total, visit_window_start_offset, visit_window_end_offset, created_by, created_at
+    id, code, name, sponsor, protocol_no, phase, status, visit_schedule, created_by, created_at
 ) VALUES (
     'aaaaaaaa-aaaa-aaaa-aaaa-aaaaaaaaaaaa',
     'DEMO-CTMS',
@@ -600,10 +598,12 @@ INSERT INTO public.studies (
     'DP-001',
     'Phase II',
     'ACTIVE',
-    7,
-    3,
-    -2,
-    2,
+    '[
+        {"visit_code": "基线访视", "baseline_offset_days": 0, "window_before_days": 0, "window_after_days": 0},
+        {"visit_code": "V1", "baseline_offset_days": 7, "window_before_days": 2, "window_after_days": 2},
+        {"visit_code": "V2", "baseline_offset_days": 15, "window_before_days": 2, "window_after_days": 2},
+        {"visit_code": "V3", "baseline_offset_days": 23, "window_before_days": 3, "window_after_days": 3}
+    ]'::jsonb,
     (SELECT id FROM public.users WHERE email = 'admin@example.com'),
     '2025-01-06 08:00:00+00'
 ) ON CONFLICT (code) DO UPDATE SET
@@ -612,10 +612,7 @@ INSERT INTO public.studies (
     protocol_no = EXCLUDED.protocol_no,
     phase = EXCLUDED.phase,
     status = EXCLUDED.status,
-    visit_interval_days = EXCLUDED.visit_interval_days,
-    visit_total = EXCLUDED.visit_total,
-    visit_window_start_offset = EXCLUDED.visit_window_start_offset,
-    visit_window_end_offset = EXCLUDED.visit_window_end_offset,
+    visit_schedule = EXCLUDED.visit_schedule,
     created_by = EXCLUDED.created_by;
 
 INSERT INTO public.sites (
@@ -753,17 +750,18 @@ INSERT INTO public.training_authorizations (
 ON CONFLICT (id) DO NOTHING;
 
 INSERT INTO public.subjects (
-    id, study_id, site_id, subject_no, status, screening_date, consent_date, enrollment_date, completion_date, drop_reason, created_at, updated_at
+    id, study_id, site_id, subject_no, status, screening_date, consent_date, enrollment_date, baseline_date, completion_date, drop_reason, created_at, updated_at
 ) VALUES
-    ('11111111-2222-3333-4444-555555555555', (SELECT id FROM public.studies WHERE code = 'DEMO-CTMS'), 'bbbbbbbb-bbbb-bbbb-bbbb-bbbbbbbbbbbb', 'SUBJ-001', 'ENROLLED', '2025-01-05', '2025-01-06', '2025-01-10', NULL, NULL, '2025-01-10 10:00:00+00', '2025-01-10 10:00:00+00'),
-    ('22222222-3333-4444-5555-666666666666', (SELECT id FROM public.studies WHERE code = 'DEMO-CTMS'), 'cccccccc-cccc-cccc-cccc-cccccccccccc', 'SUBJ-002', 'SCREENING', '2025-01-12', '2025-01-13', NULL, NULL, NULL, '2025-01-12 10:00:00+00', '2025-01-12 10:00:00+00'),
-    ('33333333-4444-5555-6666-777777777777', (SELECT id FROM public.studies WHERE code = 'DEMO-CTMS'), 'bbbbbbbb-bbbb-bbbb-bbbb-bbbbbbbbbbbb', 'SUBJ-003', 'COMPLETED', '2024-12-20', '2024-12-21', '2024-12-28', '2025-02-05', NULL, '2025-02-05 10:00:00+00', '2025-02-05 10:00:00+00')
+    ('11111111-2222-3333-4444-555555555555', (SELECT id FROM public.studies WHERE code = 'DEMO-CTMS'), 'bbbbbbbb-bbbb-bbbb-bbbb-bbbbbbbbbbbb', 'SUBJ-001', 'ENROLLED', '2025-01-05', '2025-01-06', '2025-01-10', '2025-01-10', NULL, NULL, '2025-01-10 10:00:00+00', '2025-01-10 10:00:00+00'),
+    ('22222222-3333-4444-5555-666666666666', (SELECT id FROM public.studies WHERE code = 'DEMO-CTMS'), 'cccccccc-cccc-cccc-cccc-cccccccccccc', 'SUBJ-002', 'SCREENING', '2025-01-12', '2025-01-13', NULL, NULL, NULL, NULL, '2025-01-12 10:00:00+00', '2025-01-12 10:00:00+00'),
+    ('33333333-4444-5555-6666-777777777777', (SELECT id FROM public.studies WHERE code = 'DEMO-CTMS'), 'bbbbbbbb-bbbb-bbbb-bbbb-bbbbbbbbbbbb', 'SUBJ-003', 'COMPLETED', '2024-12-20', '2024-12-21', '2024-12-28', '2024-12-28', '2025-02-05', NULL, '2025-02-05 10:00:00+00', '2025-02-05 10:00:00+00')
 ON CONFLICT (study_id, subject_no) DO UPDATE SET
     site_id = EXCLUDED.site_id,
     status = EXCLUDED.status,
     screening_date = EXCLUDED.screening_date,
     consent_date = EXCLUDED.consent_date,
     enrollment_date = EXCLUDED.enrollment_date,
+    baseline_date = EXCLUDED.baseline_date,
     completion_date = EXCLUDED.completion_date,
     drop_reason = EXCLUDED.drop_reason,
     updated_at = EXCLUDED.updated_at;

docker-compose.yaml

@@ -30,6 +30,10 @@ services:
       - "8000:8000"
     environment:
       DATABASE_URL: postgresql+asyncpg://ctms_user:secret_password@db/ctms_db
+      ENV: ${ENV:-development}
+      JWT_SECRET_KEY: ${JWT_SECRET_KEY:-dev-secret}
+      LOGIN_RSA_PRIVATE_KEY: ${LOGIN_RSA_PRIVATE_KEY:-}
+      LOGIN_RSA_KEY_ID: ${LOGIN_RSA_KEY_ID:-default}
     depends_on:
       db:
         condition: service_healthy
@@ -43,6 +47,10 @@ services:
     command: python scripts/init_production.py
     environment:
       DATABASE_URL: postgresql+asyncpg://ctms_user:secret_password@db/ctms_db
+      ENV: ${ENV:-development}
+      JWT_SECRET_KEY: ${JWT_SECRET_KEY:-dev-secret}
+      LOGIN_RSA_PRIVATE_KEY: ${LOGIN_RSA_PRIVATE_KEY:-}
+      LOGIN_RSA_KEY_ID: ${LOGIN_RSA_KEY_ID:-default}
     depends_on:
       db:
         condition: service_healthy

docs/README.md

@@ -5,6 +5,7 @@ CTMS 文档按用途分为三类：当前操作手册、审计与治理记录、
 ## 当前常用
 
 - [`guides/release-checklist.md`](guides/release-checklist.md): 发布前检查项与回归门禁
+- [`guides/branch-environment-installation.md`](guides/branch-environment-installation.md): `dev`、`main`、`release` 分支环境安装配置
 - [`guides/setup-config-api.md`](guides/setup-config-api.md): 立项配置接口、联调与冒烟说明
 - [`setup-config-curl-smoke.sh`](setup-config-curl-smoke.sh): 立项配置 curl 冒烟脚本
 - [`postman/setup-config.postman_collection.json`](postman/setup-config.postman_collection.json): Postman 联调集合

docs/guides/branch-environment-installation.md

@@ -0,0 +1,328 @@
+# CTMS 分支环境安装配置指南
+
+本文定义 `dev`、`main`、`release` 三类分支对应的推荐部署环境、配置文件、初始化步骤与验证命令。分支本身不会自动切换运行模式，实际模式由后端环境变量 `ENV` 决定。
+
+## 分支与环境映射
+
+| 分支 | 分支定位 | 推荐环境 | 后端 `ENV` | 用途 |
+| --- | --- | --- | --- | --- |
+| `dev` | 日常开发与集成 | 开发环境 | `development` | 功能开发、联调、自测、内部集成 |
+| `main` | 下一版本候选 | 预发布 / 验收环境 | `production` | 回归测试、验收、发布候选验证 |
+| `release` | 当前稳定生产线 | 生产环境 | `production` | 正式生产部署、生产 hotfix |
+
+推广路径保持为：
+
+```text
+feature/* -> dev -> main -> release
+```
+
+不要把 `release` 当作日常开发分支使用。`main` 应只接收已经准备进入候选版本范围的变更。
+
+## 公共前置条件
+
+所有环境都需要：
+
+- Docker 与 Docker Compose
+- 可写的 `pg_data/` 数据目录
+- 端口 `8888`、`8000`、`5432` 未被占用
+- 后端镜像可安装 `backend/requirements.txt` 中的依赖
+- 前端镜像可执行 `npm ci` 与 `npm run build`
+
+当前 compose 服务拓扑：
+
+```text
+nginx -> backend -> db
+```
+
+对外入口：
+
+- 前端：`http://localhost:8888`
+- 后端 API：同域 `/api/v1/*`
+- 健康检查：`http://localhost:8888/health`
+
+## dev 分支：开发环境
+
+`dev` 默认用于本地开发和内部集成，推荐使用 `ENV=development`。
+
+### 1. 切换分支
+
+```bash
+git checkout dev
+git pull --rebase origin dev
+```
+
+### 2. 配置 `.env`
+
+根目录 `.env` 不提交到仓库。开发环境推荐：
+
+```env
+COMPOSE_PROJECT_NAME=ctms_dev
+ENV=development
+JWT_SECRET_KEY=dev-secret
+LOGIN_RSA_KEY_ID=default
+LOGIN_RSA_PRIVATE_KEY=
+```
+
+说明：
+
+- `ENV=development` 会启用开发行为。
+- 未配置 `LOGIN_RSA_PRIVATE_KEY` 时，后端启动后会生成临时 RSA 私钥。
+- 后端重启后临时公钥会变化，已有登录页应刷新后重新登录。
+- `JWT_SECRET_KEY=dev-secret` 只允许本地开发使用。
+
+### 3. 启动
+
+```bash
+docker compose up -d --build backend nginx
+```
+
+如果需要首次启动完整栈：
+
+```bash
+docker compose up -d --build
+```
+
+### 4. 开发模式行为
+
+`development` 模式下：
+
+- FastAPI `debug=True`
+- 应用启动时会执行 `Base.metadata.create_all`
+- 应用启动时会确保默认管理员存在
+- 未配置 RSA 私钥时允许临时生成
+
+这些行为只适合开发，不适合生产。
+
+### 5. 验证
+
+```bash
+docker compose ps
+docker compose exec backend python -c "from app.core.config import settings; print(settings.ENV)"
+curl -i http://127.0.0.1:8888/health
+curl -i http://127.0.0.1:8888/api/v1/auth/login-key
+```
+
+预期：
+
+```text
+ENV=development
+GET /health -> 200
+GET /api/v1/auth/login-key -> 200, key_id=default
+```
+
+## main 分支：预发布 / 验收环境
+
+`main` 是下一正式版本候选分支，应按生产模式运行，但不直接承载正式生产流量。
+
+### 1. 切换分支
+
+```bash
+git checkout main
+git pull --rebase origin main
+```
+
+### 2. 配置 `.env`
+
+预发布环境应使用 `ENV=production`，并配置独立于生产的密钥：
+
+```env
+COMPOSE_PROJECT_NAME=ctms_staging
+ENV=production
+JWT_SECRET_KEY=<staging-strong-random-secret>
+LOGIN_RSA_KEY_ID=staging-YYYYMMDD
+LOGIN_RSA_PRIVATE_KEY=<staging-rsa-private-key-pem-with-\n-escaped-newlines>
+```
+
+生成密钥示例：
+
+```bash
+openssl rand -hex 32
+openssl genpkey -algorithm RSA -pkeyopt rsa_keygen_bits:2048
+```
+
+要求：
+
+- `JWT_SECRET_KEY` 不得使用 `dev-secret`。
+- `LOGIN_RSA_PRIVATE_KEY` 必须固定保存，不能每次部署重新生成。
+- staging 私钥不得复用 production 私钥。
+
+### 3. 初始化数据库
+
+生产模式不会自动建表或自动补管理员。首次部署或迁移前执行：
+
+```bash
+docker compose run --rm backend-init
+```
+
+该步骤应运行 Alembic migration，并确保固定管理员账号存在。
+
+### 4. 启动
+
+```bash
+docker compose up -d --build
+```
+
+### 5. 验证
+
+```bash
+docker compose config
+docker compose ps
+docker compose exec backend python -c "from app.core.config import settings; print(settings.ENV); print(settings.JWT_SECRET_KEY == 'dev-secret'); print(bool(settings.LOGIN_RSA_PRIVATE_KEY))"
+curl -i http://127.0.0.1:8888/health
+curl -i http://127.0.0.1:8888/api/v1/auth/login-key
+```
+
+预期：
+
+```text
+ENV=production
+JWT_SECRET_KEY == dev-secret -> False
+LOGIN_RSA_PRIVATE_KEY_SET -> True
+GET /health -> 200
+GET /api/v1/auth/login-key -> 200
+```
+
+### 6. 验收门禁
+
+在把 `main` 推进到 `release` 前，至少执行：
+
+```bash
+docker compose run --rm -v "$PWD/backend/tests:/code/tests:ro" backend python -m pytest
+cd frontend && npm run test:unit
+cd frontend && npm run type-check
+cd frontend && npm run build
+```
+
+## release 分支：生产环境
+
+`release` 是正式生产稳定分支。只有正式发布和生产 hotfix 应进入该分支。
+
+### 1. 切换分支
+
+```bash
+git checkout release
+git pull --rebase origin release
+```
+
+### 2. 配置 `.env`
+
+生产环境必须使用生产专用配置：
+
+```env
+COMPOSE_PROJECT_NAME=ctms_prod
+ENV=production
+JWT_SECRET_KEY=<production-strong-random-secret>
+LOGIN_RSA_KEY_ID=prod-YYYYMMDD
+LOGIN_RSA_PRIVATE_KEY=<production-rsa-private-key-pem-with-\n-escaped-newlines>
+```
+
+要求：
+
+- `.env` 必须只保存在部署机器或密钥管理系统中。
+- 不得提交 `.env`、私钥、JWT 密钥。
+- `JWT_SECRET_KEY` 轮换会使既有 token 失效，应安排维护窗口。
+- `LOGIN_RSA_PRIVATE_KEY` 轮换会影响新登录密钥获取，应同步更新 `LOGIN_RSA_KEY_ID`。
+
+### 3. HTTPS 要求
+
+登录加密依赖浏览器 WebCrypto。生产访问必须使用 HTTPS：
+
+- `https://正式域名`
+- 本地 `localhost` 是浏览器安全上下文例外，但不能代表生产可用性
+
+如果生产仍通过 `http://服务器IP:8888` 访问，前端会拒绝执行登录加密。
+
+### 4. 初始化与迁移
+
+首次部署或每次包含 migration 的发布：
+
+```bash
+docker compose run --rm backend-init
+```
+
+确认 migration 成功后再启动或滚动重启服务。
+
+### 5. 启动
+
+```bash
+docker compose up -d --build
+```
+
+### 6. 生产验证
+
+```bash
+docker compose ps
+docker compose exec backend python -c "from app.core.config import settings; print(settings.ENV); print(settings.JWT_SECRET_KEY == 'dev-secret'); print(bool(settings.LOGIN_RSA_PRIVATE_KEY)); print(settings.LOGIN_RSA_KEY_ID)"
+curl -i https://<production-domain>/health
+curl -i https://<production-domain>/api/v1/auth/login-key
+```
+
+预期：
+
+```text
+ENV=production
+JWT_SECRET_KEY == dev-secret -> False
+LOGIN_RSA_PRIVATE_KEY_SET -> True
+GET /health -> 200
+GET /api/v1/auth/login-key -> 200
+```
+
+### 7. 多实例约束
+
+当前登录 challenge 默认保存在后端进程内：
+
+- 单实例、单 worker：可直接使用
+- 多实例或多 worker：必须满足以下至少一项
+  - 使用共享缓存保存 challenge，例如 Redis
+  - 启用粘性会话，确保 `/login-key` 与 `/login` 命中同一后端进程
+  - 将后端限制为单 worker 单副本
+
+如果不满足，上线后可能出现偶发登录失败。
+
+## 环境变量说明
+
+| 变量 | dev | main/staging | release/production | 说明 |
+| --- | --- | --- | --- | --- |
+| `COMPOSE_PROJECT_NAME` | `ctms_dev` | `ctms_staging` | `ctms_prod` | 防止不同环境容器名、网络名冲突 |
+| `ENV` | `development` | `production` | `production` | 后端运行模式 |
+| `JWT_SECRET_KEY` | `dev-secret` | 强随机 | 强随机 | JWT 签名密钥 |
+| `LOGIN_RSA_KEY_ID` | `default` | `staging-YYYYMMDD` | `prod-YYYYMMDD` | 登录 RSA 密钥版本 |
+| `LOGIN_RSA_PRIVATE_KEY` | 空 | staging 私钥 | production 私钥 | RSA 私钥，生产模式必填 |
+
+## 常见问题
+
+### 登录页提示当前浏览器环境不支持安全登录加密
+
+原因：非 HTTPS、非 localhost 的访问环境不满足 WebCrypto 安全上下文要求。
+
+处理：
+
+- 本地使用 `http://localhost:8888`
+- staging/production 使用 HTTPS 域名
+
+### production 模式启动失败，提示必须配置 LOGIN_RSA_PRIVATE_KEY
+
+原因：`ENV=production` 时必须提供固定 RSA 私钥。
+
+处理：
+
+```bash
+openssl genpkey -algorithm RSA -pkeyopt rsa_keygen_bits:2048
+```
+
+将输出 PEM 写入 `.env` 的 `LOGIN_RSA_PRIVATE_KEY`，换行使用 `\n` 转义。
+
+### 切换分支后环境不符合预期
+
+分支不会自动修改 `.env`。切换分支后应重新确认：
+
+```bash
+docker compose config
+docker compose exec backend python -c "from app.core.config import settings; print(settings.ENV)"
+```
+
+必要时修改 `.env` 并重启：
+
+```bash
+docker compose up -d --build backend nginx
+```

docs/guides/setup-config-api.md

@@ -104,13 +104,21 @@
     "plan_end_date": "2026-12-31",
     "planned_site_count": 12,
     "planned_enrollment_count": 120,
-    "summary_note": "",
-    "objective_note": "",
     "status": "DRAFT",
-    "visit_interval_days": null,
-    "visit_total": null,
-    "visit_window_start_offset": null,
-    "visit_window_end_offset": null
+    "visit_schedule": [
+      {
+        "visit_code": "基线访视",
+        "baseline_offset_days": 0,
+        "window_before_days": 0,
+        "window_after_days": 0
+      },
+      {
+        "visit_code": "V1",
+        "baseline_offset_days": 7,
+        "window_before_days": 2,
+        "window_after_days": 2
+      }
+    ]
   },
   "saved_by": "11111111-1111-1111-1111-111111111111",
   "saved_by_name": "System Admin",

docs/postman/setup-config.postman_collection.json

@@ -6,7 +6,35 @@
   },
   "item": [
     {
-      "name": "1. 登录（获取 Token）",
+      "name": "1. 获取登录公钥",
+      "request": {
+        "method": "GET",
+        "header": [],
+        "url": {
+          "raw": "{{base_url}}/api/v1/auth/login-key",
+          "host": ["{{base_url}}"],
+          "path": ["api", "v1", "auth", "login-key"]
+        }
+      },
+      "event": [
+        {
+          "listen": "test",
+          "script": {
+            "type": "text/javascript",
+            "exec": [
+              "pm.test('status is 200', function () { pm.response.to.have.status(200); });",
+              "var json = pm.response.json();",
+              "pm.collectionVariables.set('login_key_id', json.key_id || '');",
+              "pm.collectionVariables.set('login_challenge', json.challenge || '');",
+              "pm.collectionVariables.set('login_public_key', json.public_key || '');",
+              "pm.collectionVariables.set('login_ciphertext', '<请生成 AES-GCM 密文，并用 login_public_key 通过 RSA-OAEP-SHA256 加密 AES key 后填写外层 Base64 envelope>');"
+            ]
+          }
+        }
+      ]
+    },
+    {
+      "name": "2. 加密登录（获取 Token）",
       "request": {
         "method": "POST",
         "header": [
@@ -14,7 +42,7 @@
         ],
         "body": {
           "mode": "raw",
-          "raw": "{\n  \"email\": \"{{email}}\",\n  \"password\": \"{{password}}\"\n}"
+          "raw": "{\n  \"key_id\": \"{{login_key_id}}\",\n  \"challenge\": \"{{login_challenge}}\",\n  \"ciphertext\": \"{{login_ciphertext}}\"\n}"
         },
         "url": {
           "raw": "{{base_url}}/api/v1/auth/login",

docs/setup-config-curl-smoke.sh

@@ -7,10 +7,65 @@ PASSWORD="${PASSWORD:-admin123}"
 STUDY_ID="${STUDY_ID:-aaaaaaaa-aaaa-aaaa-aaaa-aaaaaaaaaaaa}"
 
 echo "[1/6] login: $EMAIL"
-TOKEN=$(curl -sS -X POST "$BASE_URL/api/v1/auth/login" \
-  -H 'Content-Type: application/json' \
-  -d "{\"email\":\"$EMAIL\",\"password\":\"$PASSWORD\"}" | \
-  python3 -c 'import json,sys; print(json.load(sys.stdin).get("access_token",""))')
+TOKEN=$(BASE_URL="$BASE_URL" EMAIL="$EMAIL" PASSWORD="$PASSWORD" python3 - <<'PY'
+import base64
+import json
+import os
+import urllib.request
+
+from cryptography.hazmat.primitives import hashes, serialization
+from cryptography.hazmat.primitives.asymmetric import padding
+from cryptography.hazmat.primitives.ciphers.aead import AESGCM
+
+base_url = os.environ["BASE_URL"]
+email = os.environ["EMAIL"]
+password = os.environ["PASSWORD"]
+
+with urllib.request.urlopen(f"{base_url}/api/v1/auth/login-key", timeout=20) as resp:
+    login_key = json.loads(resp.read().decode())
+
+public_key = serialization.load_pem_public_key(login_key["public_key"].encode("utf-8"))
+plaintext = json.dumps(
+    {"email": email, "password": password, "challenge": login_key["challenge"]},
+    separators=(",", ":"),
+).encode("utf-8")
+aes_key = AESGCM.generate_key(bit_length=256)
+iv = os.urandom(12)
+encrypted_data = AESGCM(aes_key).encrypt(iv, plaintext, None)
+encrypted_key = public_key.encrypt(
+    aes_key,
+    padding.OAEP(
+        mgf=padding.MGF1(algorithm=hashes.SHA256()),
+        algorithm=hashes.SHA256(),
+        label=None,
+    ),
+)
+payload = json.dumps(
+    {
+        "key_id": login_key["key_id"],
+        "challenge": login_key["challenge"],
+        "ciphertext": base64.b64encode(
+            json.dumps(
+                {
+                    "encrypted_key": base64.b64encode(encrypted_key).decode("ascii"),
+                    "iv": base64.b64encode(iv).decode("ascii"),
+                    "data": base64.b64encode(encrypted_data).decode("ascii"),
+                },
+                separators=(",", ":"),
+            ).encode("utf-8")
+        ).decode("ascii"),
+    }
+).encode()
+req = urllib.request.Request(
+    f"{base_url}/api/v1/auth/login",
+    method="POST",
+    headers={"Content-Type": "application/json"},
+    data=payload,
+)
+with urllib.request.urlopen(req, timeout=20) as resp:
+    print(json.loads(resp.read().decode()).get("access_token", ""))
+PY
+)
 
 if [[ -z "$TOKEN" ]]; then
   echo "login failed: access_token empty"

frontend/src/api/auth.ts

@@ -1,10 +1,13 @@
 import type { AxiosResponse } from "axios";
 import api, { apiGet, apiPatch, apiPost } from "./axios";
-import type { UserMeResponse, LoginRequest, LoginResponse, RegisterRequest } from "../types/api";
+import type { UserMeResponse, LoginRequest, LoginResponse, LoginKeyResponse, RegisterRequest } from "../types/api";
 
 export const login = (payload: LoginRequest): Promise<AxiosResponse<LoginResponse>> =>
   apiPost<LoginResponse>("/api/v1/auth/login", payload);
 
+export const getLoginKey = (): Promise<AxiosResponse<LoginKeyResponse>> =>
+  apiGet<LoginKeyResponse>("/api/v1/auth/login-key");
+
 export const fetchMe = (): Promise<AxiosResponse<UserMeResponse>> => apiGet<UserMeResponse>("/api/v1/auth/me");
 
 export const register = (payload: RegisterRequest): Promise<AxiosResponse<{ message: string }>> =>

frontend/src/api/authClient.ts

@@ -16,6 +16,19 @@ export type UnlockResponse = {
   expiresAt: string;
 };
 
+export type LoginKeyResponse = {
+  key_id: string;
+  public_key: string;
+  challenge: string;
+  expires_at: string;
+};
+
+export type EncryptedPasswordRequest = {
+  key_id: string;
+  challenge: string;
+  ciphertext: string;
+};
+
 export const extendToken = (token: string): Promise<AxiosResponse<ExtendResponse>> =>
   authClient.post<ExtendResponse>(
     "/api/v1/auth/extend",
@@ -27,7 +40,10 @@ export const extendToken = (token: string): Promise<AxiosResponse<ExtendResponse
     }
   );
 
-export const unlockSession = (payload: { email: string; password: string }): Promise<AxiosResponse<UnlockResponse>> =>
+export const getLoginKey = (): Promise<AxiosResponse<LoginKeyResponse>> =>
+  authClient.get<LoginKeyResponse>("/api/v1/auth/login-key");
+
+export const unlockSession = (payload: EncryptedPasswordRequest): Promise<AxiosResponse<UnlockResponse>> =>
   authClient.post<UnlockResponse>("/api/v1/auth/unlock", payload);
 
 export default authClient;

frontend/src/locales/zh-CN.ts

@@ -121,11 +121,12 @@ export const TEXT = {
       screeningDate: "筛选日期",
       consentDate: "知情日期",
       enrollmentDate: "入组日期",
+      baselineDate: "基线/治疗日期",
       completionDate: "完成日期",
       dropReason: "退出原因",
       recordDate: "日期",
       content: "内容",
-      visitCode: "访视编号",
+      visitCode: "访视",
       plannedDate: "计划访视",
       actualDate: "实际访视",
       windowStart: "窗口开始",

frontend/src/session/sessionManager.ts

@@ -2,7 +2,8 @@ import router from "../router";
 import { useAuthStore } from "../store/auth";
 import { useSessionStore } from "../store/session";
 import { getToken, setToken, clearToken } from "../utils/auth";
-import { extendToken, unlockSession } from "../api/authClient";
+import { extendToken, getLoginKey, unlockSession } from "../api/authClient";
+import { encryptLoginPayload } from "../utils/loginCrypto";
 import { parseJwtExp } from "./jwt";
 
 export const IDLE_TIMEOUT_MINUTES = 30;
@@ -292,7 +293,17 @@ export const startTokenKeepAlive = () => {
 export const unlockWithPassword = async (email: string, password: string) => {
   const session = useSessionStore();
   const auth = useAuthStore();
-  const { data } = await unlockSession({ email, password });
+  const { data: loginKey } = await getLoginKey();
+  const ciphertext = await encryptLoginPayload(loginKey.public_key, {
+    email,
+    password,
+    challenge: loginKey.challenge,
+  });
+  const { data } = await unlockSession({
+    key_id: loginKey.key_id,
+    challenge: loginKey.challenge,
+    ciphertext,
+  });
   updateToken(data.accessToken);
   session.unlock();
   try {

frontend/src/store/auth.ts

@@ -1,7 +1,8 @@
 import { defineStore } from "pinia";
 import { ref } from "vue";
-import { login as apiLogin, fetchMe } from "../api/auth";
+import { getLoginKey, login as apiLogin, fetchMe } from "../api/auth";
 import { setToken, clearToken, getToken } from "../utils/auth";
+import { encryptLoginPayload } from "../utils/loginCrypto";
 import type { UserInfo } from "../types/api";
 import { useStudyStore } from "./study";
 import { useSessionStore } from "./session";
@@ -16,7 +17,17 @@ export const useAuthStore = defineStore("auth", () => {
   const login = async (email: string, password: string) => {
     loading.value = true;
     try {
-      const { data } = await apiLogin({ email, password });
+      const { data: loginKey } = await getLoginKey();
+      const ciphertext = await encryptLoginPayload(loginKey.public_key, {
+        email,
+        password,
+        challenge: loginKey.challenge,
+      });
+      const { data } = await apiLogin({
+        key_id: loginKey.key_id,
+        challenge: loginKey.challenge,
+        ciphertext,
+      });
       token.value = data.access_token;
       setToken(data.access_token);
       // 避免锁屏态下 fetchMe 被请求拦截

frontend/src/types/api.ts

@@ -15,8 +15,9 @@ export interface ApiError {
 }
 
 export interface LoginRequest {
-  email: string;
-  password: string;
+  key_id: string;
+  challenge: string;
+  ciphertext: string;
 }
 
 export interface LoginResponse {
@@ -24,6 +25,13 @@ export interface LoginResponse {
   token_type: string;
 }
 
+export interface LoginKeyResponse {
+  key_id: string;
+  public_key: string;
+  challenge: string;
+  expires_at: string;
+}
+
 export type UserRole = "PM" | "CRA" | "PV" | "IMP" | "QA" | "ADMIN";
 export type UserStatus = "PENDING" | "ACTIVE" | "REJECTED" | "DISABLED";
 
@@ -79,20 +87,22 @@ export interface Study {
   planned_enrollment_count?: number | null;
   enrollment_monthly_goal_note?: string | null;
   enrollment_stage_breakdown?: string | null;
-  summary_note?: string | null;
-  objective_note?: string | null;
   phase?: string | null;
   status: string;
   is_locked?: boolean;
-  visit_interval_days?: number | null;
-  visit_total?: number | null;
-  visit_window_start_offset?: number | null;
-  visit_window_end_offset?: number | null;
+  visit_schedule?: VisitScheduleItem[];
   created_by?: string | null;
   created_at?: string;
   role_in_study?: string | null;
 }
 
+export interface VisitScheduleItem {
+  visit_code: string;
+  baseline_offset_days: number;
+  window_before_days: number;
+  window_after_days: number;
+}
+
 export interface StudyMember {
   id: string;
   study_id: string;

frontend/src/types/setupConfig.ts

@@ -66,6 +66,13 @@ export interface SetupConfigDraft {
   centerConfirm: CenterConfirmDraft[];
 }
 
+export interface VisitScheduleItem {
+  visit_code: string;
+  baseline_offset_days: number;
+  window_before_days: number;
+  window_after_days: number;
+}
+
 export interface ProjectPublishSnapshot {
   code: string;
   name: string;
@@ -85,13 +92,8 @@ export interface ProjectPublishSnapshot {
   plan_end_date: string;
   planned_site_count: number | null;
   planned_enrollment_count: number | null;
-  summary_note: string;
-  objective_note: string;
   status: string;
-  visit_interval_days: number | null;
-  visit_total: number | null;
-  visit_window_start_offset: number | null;
-  visit_window_end_offset: number | null;
+  visit_schedule: VisitScheduleItem[];
 }
 
 export interface StudySetupConfigResponse {

frontend/src/utils/auth.ts

@@ -1,5 +1,4 @@
 const TOKEN_KEY = "ctms_token";
-const CREDENTIAL_KEY = "ctms_credential";
 
 export const getToken = (): string | null => localStorage.getItem(TOKEN_KEY);
 
@@ -10,30 +9,3 @@ export const setToken = (token: string): void => {
 export const clearToken = (): void => {
   localStorage.removeItem(TOKEN_KEY);
 };
-
-export const setCachedCredential = (email: string, password: string) => {
-  try {
-    const payload = btoa(JSON.stringify({ email, password }));
-    localStorage.setItem(CREDENTIAL_KEY, payload);
-  } catch {
-    /* ignore */
-  }
-};
-
-export const getCachedCredential = (): { email: string; password: string } | null => {
-  const value = localStorage.getItem(CREDENTIAL_KEY);
-  if (!value) return null;
-  try {
-    const parsed = JSON.parse(atob(value));
-    if (parsed?.email && parsed?.password) {
-      return { email: parsed.email, password: parsed.password };
-    }
-  } catch {
-    /* ignore */
-  }
-  return null;
-};
-
-export const clearCachedCredential = (): void => {
-  localStorage.removeItem(CREDENTIAL_KEY);
-};

frontend/src/utils/loginCrypto.test.ts

@@ -0,0 +1,18 @@
+import { describe, expect, it, vi } from "vitest";
+import { encryptLoginPayload } from "./loginCrypto";
+
+describe("encryptLoginPayload", () => {
+  it("fails with a clear error outside a secure browser context", async () => {
+    vi.stubGlobal("isSecureContext", false);
+
+    await expect(
+      encryptLoginPayload("unused", {
+        email: "admin@test.com",
+        password: "admin123",
+        challenge: "challenge-value-with-enough-length",
+      })
+    ).rejects.toThrow("当前浏览器环境不支持安全登录加密");
+
+    vi.unstubAllGlobals();
+  });
+});

frontend/src/utils/loginCrypto.ts

@@ -0,0 +1,56 @@
+const pemToArrayBuffer = (pem: string): ArrayBuffer => {
+  const base64 = pem
+    .replace(/-----BEGIN PUBLIC KEY-----/g, "")
+    .replace(/-----END PUBLIC KEY-----/g, "")
+    .replace(/\s/g, "");
+  const binary = atob(base64);
+  const bytes = new Uint8Array(binary.length);
+  for (let index = 0; index < binary.length; index += 1) {
+    bytes[index] = binary.charCodeAt(index);
+  }
+  return bytes.buffer;
+};
+
+const arrayBufferToBase64 = (buffer: ArrayBuffer): string => {
+  const bytes = new Uint8Array(buffer);
+  let binary = "";
+  bytes.forEach((byte) => {
+    binary += String.fromCharCode(byte);
+  });
+  return btoa(binary);
+};
+
+const assertSecureCryptoAvailable = () => {
+  if (!window.isSecureContext || !crypto?.subtle) {
+    throw new Error("当前浏览器环境不支持安全登录加密，请使用 HTTPS 或 localhost 访问系统");
+  }
+};
+
+export const encryptLoginPayload = async (
+  publicKeyPem: string,
+  payload: { email: string; password: string; challenge: string }
+): Promise<string> => {
+  assertSecureCryptoAvailable();
+  const publicKey = await crypto.subtle.importKey(
+    "spki",
+    pemToArrayBuffer(publicKeyPem),
+    {
+      name: "RSA-OAEP",
+      hash: "SHA-256",
+    },
+    false,
+    ["encrypt"]
+  );
+  const aesKey = await crypto.subtle.generateKey({ name: "AES-GCM", length: 256 }, true, ["encrypt"]);
+  const iv = crypto.getRandomValues(new Uint8Array(12));
+  const encoded = new TextEncoder().encode(JSON.stringify(payload));
+  const encryptedData = await crypto.subtle.encrypt({ name: "AES-GCM", iv }, aesKey, encoded);
+  const rawAesKey = await crypto.subtle.exportKey("raw", aesKey);
+  const encryptedKey = await crypto.subtle.encrypt({ name: "RSA-OAEP" }, publicKey, rawAesKey);
+  const envelope = {
+    encrypted_key: arrayBufferToBase64(encryptedKey),
+    iv: arrayBufferToBase64(iv.buffer),
+    data: arrayBufferToBase64(encryptedData),
+  };
+  return btoa(JSON.stringify(envelope));
+};

frontend/src/utils/setupPublishWorkflow.ts

@@ -118,13 +118,8 @@ const PROJECT_FIELD_LABEL_MAP: Record<keyof ProjectPublishSnapshot, string> = {
   plan_end_date: "计划结束日期",
   planned_site_count: "计划中心数",
   planned_enrollment_count: "计划入组数",
-  summary_note: "方案摘要说明",
-  objective_note: "研究目标摘要",
   status: "项目状态",
-  visit_interval_days: "访视间隔（天）",
-  visit_total: "访视总数",
-  visit_window_start_offset: "窗口期起始偏移",
-  visit_window_end_offset: "窗口期结束偏移",
+  visit_schedule: "访视计划",
 };
 
 export const buildProjectDiffRows = (

frontend/src/views/Login.vue

@@ -74,12 +74,6 @@
             </el-input>
           </el-form-item>
 
-          <div class="remember-row">
-            <el-checkbox id="remember" v-model="form.remember" class="remember-checkbox">
-              <span class="remember-text">记住此设备</span>
-            </el-checkbox>
-          </div>
-
           <el-button type="primary" :loading="loading" @click="onSubmit" size="large" class="login-btn">
             登 录
           </el-button>
@@ -100,7 +94,6 @@ import { useRouter } from "vue-router";
 import { ElMessage, type FormInstance, type FormRules } from "element-plus";
 import { useAuthStore } from "../store/auth";
 import { useStudyStore } from "../store/study";
-import { getCachedCredential, setCachedCredential, clearCachedCredential } from "../utils/auth";
 import { TEXT, requiredMessage } from "../locales";
 import { consumeLogoutReason, LOGOUT_REASON_TIMEOUT } from "../session/sessionManager";
 
@@ -111,7 +104,6 @@ const formRef = ref<FormInstance>();
 const form = reactive({
   email: "",
   password: "",
-  remember: false,
 });
 
 const rules: FormRules<typeof form> = {
@@ -129,12 +121,7 @@ onMounted(() => {
   if (logoutReason === LOGOUT_REASON_TIMEOUT) {
     ElMessage.warning("长时间未操作，已自动退出登录，请重新登录");
   }
-  const cached = getCachedCredential();
-  if (cached) {
-    form.email = cached.email;
-    form.password = cached.password;
-    form.remember = true;
-  }
+  form.email = localStorage.getItem("ctms_last_login_email") || "";
 });
 
 const onSubmit = async () => {
@@ -144,11 +131,6 @@ const onSubmit = async () => {
   loading.value = true;
   try {
     await auth.login(form.email, form.password);
-    if (form.remember) {
-      setCachedCredential(form.email, form.password);
-    } else {
-      clearCachedCredential();
-    }
     const studyStore = useStudyStore();
     if (!studyStore.currentStudy) {
       if (auth.user?.role === "ADMIN") {
@@ -327,22 +309,6 @@ const onSubmit = async () => {
   transition: background-color 5000s ease-in-out 0s;
 }
 
-.remember-row {
-  display: flex;
-  align-items: center;
-  justify-content: flex-start;
-  margin: -6px 0 18px;
-}
-
-.remember-checkbox :deep(.el-checkbox__label) {
-  padding-left: 8px;
-}
-
-.remember-text {
-  color: #64748b;
-  font-size: 13px;
-}
-
 .login-btn {
   width: 100%;
   height: 48px;

frontend/src/views/admin/ProjectDetail.vue

@@ -471,55 +471,12 @@
           </el-tab-pane>
 
           <el-tab-pane v-if="showStep1SummaryTab" label="方案摘要" name="summary">
-            <el-form v-if="canEditStep1Summary" label-width="120px" class="detail-form" label-position="top">
-              <el-row :gutter="24">
-                <el-col :span="6">
-                  <el-form-item :label="TEXT.common.fields.visitTotal">
-                    <el-input-number v-model="form.visit_total" :min="1" :max="50" :step="1" controls-position="right" class="w-full" />
-                  </el-form-item>
-                </el-col>
-                <el-col :span="6">
-                  <el-form-item :label="TEXT.common.fields.visitIntervalDays">
-                    <el-input-number v-model="form.visit_interval_days" :min="1" :max="365" :step="1" controls-position="right" class="w-full" />
-                  </el-form-item>
-                </el-col>
-                <el-col :span="6">
-                  <el-form-item :label="TEXT.common.fields.visitWindowStartOffset">
-                    <el-input-number v-model="form.visit_window_start_offset" :min="-365" :max="365" :step="1" controls-position="right" class="w-full" />
-                  </el-form-item>
-                </el-col>
-                <el-col :span="6">
-                  <el-form-item :label="TEXT.common.fields.visitWindowEndOffset">
-                    <el-input-number v-model="form.visit_window_end_offset" :min="-365" :max="365" :step="1" controls-position="right" class="w-full" />
-                  </el-form-item>
-                </el-col>
-              </el-row>
-              <el-row :gutter="24">
-                <el-col :span="12">
-                  <el-form-item label="方案摘要说明">
-                    <el-input v-model="form.summary_note" type="textarea" :rows="3" placeholder="用于展示项目信息概览说明" />
-                  </el-form-item>
-                </el-col>
-                <el-col :span="12">
-                  <el-form-item label="研究目标摘要">
-                    <el-input v-model="form.objective_note" type="textarea" :rows="3" placeholder="用于展示研究目标摘要" />
-                  </el-form-item>
-                </el-col>
-              </el-row>
-            </el-form>
-
-            <div v-else class="info-grid">
-              <div
-                v-for="item in summaryInfoItems"
-                :key="item.label"
-                class="info-item"
-                :class="{ 'is-updated': item.updated && shouldShowPreviewUpdateMark }"
-              >
-                <span class="info-label">{{ item.label }}</span>
-                <span class="info-value-wrap">
-                  <span class="info-value">{{ item.value || "-" }}</span>
+            <div class="info-group summary-display-group">
+              <div class="info-group-title-row">
+                <div class="info-group-title">访视计划</div>
+                <div class="info-group-title-actions">
                   <el-tag
-                    v-if="item.updated && shouldShowPreviewUpdateMark"
+                    v-if="isProjectSnapshotFieldUpdated('visit_schedule') && shouldShowPreviewUpdateMark"
                     size="small"
                     type="warning"
                     effect="plain"
@@ -527,7 +484,33 @@
                   >
                     已更新
                   </el-tag>
-                </span>
+                  <el-button
+                    v-if="!isPublishedView"
+                    type="primary"
+                    class="info-group-edit-btn"
+                    :disabled="!canEditSetup"
+                    @click="startStep1SectionEdit('summary')"
+                  >
+                    编辑
+                  </el-button>
+                </div>
+              </div>
+              <div class="visit-schedule-display">
+                <div class="visit-schedule-display-head">
+                  <span>访视</span>
+                  <span>基线后天数</span>
+                  <span>访视窗</span>
+                </div>
+                <div
+                  v-for="(row, index) in summaryVisitScheduleRows"
+                  :key="`${row.visit_code || 'visit'}-${index}`"
+                  class="visit-schedule-display-row"
+                >
+                  <span class="visit-schedule-display-code">{{ row.visit_code || "-" }}</span>
+                  <span>{{ row.baseline_offset_days }} 天</span>
+                  <span>{{ formatVisitWindow(row) }}</span>
+                </div>
+                <div v-if="!summaryVisitScheduleRows.length" class="visit-schedule-display-empty">暂无访视计划</div>
               </div>
             </div>
           </el-tab-pane>
@@ -1661,6 +1644,100 @@
       </template>
     </el-dialog>
 
+    <el-dialog
+      v-model="visitScheduleDialogVisible"
+      title="编辑访视计划"
+      width="min(860px, calc(100vw - 32px))"
+      :close-on-click-modal="false"
+      :show-close="false"
+      class="visit-schedule-dialog"
+    >
+      <el-form label-width="120px" class="detail-form visit-schedule-dialog-form" label-position="top">
+        <div class="summary-section-bar">
+          <el-button plain size="small" @click="addVisitScheduleRow">添加访视</el-button>
+        </div>
+          <div class="visit-schedule-editor">
+            <div class="visit-schedule-head">
+            <span>访视</span>
+            <span>基线后天数</span>
+            <span>窗口前（天）</span>
+            <span>窗口后（天）</span>
+            <span />
+          </div>
+          <div
+            v-for="(row, index) in form.visit_schedule"
+            :key="`${row.visit_code || 'visit'}-${index}`"
+            class="visit-schedule-row"
+            :class="{
+              'is-dragging': visitScheduleDragIndex === index,
+              'insert-before': isVisitScheduleInsertTarget(index, 'before'),
+              'insert-after': isVisitScheduleInsertTarget(index, 'after'),
+            }"
+            draggable="true"
+            aria-label="拖拽调整访视顺序"
+            @dragstart="handleVisitScheduleDragStart(index, $event)"
+            @dragover.prevent="handleVisitScheduleDragOver(index, $event)"
+            @drop.prevent="handleVisitScheduleDrop(index)"
+            @dragenter.prevent="handleVisitScheduleDragOver(index, $event)"
+            @dragend="handleVisitScheduleDragEnd"
+          >
+            <div class="visit-field visit-code-field">
+              <span class="visit-field-label">访视</span>
+              <el-select
+                v-model="row.visit_code"
+                filterable
+                allow-create
+                default-first-option
+                placeholder="选择或输入访视"
+                class="w-full"
+                @change="handleVisitScheduleCodeChange(index, $event)"
+              >
+                <el-option-group label="常规访视">
+                  <el-option label="常规访视（自动生成 Vn）" :value="regularVisitOptionValue" />
+                  <el-option label="安全性随访（自动生成 Vn）" :value="safetyFollowUpVisitOptionValue" />
+                </el-option-group>
+                <el-option-group label="特殊访视">
+                  <el-option
+                    v-for="option in specialVisitOptions"
+                    :key="option"
+                    :label="option"
+                    :value="option"
+                  />
+                </el-option-group>
+              </el-select>
+            </div>
+            <div class="visit-field">
+              <span class="visit-field-label">基线后天数</span>
+              <el-input-number v-model="row.baseline_offset_days" :min="0" :max="3650" :step="1" controls-position="right" class="w-full" />
+            </div>
+            <div class="visit-field">
+              <span class="visit-field-label">窗口前</span>
+              <el-input-number v-model="row.window_before_days" :min="0" :max="365" :step="1" controls-position="right" class="w-full" />
+            </div>
+            <div class="visit-field">
+              <span class="visit-field-label">窗口后</span>
+              <el-input-number v-model="row.window_after_days" :min="0" :max="365" :step="1" controls-position="right" class="w-full" />
+            </div>
+            <el-button
+              :icon="Delete"
+              text
+              type="danger"
+              class="visit-schedule-remove"
+              @click="removeVisitScheduleRow(index)"
+            />
+          </div>
+        </div>
+      </el-form>
+      <template #footer>
+        <div class="visit-schedule-dialog-footer">
+          <el-button :disabled="drawerConfirmLoading || submitting" @click="cancelVisitScheduleDialogEdit">取消</el-button>
+          <el-button type="primary" :loading="drawerConfirmLoading || submitting" :disabled="!canEditSetup" @click="saveVisitScheduleDialogEdit">
+            保存
+          </el-button>
+        </div>
+      </template>
+    </el-dialog>
+
     <el-drawer
       v-if="projectMilestoneEditorVisible"
       v-model="projectMilestoneEditorVisible"
@@ -1984,6 +2061,7 @@ import type {
   StudySetupConfigResponse,
   StudySetupConfigVersionItem,
   StudySetupConfigUpsertPayload,
+  VisitScheduleItem,
 } from "../../types/setupConfig";
 import StateLoading from "../../components/StateLoading.vue";
 import { useStudyStore } from "../../store/study";
@@ -2145,10 +2223,16 @@ const infoTab = ref<"basic" | "summary">("basic");
 const step1EditSection = ref<Step1EditSection>("all");
 const isEditing = ref(false);
 const drawerClosing = ref(false);
+const visitScheduleDialogVisible = ref(false);
 const drawerVisible = computed(() => {
+  if (visitScheduleDialogVisible.value) return false;
   if (activeStep.value === 2 || activeStep.value === 4) return false;
   return isEditing.value || drawerClosing.value;
 });
+const visitScheduleDragIndex = ref<number | null>(null);
+const visitScheduleDragOverIndex = ref<number | null>(null);
+type VisitScheduleInsertPosition = "before" | "after";
+const visitScheduleInsertPosition = ref<VisitScheduleInsertPosition>("before");
 const drawerCloseTimer = ref<number | undefined>(undefined);
 const submitting = ref(false);
 const formRef = ref<FormInstance>();
@@ -2311,14 +2395,148 @@ const form = ref({
   phase: "",
   status: "DRAFT",
   scope: "国内",
-  summary_note: "",
-  objective_note: "",
-  visit_interval_days: null as number | null,
-  visit_total: null as number | null,
-  visit_window_start_offset: null as number | null,
-  visit_window_end_offset: null as number | null,
+  visit_schedule: [] as VisitScheduleItem[],
 });
 const formBaselineSnapshot = ref("");
+const regularVisitOptionValue = "__REGULAR_VISIT__";
+const safetyFollowUpVisitOptionValue = "__SAFETY_FOLLOW_UP_VISIT__";
+const specialVisitOptions = ["筛选访视", "基线访视", "终止治疗", "提前终止"];
+
+const getNextRegularVisitCode = (excludeIndex?: number): string => {
+  const maxRegularIndex = form.value.visit_schedule.reduce((maxIndex, row, rowIndex) => {
+    if (rowIndex === excludeIndex) return maxIndex;
+    const match = /^V(\d+)$/.exec((row.visit_code || "").trim());
+    if (!match) return maxIndex;
+    return Math.max(maxIndex, Number(match[1]));
+  }, 0);
+  return `V${maxRegularIndex + 1}`;
+};
+
+const getNextSafetyFollowUpVisitCode = (excludeIndex?: number): string => {
+  const maxSafetyFollowUpIndex = form.value.visit_schedule.reduce((maxIndex, row, rowIndex) => {
+    if (rowIndex === excludeIndex) return maxIndex;
+    const match = /^安全性随访V(\d+)$/.exec((row.visit_code || "").trim());
+    if (!match) return maxIndex;
+    return Math.max(maxIndex, Number(match[1]));
+  }, 0);
+  return `安全性随访V${maxSafetyFollowUpIndex + 1}`;
+};
+
+const hasDuplicateVisitCode = (visitCode: string, currentIndex: number): boolean => {
+  const normalizedCode = visitCode.trim();
+  if (!normalizedCode) return false;
+  return form.value.visit_schedule.some(
+    (row, rowIndex) => rowIndex !== currentIndex && (row.visit_code || "").trim() === normalizedCode
+  );
+};
+
+const normalizeVisitSchedule = (rows: VisitScheduleItem[] | undefined | null): VisitScheduleItem[] =>
+  (rows || []).map((row) => ({
+    visit_code: (row.visit_code || "").trim(),
+    baseline_offset_days: Number(row.baseline_offset_days || 0),
+    window_before_days: Number(row.window_before_days || 0),
+    window_after_days: Number(row.window_after_days || 0),
+  }));
+
+const addVisitScheduleRow = () => {
+  form.value.visit_schedule.push({
+    visit_code: getNextRegularVisitCode(),
+    baseline_offset_days: 0,
+    window_before_days: 0,
+    window_after_days: 0,
+  });
+};
+
+const removeVisitScheduleRow = (index: number) => {
+  form.value.visit_schedule.splice(index, 1);
+};
+
+const handleVisitScheduleCodeChange = (index: number, value: string) => {
+  const row = form.value.visit_schedule[index];
+  if (!row) return;
+  let nextVisitCode = String(value || "").trim();
+  if (nextVisitCode === regularVisitOptionValue) {
+    nextVisitCode = getNextRegularVisitCode(index);
+  } else if (nextVisitCode === safetyFollowUpVisitOptionValue) {
+    nextVisitCode = getNextSafetyFollowUpVisitCode(index);
+  }
+  if (hasDuplicateVisitCode(nextVisitCode, index)) {
+    row.visit_code = "";
+    ElMessage.warning(`访视已存在：${nextVisitCode}`);
+    return;
+  }
+  row.visit_code = nextVisitCode;
+};
+
+const handleVisitScheduleDragStart = (index: number, event: DragEvent) => {
+  visitScheduleDragIndex.value = index;
+  visitScheduleDragOverIndex.value = index;
+  visitScheduleInsertPosition.value = "before";
+  event.dataTransfer?.setData("text/plain", String(index));
+  if (event.dataTransfer) {
+    event.dataTransfer.effectAllowed = "move";
+  }
+};
+
+const handleVisitScheduleDragOver = (index: number, event: DragEvent) => {
+  if (visitScheduleDragIndex.value === null) return;
+  const target = event.currentTarget as HTMLElement | null;
+  if (target) {
+    const rect = target.getBoundingClientRect();
+    visitScheduleInsertPosition.value = event.clientY < rect.top + rect.height / 2 ? "before" : "after";
+  }
+  visitScheduleDragOverIndex.value = index;
+};
+
+const handleVisitScheduleDrop = (targetIndex: number) => {
+  const sourceIndex = visitScheduleDragIndex.value;
+  if (sourceIndex === null) {
+    handleVisitScheduleDragEnd();
+    return;
+  }
+  let insertIndex = visitScheduleInsertPosition.value === "after" ? targetIndex + 1 : targetIndex;
+  if (sourceIndex === targetIndex || sourceIndex + 1 === insertIndex) {
+    handleVisitScheduleDragEnd();
+    return;
+  }
+  const nextRows = [...form.value.visit_schedule];
+  const [movedRow] = nextRows.splice(sourceIndex, 1);
+  if (!movedRow) {
+    handleVisitScheduleDragEnd();
+    return;
+  }
+  if (sourceIndex < insertIndex) {
+    insertIndex -= 1;
+  }
+  nextRows.splice(insertIndex, 0, movedRow);
+  form.value.visit_schedule = nextRows;
+  handleVisitScheduleDragEnd();
+};
+
+const handleVisitScheduleDragEnd = () => {
+  visitScheduleDragIndex.value = null;
+  visitScheduleDragOverIndex.value = null;
+  visitScheduleInsertPosition.value = "before";
+};
+
+const isVisitScheduleInsertTarget = (index: number, position: VisitScheduleInsertPosition) =>
+  visitScheduleDragIndex.value !== null &&
+  visitScheduleDragIndex.value !== index &&
+  visitScheduleDragOverIndex.value === index &&
+  visitScheduleInsertPosition.value === position;
+
+const formatVisitSchedule = (rows: VisitScheduleItem[] | undefined | null): string => {
+  const normalized = normalizeVisitSchedule(rows);
+  if (!normalized.length) return "-";
+  return normalized
+    .map(
+      (row) =>
+        `${row.visit_code || "-"}：基线+${row.baseline_offset_days}天，窗口-${row.window_before_days}/+${row.window_after_days}天`
+    )
+    .join("；");
+};
+
+const formatVisitWindow = (row: VisitScheduleItem): string => `-${row.window_before_days} / +${row.window_after_days} 天`;
 
 const setupDraft = reactive<SetupConfigDraft>({
   projectMilestones: [],
@@ -2354,9 +2572,6 @@ const canEditSetup = computed(
 const canMutateDraft = () => canEditSetup.value && !isPublishedView.value;
 const canEditStep1BasicGroup = (group: Exclude<Step1EditSection, "all" | "summary">) =>
   activeStep.value === 0 && isEditing.value && (step1EditSection.value === "all" || step1EditSection.value === group);
-const canEditStep1Summary = computed(
-  () => activeStep.value === 0 && isEditing.value && (step1EditSection.value === "all" || step1EditSection.value === "summary")
-);
 const isStep1BasicScopedEdit = computed(
   () => activeStep.value === 0 && isEditing.value && ["project", "research", "execution"].includes(step1EditSection.value)
 );
@@ -2370,7 +2585,7 @@ const stepActionMode = computed<StepActionMode>(() => {
     case 2:
       return "edit";
     case 0:
-      return infoTab.value === "summary" ? "edit" : "none";
+      return "none";
     case 1:
       return "project-milestone";
     case 3:
@@ -2483,14 +2698,9 @@ const serializeFormForCompare = (): string =>
     plan_start_date: "",
     plan_end_date: "",
     planned_enrollment_count: null,
-    summary_note: form.value.summary_note || "",
-    objective_note: form.value.objective_note || "",
     phase: form.value.phase || "",
     status: form.value.status || "",
-    visit_interval_days: form.value.visit_interval_days,
-    visit_total: form.value.visit_total,
-    visit_window_start_offset: form.value.visit_window_start_offset,
-    visit_window_end_offset: form.value.visit_window_end_offset,
+    visit_schedule: normalizeVisitSchedule(form.value.visit_schedule),
   });
 const serializeSetupForCompare = (): string => JSON.stringify(clone(setupDraft));
 const buildProjectPublishSnapshotFromStudy = (study: Partial<Study> | null | undefined): ProjectPublishSnapshot => ({
@@ -2512,13 +2722,8 @@ const buildProjectPublishSnapshotFromStudy = (study: Partial<Study> | null | und
   plan_end_date: study?.plan_end_date || "",
   planned_site_count: study?.planned_site_count ?? null,
   planned_enrollment_count: study?.planned_enrollment_count ?? null,
-  summary_note: study?.summary_note || "",
-  objective_note: study?.objective_note || "",
   status: study?.status || "",
-  visit_interval_days: study?.visit_interval_days ?? null,
-  visit_total: study?.visit_total ?? null,
-  visit_window_start_offset: study?.visit_window_start_offset ?? null,
-  visit_window_end_offset: study?.visit_window_end_offset ?? null,
+  visit_schedule: normalizeVisitSchedule(study?.visit_schedule),
 });
 const buildProjectPublishSnapshot = (): ProjectPublishSnapshot =>
   buildProjectPublishSnapshotFromStudy({
@@ -2540,13 +2745,8 @@ const buildProjectPublishSnapshot = (): ProjectPublishSnapshot =>
     plan_end_date: form.value.plan_end_date,
     planned_site_count: form.value.planned_site_count,
     planned_enrollment_count: form.value.planned_enrollment_count,
-    summary_note: form.value.summary_note,
-    objective_note: form.value.objective_note,
     status: form.value.status,
-    visit_interval_days: form.value.visit_interval_days,
-    visit_total: form.value.visit_total,
-    visit_window_start_offset: form.value.visit_window_start_offset,
-    visit_window_end_offset: form.value.visit_window_end_offset,
+    visit_schedule: normalizeVisitSchedule(form.value.visit_schedule),
   });
 const serializeProjectForPublishCompare = (): string => JSON.stringify(buildProjectPublishSnapshot());
 const hasFormUnsavedChanges = computed(() => Boolean(formBaselineSnapshot.value && serializeFormForCompare() !== formBaselineSnapshot.value));
@@ -2774,14 +2974,7 @@ const executionInfoItems = computed<DisplayInfoItem[]>(() => [
   },
 ]);
 
-const summaryInfoItems = computed<DisplayInfoItem[]>(() => [
-  { label: "访视总数", value: toDisplayNumber(currentProjectPublishSnapshot.value.visit_total), updated: isProjectSnapshotFieldUpdated("visit_total") },
-  { label: "访视间隔（天）", value: toDisplayNumber(currentProjectPublishSnapshot.value.visit_interval_days), updated: isProjectSnapshotFieldUpdated("visit_interval_days") },
-  { label: "窗口期起始偏移", value: toDisplayNumber(currentProjectPublishSnapshot.value.visit_window_start_offset), updated: isProjectSnapshotFieldUpdated("visit_window_start_offset") },
-  { label: "窗口期结束偏移", value: toDisplayNumber(currentProjectPublishSnapshot.value.visit_window_end_offset), updated: isProjectSnapshotFieldUpdated("visit_window_end_offset") },
-  { label: "方案摘要说明", value: currentProjectPublishSnapshot.value.summary_note || "-", updated: isProjectSnapshotFieldUpdated("summary_note") },
-  { label: "研究目标摘要", value: currentProjectPublishSnapshot.value.objective_note || "-", updated: isProjectSnapshotFieldUpdated("objective_note") },
-]);
+const summaryVisitScheduleRows = computed<VisitScheduleItem[]>(() => normalizeVisitSchedule(currentProjectPublishSnapshot.value.visit_schedule));
 
 const rules = ref<FormRules>({
   code: [{ required: true, message: requiredMessage(TEXT.common.fields.projectCode), trigger: "blur" }],
@@ -4283,12 +4476,7 @@ const syncForm = (data: Study | null) => {
   form.value.phase = data?.phase || "";
   form.value.status = data?.status || "DRAFT";
   form.value.scope = "国内";
-  form.value.summary_note = data?.summary_note || "";
-  form.value.objective_note = data?.objective_note || "";
-  form.value.visit_interval_days = data?.visit_interval_days ?? null;
-  form.value.visit_total = data?.visit_total ?? null;
-  form.value.visit_window_start_offset = data?.visit_window_start_offset ?? null;
-  form.value.visit_window_end_offset = data?.visit_window_end_offset ?? null;
+  form.value.visit_schedule = normalizeVisitSchedule(data?.visit_schedule);
   formBaselineSnapshot.value = serializeFormForCompare();
 };
 
@@ -4498,6 +4686,9 @@ const startStep1SectionEdit = (section: Exclude<Step1EditSection, "all">) => {
   startEdit();
   if (isEditing.value) {
     step1EditSection.value = section;
+    if (section === "summary") {
+      visitScheduleDialogVisible.value = true;
+    }
   }
 };
 
@@ -4512,12 +4703,17 @@ const cancelEdit = () => {
   }
   isEditing.value = false;
   step1EditSection.value = "all";
+  visitScheduleDialogVisible.value = false;
   clearSetupValidationErrors();
   formBaselineSnapshot.value = serializeFormForCompare();
 };
 
 const closeEditDrawer = () => {
   if (!isEditing.value || drawerClosing.value) return;
+  if (visitScheduleDialogVisible.value) {
+    cancelEdit();
+    return;
+  }
   drawerClosing.value = true;
   drawerCloseTimer.value = window.setTimeout(() => {
     cancelEdit();
@@ -4528,6 +4724,15 @@ const closeEditDrawer = () => {
 
 const closeEditDrawerAfterSave = (onClosed?: () => void) => {
   if (!isEditing.value || drawerClosing.value) return;
+  if (visitScheduleDialogVisible.value) {
+    visitScheduleDialogVisible.value = false;
+    isEditing.value = false;
+    step1EditSection.value = "all";
+    clearSetupValidationErrors();
+    formBaselineSnapshot.value = serializeFormForCompare();
+    onClosed?.();
+    return;
+  }
   drawerClosing.value = true;
   drawerCloseTimer.value = window.setTimeout(() => {
     isEditing.value = false;
@@ -4540,6 +4745,32 @@ const closeEditDrawerAfterSave = (onClosed?: () => void) => {
   }, 220);
 };
 
+const cancelVisitScheduleDialogEdit = () => {
+  cancelEdit();
+};
+
+const saveVisitScheduleDialogEdit = async () => {
+  if (!canEditSetup.value) return;
+  drawerConfirmLoading.value = true;
+  try {
+    const projectChanged = refreshProjectDirtyState();
+    if (projectChanged) {
+      persistProjectDraftToLocal();
+    } else {
+      clearLocalProjectDraft();
+      markServerSyncedIfNoLocalChanges();
+    }
+    formBaselineSnapshot.value = serializeFormForCompare();
+    visitScheduleDialogVisible.value = false;
+    isEditing.value = false;
+    step1EditSection.value = "all";
+    clearSetupValidationErrors();
+    ElMessage.success("访视计划已保存");
+  } finally {
+    drawerConfirmLoading.value = false;
+  }
+};
+
 const handleDrawerConfirm = async () => {
   if (!canEditSetup.value) return;
   drawerConfirmLoading.value = true;
@@ -4603,14 +4834,9 @@ const saveEdit = async (closeAfterSave = true, showSuccessMessage = true): Promi
       plan_end_date: form.value.plan_end_date || null,
       planned_site_count: form.value.planned_site_count,
       planned_enrollment_count: form.value.planned_enrollment_count,
-      summary_note: form.value.summary_note?.trim() || null,
-      objective_note: form.value.objective_note?.trim() || null,
       phase: form.value.phase?.trim() || null,
       status: form.value.status,
-      visit_interval_days: form.value.visit_interval_days,
-      visit_total: form.value.visit_total,
-      visit_window_start_offset: form.value.visit_window_start_offset,
-      visit_window_end_offset: form.value.visit_window_end_offset,
+      visit_schedule: normalizeVisitSchedule(form.value.visit_schedule),
     });
     project.value = data as Study;
     syncFormFromProjectWithoutSetupLink(project.value);
@@ -5225,12 +5451,7 @@ const downloadVersionRaw = (versionItem: StudySetupConfigVersionItem) => {
     ["项目状态", projectSnapshot?.status ? statusLabel(projectSnapshot.status) : "-"],
     ["计划中心数", projectSnapshot?.planned_site_count ?? "-"],
     ["计划入组数", projectSnapshot?.planned_enrollment_count ?? "-"],
-    ["访视总数", projectSnapshot?.visit_total ?? "-"],
-    ["访视间隔（天）", projectSnapshot?.visit_interval_days ?? "-"],
-    ["窗口期起始偏移", projectSnapshot?.visit_window_start_offset ?? "-"],
-    ["窗口期结束偏移", projectSnapshot?.visit_window_end_offset ?? "-"],
-    ["方案摘要说明", projectSnapshot?.summary_note || "-"],
-    ["研究目标摘要", projectSnapshot?.objective_note || "-"],
+    ["访视计划", formatVisitSchedule(projectSnapshot?.visit_schedule)],
   ];
 
   const step2Headers = ["里程碑", "计划日期", "开始日期", "结束日期", "耗时(天)", "负责人", "状态", "备注"];
@@ -6962,6 +7183,7 @@ onBeforeUnmount(() => {
 }
 
 .setup-section {
+  position: relative;
   padding: 8px 12px 12px;
   border-bottom: 1px solid #edf2f8;
   background: #ffffff;
@@ -7559,6 +7781,12 @@ onBeforeUnmount(() => {
   gap: 8px;
 }
 
+.info-group-title-actions {
+  display: flex;
+  align-items: center;
+  gap: 10px;
+}
+
 .info-group-edit-btn {
   min-width: 64px;
   height: 28px;
@@ -7674,6 +7902,7 @@ onBeforeUnmount(() => {
 
 .setup-info-tabs {
   margin-top: -8px;
+  position: relative;
 }
 
 .setup-section :deep(.el-tabs__item) {
@@ -8017,6 +8246,202 @@ onBeforeUnmount(() => {
   margin-bottom: 8px;
 }
 
+.summary-section-bar {
+  display: flex;
+  align-items: center;
+  justify-content: flex-end;
+  gap: 12px;
+  margin: 10px 0 8px;
+}
+
+.summary-display-group {
+  padding-top: 16px;
+}
+
+.visit-schedule-display {
+  width: 100%;
+  border: 1px solid #e1e9f3;
+  border-radius: 8px;
+  overflow: hidden;
+  background: #fff;
+}
+
+.visit-schedule-display-head,
+.visit-schedule-display-row {
+  display: grid;
+  grid-template-columns: minmax(160px, 0.8fr) minmax(160px, 0.8fr) minmax(220px, 1fr);
+  gap: 16px;
+  align-items: center;
+}
+
+.visit-schedule-display-head {
+  min-height: 40px;
+  padding: 0 14px;
+  background: #f3f7fc;
+  border-bottom: 1px solid #dce6f2;
+  color: #35516f;
+  font-size: 13px;
+  font-weight: 800;
+}
+
+.visit-schedule-display-row {
+  min-height: 42px;
+  padding: 0 14px;
+  border-bottom: 1px solid #edf2f7;
+  color: #334155;
+  font-size: 13px;
+}
+
+.visit-schedule-display-row:last-of-type {
+  border-bottom: none;
+}
+
+.visit-schedule-display-code {
+  color: #0f172a;
+  font-weight: 700;
+}
+
+.visit-schedule-display-empty {
+  padding: 18px 14px;
+  color: #94a3b8;
+  font-size: 13px;
+  text-align: center;
+}
+
+.visit-schedule-editor {
+  width: 100%;
+  border: 1px solid #e1e9f3;
+  border-radius: 8px;
+  overflow: hidden;
+  background: #fff;
+}
+
+.visit-schedule-head,
+.visit-schedule-row {
+  display: grid;
+  grid-template-columns: minmax(220px, 0.9fr) minmax(210px, 1fr) minmax(150px, 0.75fr) minmax(150px, 0.75fr) 48px;
+  gap: 12px;
+  align-items: center;
+}
+
+.visit-schedule-head {
+  min-height: 40px;
+  padding: 0 12px;
+  background: #f3f7fc;
+  border-bottom: 1px solid #dce6f2;
+  color: #35516f;
+  font-size: 13px;
+  font-weight: 800;
+}
+
+.visit-schedule-row {
+  position: relative;
+  padding: 9px 12px;
+  border-bottom: 1px solid #edf2f7;
+  cursor: grab;
+  transition: background-color 0.16s ease, box-shadow 0.16s ease, opacity 0.16s ease;
+}
+
+.visit-schedule-row:active {
+  cursor: grabbing;
+}
+
+.visit-schedule-row:last-child {
+  border-bottom: none;
+}
+
+.visit-schedule-row.is-dragging {
+  background: #f8fbff;
+  opacity: 0.62;
+}
+
+.visit-schedule-row.insert-before::before,
+.visit-schedule-row.insert-after::after {
+  position: absolute;
+  left: 12px;
+  right: 12px;
+  z-index: 2;
+  height: 3px;
+  border-radius: 999px;
+  background: #2f80ed;
+  box-shadow: 0 0 0 3px rgba(47, 128, 237, 0.14);
+  content: "";
+}
+
+.visit-schedule-row.insert-before::before {
+  top: -2px;
+}
+
+.visit-schedule-row.insert-after::after {
+  bottom: -2px;
+}
+
+.visit-schedule-row.insert-before,
+.visit-schedule-row.insert-after {
+  background: #f8fbff;
+}
+
+.visit-code-field {
+  min-width: 0;
+}
+
+.visit-field {
+  min-width: 0;
+}
+
+.visit-field-label {
+  display: none;
+  margin-bottom: 5px;
+  color: #64748b;
+  font-size: 12px;
+  font-weight: 700;
+}
+
+.visit-schedule-remove {
+  justify-self: center;
+  width: 32px;
+  height: 32px;
+}
+
+.visit-schedule-add {
+  margin-top: 0;
+}
+
+.visit-schedule-dialog :deep(.el-dialog) {
+  border-radius: 10px;
+}
+
+.visit-schedule-dialog :deep(.el-dialog__header) {
+  padding: 18px 20px 12px;
+  margin: 0;
+  border-bottom: 1px solid #e6edf7;
+}
+
+.visit-schedule-dialog :deep(.el-dialog__title) {
+  color: #0f172a;
+  font-size: 18px;
+  font-weight: 700;
+}
+
+.visit-schedule-dialog :deep(.el-dialog__body) {
+  padding: 14px 20px 18px;
+}
+
+.visit-schedule-dialog :deep(.el-dialog__footer) {
+  padding: 12px 20px;
+  border-top: 1px solid #e6edf7;
+}
+
+.visit-schedule-dialog-form .summary-section-bar {
+  margin-top: 0;
+}
+
+.visit-schedule-dialog-footer {
+  display: flex;
+  justify-content: flex-end;
+  gap: 10px;
+}
+
 .conflict-readable-diff :deep(.el-table th.el-table__cell) {
   background: #f7faff;
   color: #2f4672;
@@ -8040,6 +8465,33 @@ onBeforeUnmount(() => {
     grid-template-columns: 1fr;
   }
 
+  .visit-schedule-head {
+    display: none;
+  }
+
+  .visit-schedule-display-head {
+    display: none;
+  }
+
+  .visit-schedule-display-row {
+    grid-template-columns: 1fr;
+    gap: 4px;
+    padding: 10px 14px;
+  }
+
+  .visit-schedule-row {
+    grid-template-columns: 1fr;
+    gap: 10px;
+  }
+
+  .visit-field-label {
+    display: block;
+  }
+
+  .visit-schedule-remove {
+    justify-self: flex-end;
+  }
+
   .flow-label {
     font-size: 14px;
   }

frontend/src/views/subjects/SubjectDetail.vue

@@ -26,7 +26,7 @@
     </div>
 
     <el-card class="unified-shell subject-shell" v-loading="loading">
-      <el-descriptions :column="2" border>
+      <el-descriptions class="subject-overview-descriptions" :column="2" border>
         <el-descriptions-item :label="TEXT.modules.subjectManagement.screeningNo">{{ detail.subject_no || TEXT.common.fallback }}</el-descriptions-item>
         <el-descriptions-item :label="TEXT.common.fields.site">{{ siteMap[detail.site_id] || TEXT.common.fallback }}</el-descriptions-item>
         <el-descriptions-item :label="TEXT.common.fields.status">
@@ -59,6 +59,16 @@
           />
           <span v-else>{{ displayDate(detail.enrollment_date) }}</span>
         </el-descriptions-item>
+        <el-descriptions-item :label="TEXT.common.fields.baselineDate">
+          <el-date-picker
+            v-if="subjectEditing"
+            v-model="subjectForm.baseline_date"
+            type="date"
+            value-format="YYYY-MM-DD"
+            size="small"
+          />
+          <span v-else>{{ displayDate(detail.baseline_date) }}</span>
+        </el-descriptions-item>
         <el-descriptions-item :label="TEXT.common.fields.completionDate">
           <el-date-picker
             v-if="subjectEditing"
@@ -76,14 +86,14 @@
       </el-descriptions>
     </el-card>
 
-    <el-card class="unified-shell subject-shell">
+    <el-card class="unified-shell subject-shell subject-tabs-shell">
+      <div class="subject-tabs-action">
+        <el-button type="primary" :disabled="isReadOnly" @click="currentTabAction.onClick">
+          {{ currentTabAction.label }}
+        </el-button>
+      </div>
       <el-tabs v-model="activeTab">
         <el-tab-pane :label="TEXT.modules.subjectDetail.tabs.history" name="history">
-          <div class="tab-actions">
-            <el-button type="primary" :disabled="isReadOnly" @click="openHistoryDialog()">
-              {{ TEXT.common.actions.newHistory }}
-            </el-button>
-          </div>
           <el-table :data="historyItems" v-loading="loadingHistory" style="width: 100%" class="subject-detail-table" table-layout="fixed">
             <el-table-column prop="record_date" :label="TEXT.common.fields.recordDate" show-overflow-tooltip>
               <template #default="scope">{{ displayDate(scope.row.record_date) }}</template>
@@ -118,11 +128,6 @@
         </el-tab-pane>
 
         <el-tab-pane :label="TEXT.modules.subjectDetail.tabs.visits" name="visits">
-          <div class="tab-actions">
-            <el-button type="primary" :disabled="isReadOnly" @click="openVisitDialog()">
-              {{ TEXT.common.actions.newVisit }}
-            </el-button>
-          </div>
           <el-table :data="visitItems" v-loading="loadingVisits" style="width: 100%" class="subject-detail-table" table-layout="fixed">
             <el-table-column prop="visit_code" :label="TEXT.common.fields.visitCode" show-overflow-tooltip />
             <el-table-column prop="planned_date" :label="TEXT.common.fields.plannedDate" show-overflow-tooltip>
@@ -201,11 +206,6 @@
         </el-tab-pane>
 
         <el-tab-pane :label="TEXT.modules.subjectDetail.tabs.ae" name="ae">
-          <div class="tab-actions">
-            <el-button type="primary" :disabled="isReadOnly" @click="openAeDialog()">
-              {{ TEXT.common.actions.newAe }}
-            </el-button>
-          </div>
           <el-table :data="aeItems" v-loading="loadingAes" style="width: 100%" class="subject-detail-table" table-layout="fixed">
             <el-table-column prop="onset_date" :label="TEXT.common.fields.occurDate" show-overflow-tooltip>
               <template #default="scope">{{ displayDate(scope.row.onset_date) }}</template>
@@ -259,11 +259,6 @@
         </el-tab-pane>
 
         <el-tab-pane :label="TEXT.modules.subjectDetail.tabs.pd" name="pd">
-          <div class="tab-actions">
-            <el-button type="primary" :disabled="isReadOnly" @click="openPdDialog()">
-              {{ TEXT.modules.subjectDetail.newPd }}
-            </el-button>
-          </div>
           <el-table :data="pdItems" v-loading="loadingPds" style="width: 100%" class="subject-detail-table" table-layout="fixed">
             <el-table-column prop="pd_no" :label="TEXT.common.fields.pdNo" show-overflow-tooltip />
             <el-table-column prop="pd_type" :label="TEXT.common.fields.pdType" show-overflow-tooltip />
@@ -455,6 +450,7 @@ const detail = reactive<any>({
   screening_date: "",
   consent_date: "",
   enrollment_date: "",
+  baseline_date: "",
   completion_date: "",
   drop_reason: "",
 });
@@ -464,6 +460,7 @@ const subjectSaving = ref(false);
 const subjectForm = reactive({
   status: "SCREENING",
   enrollment_date: "",
+  baseline_date: "",
   consent_date: "",
   completion_date: "",
   drop_reason: "",
@@ -615,6 +612,7 @@ const startSubjectEdit = () => {
   subjectForm.status = detail.status || "SCREENING";
   subjectForm.consent_date = detail.consent_date || "";
   subjectForm.enrollment_date = detail.enrollment_date || "";
+  subjectForm.baseline_date = detail.baseline_date || "";
   subjectForm.completion_date = detail.completion_date || "";
   subjectForm.drop_reason = detail.drop_reason || "";
   subjectEditing.value = true;
@@ -636,13 +634,15 @@ const saveSubjectEdit = async () => {
       status: subjectForm.status || null,
       consent_date: subjectForm.consent_date || null,
       enrollment_date: subjectForm.enrollment_date || null,
+      baseline_date: subjectForm.baseline_date || null,
       completion_date: subjectForm.completion_date || null,
       drop_reason: subjectForm.drop_reason || null,
     };
     await updateSubject(studyId, subjectId, payload);
     ElMessage.success(TEXT.common.messages.saveSuccess);
     subjectEditing.value = false;
-    loadSubject();
+    await loadSubject();
+    await loadVisits();
   } catch (e: any) {
     ElMessage.error(e?.response?.data?.message || TEXT.common.messages.saveFailed);
   } finally {
@@ -720,15 +720,7 @@ const loadVisits = async () => {
   try {
     const { data } = (await fetchVisits(studyId, subjectId)) as any;
     const items = Array.isArray(data) ? data : data.items || [];
-    visitItems.value = items.sort((a: any, b: any) => {
-      const getNum = (code: any) => {
-        const text = String(code || "");
-        if (!text.startsWith("V")) return Number.POSITIVE_INFINITY;
-        const num = Number(text.slice(1));
-        return Number.isFinite(num) ? num : Number.POSITIVE_INFINITY;
-      };
-      return getNum(a?.visit_code) - getNum(b?.visit_code);
-    });
+    visitItems.value = items;
   } catch (e: any) {
     ElMessage.error(e?.response?.data?.message || TEXT.common.messages.loadFailed);
   } finally {
@@ -1036,6 +1028,20 @@ const openPdDialog = (row?: any) => {
   pdDialogVisible.value = true;
 };
 
+const currentTabAction = computed(() => {
+  switch (activeTab.value) {
+    case "visits":
+      return { label: TEXT.common.actions.newVisit, onClick: () => openVisitDialog() };
+    case "ae":
+      return { label: TEXT.common.actions.newAe, onClick: () => openAeDialog() };
+    case "pd":
+      return { label: TEXT.modules.subjectDetail.newPd, onClick: () => openPdDialog() };
+    case "history":
+    default:
+      return { label: TEXT.common.actions.newHistory, onClick: () => openHistoryDialog() };
+  }
+});
+
 const savePd = async () => {
   if (isReadOnly.value) {
     ElMessage.warning("中心已停用");
@@ -1123,6 +1129,68 @@ onMounted(async () => {
   padding: 0;
 }
 
+.subject-tabs-shell {
+  margin-top: 12px;
+  border-top: 8px solid #f3f6fb;
+}
+
+.subject-tabs-shell {
+  position: relative;
+}
+
+.subject-tabs-shell :deep(.el-tabs__header) {
+  margin: 0;
+  padding: 0 160px 0 0;
+  background: #ffffff;
+  border-top: 1px solid #e5edf6;
+  border-bottom: 1px solid #e5edf6;
+}
+
+.subject-tabs-shell :deep(.el-tabs__nav-wrap) {
+  padding-left: 0;
+}
+
+.subject-tabs-shell :deep(.el-tabs__item) {
+  height: 48px;
+  line-height: 48px;
+  font-weight: 700;
+}
+
+.subject-tabs-shell :deep(.el-tabs__content) {
+  padding-top: 0;
+  background: #ffffff;
+}
+
+.subject-tabs-action {
+  position: absolute;
+  top: 8px;
+  right: 0;
+  z-index: 2;
+  display: flex;
+  align-items: center;
+}
+
+.subject-overview-descriptions :deep(.el-descriptions__table) {
+  table-layout: fixed;
+}
+
+.subject-overview-descriptions :deep(.el-descriptions__label) {
+  width: 140px;
+  min-width: 140px;
+  color: #344258;
+  font-weight: 700;
+}
+
+.subject-overview-descriptions :deep(.el-descriptions__content) {
+  width: calc(50% - 140px);
+  min-width: 0;
+}
+
+.subject-overview-descriptions :deep(.el-descriptions__cell) {
+  height: 42px;
+  vertical-align: middle;
+}
+
 .page-title {
   margin: 0;
   font-size: 22px;
@@ -1140,12 +1208,6 @@ onMounted(async () => {
   gap: 8px;
 }
 
-.tab-actions {
-  display: flex;
-  justify-content: flex-end;
-  margin-bottom: 10px;
-}
-
 .subject-detail-table :deep(.el-table__inner-wrapper::before) {
   display: none;
 }

frontend/src/views/subjects/SubjectForm.vue

@@ -1,86 +1,120 @@
 <template>
-  <div class="page">
-    <div class="page-header unified-action-bar">
-      <div>
-        <h1 class="page-title">{{ isEdit ? TEXT.modules.subjectForm.titleEdit : TEXT.modules.subjectForm.titleNew }}</h1>
-        <p class="page-subtitle">{{ TEXT.modules.subjectForm.subtitle }}</p>
-      </div>
-      <el-button @click="goBack">{{ TEXT.common.actions.back }}</el-button>
-    </div>
+  <div class="page subject-form-page">
+    <el-card class="unified-shell subject-form-shell">
+      <el-form :model="form" label-position="top" class="subject-form">
+        <div class="form-layout">
+          <section class="form-section form-section-primary">
+            <div class="section-heading">
+              <span class="section-kicker">Subject</span>
+              <h2>参与者标识</h2>
+            </div>
+            <div class="field-grid">
+              <el-form-item :label="TEXT.modules.subjectManagement.screeningNo" required class="field-span-2">
+                <el-input
+                  v-model="form.subject_no"
+                  :disabled="isEdit || isReadOnly"
+                  :placeholder="TEXT.common.placeholders.input + TEXT.modules.subjectManagement.screeningNo"
+                  size="large"
+                />
+              </el-form-item>
+              <el-form-item :label="TEXT.common.fields.site" required class="field-span-2">
+                <el-select v-model="form.site_id" :disabled="isEdit || isReadOnly" :placeholder="TEXT.common.placeholders.select" size="large">
+                  <el-option v-for="site in sites" :key="site.id" :label="site.name" :value="site.id" :disabled="!site.is_active" />
+                </el-select>
+              </el-form-item>
+              <el-form-item v-if="isEdit" :label="TEXT.common.fields.status" class="field-span-2">
+                <el-select v-model="form.status" :placeholder="TEXT.common.placeholders.select" :disabled="isReadOnly" size="large">
+                  <el-option :label="TEXT.enums.subjectStatus.SCREENING" value="SCREENING" />
+                  <el-option :label="TEXT.enums.subjectStatus.ENROLLED" value="ENROLLED" />
+                  <el-option :label="TEXT.enums.subjectStatus.COMPLETED" value="COMPLETED" />
+                  <el-option :label="TEXT.enums.subjectStatus.DROPPED" value="DROPPED" />
+                </el-select>
+              </el-form-item>
+            </div>
+          </section>
 
-    <el-card class="unified-shell">
-      <el-form :model="form" label-width="120px">
-        <el-form-item :label="TEXT.modules.subjectManagement.screeningNo" required>
-          <el-input
-            v-model="form.subject_no"
-            :disabled="isEdit || isReadOnly"
-            :placeholder="TEXT.common.placeholders.input + TEXT.modules.subjectManagement.screeningNo"
-          />
-        </el-form-item>
-        <el-form-item :label="TEXT.common.fields.site" required>
-          <el-select v-model="form.site_id" :disabled="isEdit || isReadOnly" :placeholder="TEXT.common.placeholders.select">
-            <el-option v-for="site in sites" :key="site.id" :label="site.name" :value="site.id" :disabled="!site.is_active" />
-          </el-select>
-        </el-form-item>
-        <el-form-item :label="TEXT.common.fields.screeningDate">
-          <el-date-picker
-            v-model="form.screening_date"
-            type="date"
-            value-format="YYYY-MM-DD"
-            :placeholder="TEXT.common.placeholders.select"
-            :disabled="isEdit || isReadOnly"
-          />
-        </el-form-item>
-        <el-form-item :label="TEXT.common.fields.consentDate">
-          <el-date-picker
-            v-model="form.consent_date"
-            type="date"
-            value-format="YYYY-MM-DD"
-            :placeholder="TEXT.common.placeholders.select"
-            :disabled="isReadOnly"
-          />
-        </el-form-item>
-        <el-form-item v-if="isEdit" :label="TEXT.common.fields.status">
-          <el-select v-model="form.status" :placeholder="TEXT.common.placeholders.select" :disabled="isReadOnly">
-            <el-option :label="TEXT.enums.subjectStatus.SCREENING" value="SCREENING" />
-            <el-option :label="TEXT.enums.subjectStatus.ENROLLED" value="ENROLLED" />
-            <el-option :label="TEXT.enums.subjectStatus.COMPLETED" value="COMPLETED" />
-            <el-option :label="TEXT.enums.subjectStatus.DROPPED" value="DROPPED" />
-          </el-select>
-        </el-form-item>
-        <el-form-item v-if="isEdit" :label="TEXT.common.fields.enrollmentDate">
-          <el-date-picker
-            v-model="form.enrollment_date"
-            type="date"
-            value-format="YYYY-MM-DD"
-            :placeholder="TEXT.common.placeholders.select"
-            :disabled="isReadOnly"
-          />
-        </el-form-item>
-        <el-form-item v-if="isEdit" :label="TEXT.common.fields.completionDate">
-          <el-date-picker
-            v-model="form.completion_date"
-            type="date"
-            value-format="YYYY-MM-DD"
-            :placeholder="TEXT.common.placeholders.select"
-            :disabled="isReadOnly"
-          />
-        </el-form-item>
-        <el-form-item v-if="isEdit" :label="TEXT.common.fields.dropReason">
-          <el-input
-            v-model="form.drop_reason"
-            type="textarea"
-            :rows="3"
-            :placeholder="TEXT.common.placeholders.input"
-            :disabled="isReadOnly"
-          />
-        </el-form-item>
-        <el-form-item>
-          <el-button type="primary" :loading="saving" :disabled="isReadOnly" @click="submit">
+          <section class="form-section">
+            <div class="section-heading">
+              <span class="section-kicker">Timeline</span>
+              <h2>关键日期</h2>
+            </div>
+            <div class="field-grid date-grid">
+              <el-form-item :label="TEXT.common.fields.screeningDate">
+                <el-date-picker
+                  v-model="form.screening_date"
+                  type="date"
+                  value-format="YYYY-MM-DD"
+                  :placeholder="TEXT.common.placeholders.select"
+                  :disabled="isEdit || isReadOnly"
+                  size="large"
+                />
+              </el-form-item>
+              <el-form-item :label="TEXT.common.fields.consentDate">
+                <el-date-picker
+                  v-model="form.consent_date"
+                  type="date"
+                  value-format="YYYY-MM-DD"
+                  :placeholder="TEXT.common.placeholders.select"
+                  :disabled="isReadOnly"
+                  size="large"
+                />
+              </el-form-item>
+              <el-form-item :label="TEXT.common.fields.enrollmentDate">
+                <el-date-picker
+                  v-model="form.enrollment_date"
+                  type="date"
+                  value-format="YYYY-MM-DD"
+                  :placeholder="TEXT.common.placeholders.select"
+                  :disabled="isReadOnly"
+                  size="large"
+                />
+              </el-form-item>
+              <el-form-item :label="TEXT.common.fields.baselineDate">
+                <el-date-picker
+                  v-model="form.baseline_date"
+                  type="date"
+                  value-format="YYYY-MM-DD"
+                  :placeholder="TEXT.common.placeholders.select"
+                  :disabled="isReadOnly"
+                  size="large"
+                />
+              </el-form-item>
+              <el-form-item v-if="isEdit" :label="TEXT.common.fields.completionDate">
+                <el-date-picker
+                  v-model="form.completion_date"
+                  type="date"
+                  value-format="YYYY-MM-DD"
+                  :placeholder="TEXT.common.placeholders.select"
+                  :disabled="isReadOnly"
+                  size="large"
+                />
+              </el-form-item>
+            </div>
+          </section>
+
+          <section v-if="isEdit" class="form-section field-span-all">
+            <div class="section-heading compact-heading">
+              <span class="section-kicker">Status</span>
+              <h2>退出信息</h2>
+            </div>
+            <el-form-item :label="TEXT.common.fields.dropReason">
+              <el-input
+                v-model="form.drop_reason"
+                type="textarea"
+                :rows="3"
+                :placeholder="TEXT.common.placeholders.input"
+                :disabled="isReadOnly"
+              />
+            </el-form-item>
+          </section>
+        </div>
+
+        <div class="form-actions">
+          <el-button class="form-cancel-btn" @click="goBack">{{ TEXT.common.actions.cancel }}</el-button>
+          <el-button type="primary" class="form-submit-btn" :loading="saving" :disabled="isReadOnly" @click="submit">
             {{ TEXT.common.actions.save }}
           </el-button>
-          <el-button @click="goBack">{{ TEXT.common.actions.cancel }}</el-button>
-        </el-form-item>
+        </div>
       </el-form>
     </el-card>
   </div>
@@ -120,6 +154,7 @@ const form = reactive({
   consent_date: "",
   status: "SCREENING",
   enrollment_date: "",
+  baseline_date: "",
   completion_date: "",
   drop_reason: "",
 });
@@ -145,6 +180,7 @@ const load = async () => {
       consent_date: data.consent_date || "",
       status: data.status || "SCREENING",
       enrollment_date: data.enrollment_date || "",
+      baseline_date: data.baseline_date || "",
       completion_date: data.completion_date || "",
       drop_reason: data.drop_reason || "",
     });
@@ -166,6 +202,7 @@ const submit = async () => {
         status: form.status || null,
         consent_date: form.consent_date || null,
         enrollment_date: form.enrollment_date || null,
+        baseline_date: form.baseline_date || null,
         completion_date: form.completion_date || null,
         drop_reason: form.drop_reason || null,
       };
@@ -178,6 +215,8 @@ const submit = async () => {
         site_id: form.site_id,
         screening_date: form.screening_date || null,
         consent_date: form.consent_date || null,
+        enrollment_date: form.enrollment_date || null,
+        baseline_date: form.baseline_date || null,
       };
       const { data } = await createSubject(studyId.value, payload);
       ElMessage.success(TEXT.common.messages.createSuccess);
@@ -199,27 +238,164 @@ onMounted(async () => {
 </script>
 
 <style scoped>
-.page {
+.subject-form-page {
   display: flex;
   flex-direction: column;
   gap: 16px;
 }
 
-.page-header {
+.subject-form-shell {
+  overflow: hidden;
+  border: 1px solid #e5edf6;
+  border-radius: 18px;
+  box-shadow: 0 18px 40px rgba(15, 23, 42, 0.05);
+}
+
+.subject-form-shell :deep(.el-card__body) {
+  padding: 0;
+}
+
+.subject-form {
+  background: #ffffff;
+}
+
+.form-layout {
+  display: grid;
+  grid-template-columns: minmax(320px, 0.78fr) minmax(420px, 1.22fr);
+  gap: 0;
+}
+
+.form-section {
+  padding: 26px 28px 22px;
+  border-bottom: 1px solid #edf2f7;
+}
+
+.form-section-primary {
+  border-right: 1px solid #edf2f7;
+  background: linear-gradient(180deg, #f8fbff 0%, #ffffff 72%);
+}
+
+.field-span-all {
+  grid-column: 1 / -1;
+}
+
+.section-heading {
   display: flex;
-  justify-content: space-between;
-  align-items: flex-end;
+  flex-direction: column;
+  gap: 4px;
+  margin-bottom: 18px;
 }
 
-.page-title {
+.compact-heading {
+  margin-bottom: 12px;
+}
+
+.section-kicker {
+  color: #3b82f6;
+  font-size: 12px;
+  font-weight: 800;
+  letter-spacing: 0.04em;
+  text-transform: uppercase;
+}
+
+.section-heading h2 {
   margin: 0;
-  font-size: 22px;
-  font-weight: 600;
+  color: #102033;
+  font-size: 17px;
+  font-weight: 800;
 }
 
-.page-subtitle {
-  margin: 6px 0 0;
+.field-grid {
+  display: grid;
+  grid-template-columns: repeat(2, minmax(0, 1fr));
+  gap: 16px 18px;
+}
+
+.date-grid {
+  align-items: start;
+}
+
+.field-span-2 {
+  grid-column: 1 / -1;
+}
+
+.subject-form :deep(.el-form-item) {
+  margin-bottom: 0;
+}
+
+.subject-form :deep(.el-form-item__label) {
+  margin-bottom: 7px;
+  color: #53657f;
   font-size: 13px;
-  color: var(--ctms-text-secondary);
+  font-weight: 750;
+  line-height: 1.2;
+}
+
+.subject-form :deep(.el-input__wrapper),
+.subject-form :deep(.el-select__wrapper) {
+  min-height: 44px;
+  border-radius: 12px;
+  box-shadow: 0 0 0 1px #dfe7f1 inset;
+  transition: box-shadow 0.16s ease, background-color 0.16s ease;
+}
+
+.subject-form :deep(.el-input__wrapper:hover),
+.subject-form :deep(.el-select__wrapper:hover) {
+  box-shadow: 0 0 0 1px #b8c8dc inset;
+}
+
+.subject-form :deep(.el-input__wrapper.is-focus),
+.subject-form :deep(.el-select__wrapper.is-focused) {
+  box-shadow: 0 0 0 1px #3b82f6 inset, 0 0 0 3px rgba(59, 130, 246, 0.12);
+}
+
+.subject-form :deep(.el-date-editor),
+.subject-form :deep(.el-select),
+.subject-form :deep(.el-input) {
+  width: 100%;
+}
+
+.form-actions {
+  position: sticky;
+  bottom: 0;
+  z-index: 1;
+  display: flex;
+  justify-content: flex-end;
+  gap: 10px;
+  padding: 16px 28px;
+  border-top: 1px solid #e5edf6;
+  background: rgba(255, 255, 255, 0.94);
+  backdrop-filter: blur(10px);
+}
+
+.form-submit-btn,
+.form-cancel-btn {
+  min-width: 88px;
+  height: 40px;
+  border-radius: 12px;
+  font-weight: 800;
+}
+
+.form-submit-btn {
+  background: #415b76;
+  border-color: #415b76;
+}
+
+@media (max-width: 960px) {
+  .form-layout {
+    grid-template-columns: 1fr;
+  }
+
+  .form-section-primary {
+    border-right: none;
+  }
+
+  .field-grid {
+    grid-template-columns: 1fr;
+  }
+
+  .form-actions {
+    padding: 14px 18px;
+  }
 }
 </style>