diff --git a/backend/app/api/v1/router.py b/backend/app/api/v1/router.py
index de9cf9a6..3f31c27b 100644
--- a/backend/app/api/v1/router.py
+++ b/backend/app/api/v1/router.py
@@ -1,6 +1,6 @@
 from fastapi import APIRouter
 
-from app.api.v1 import auth, users, studies, sites, members, comments, attachments, audit_logs, milestones, tasks, dashboard
+from app.api.v1 import auth, users, studies, sites, members, comments, attachments, audit_logs, milestones, tasks, dashboard, subjects, visits
 
 api_router = APIRouter()
 api_router.include_router(auth.router, prefix="/auth", tags=["auth"])
@@ -14,3 +14,5 @@ api_router.include_router(audit_logs.router, prefix="/studies/{study_id}/audit-l
 api_router.include_router(milestones.router, prefix="/studies/{study_id}/milestones", tags=["milestones"])
 api_router.include_router(tasks.router, prefix="/studies/{study_id}/tasks", tags=["tasks"])
 api_router.include_router(dashboard.router, prefix="/studies/{study_id}/dashboard", tags=["dashboard"])
+api_router.include_router(subjects.router, prefix="/studies/{study_id}/subjects", tags=["subjects"])
+api_router.include_router(visits.router, prefix="/studies/{study_id}/subjects/{subject_id}/visits", tags=["visits"])
diff --git a/backend/app/api/v1/subjects.py b/backend/app/api/v1/subjects.py
new file mode 100644
index 00000000..fb832180
--- /dev/null
+++ b/backend/app/api/v1/subjects.py
@@ -0,0 +1,102 @@
+import uuid
+
+from fastapi import APIRouter, Depends, HTTPException, status
+from sqlalchemy.ext.asyncio import AsyncSession
+
+from app.core.deps import get_current_user, get_db_session, require_study_member, require_study_roles
+from app.crud import audit as audit_crud
+from app.crud import subject as subject_crud
+from app.crud import study as study_crud
+from app.schemas.subject import SubjectCreate, SubjectRead, SubjectUpdate
+
+router = APIRouter()
+
+
+async def _ensure_study_exists(db: AsyncSession, study_id: uuid.UUID):
+    study = await study_crud.get(db, study_id)
+    if not study:
+        raise HTTPException(status_code=status.HTTP_404_NOT_FOUND, detail="Study not found")
+    return study
+
+
+@router.post(
+    "/",
+    response_model=SubjectRead,
+    status_code=status.HTTP_201_CREATED,
+    dependencies=[Depends(require_study_roles(["PM", "CRA"]))],
+)
+async def create_subject(
+    study_id: uuid.UUID,
+    subject_in: SubjectCreate,
+    db: AsyncSession = Depends(get_db_session),
+    current_user=Depends(get_current_user),
+) -> SubjectRead:
+    await _ensure_study_exists(db, study_id)
+    try:
+        subject = await subject_crud.create_subject(db, study_id, subject_in)
+    except ValueError as exc:
+        raise HTTPException(status_code=status.HTTP_400_BAD_REQUEST, detail=str(exc)) from exc
+    await audit_crud.log_action(
+        db,
+        study_id=study_id,
+        entity_type="subject",
+        entity_id=subject.id,
+        action="CREATE_SUBJECT",
+        detail=f"Subject {subject.subject_no} created",
+        operator_id=current_user.id,
+        operator_role=current_user.role,
+    )
+    return subject
+
+
+@router.get(
+    "/",
+    response_model=list[SubjectRead],
+    dependencies=[Depends(require_study_member())],
+)
+async def list_subjects(
+    study_id: uuid.UUID,
+    site_id: uuid.UUID | None = None,
+    status_filter: str | None = None,
+    db: AsyncSession = Depends(get_db_session),
+) -> list[SubjectRead]:
+    await _ensure_study_exists(db, study_id)
+    subjects = await subject_crud.list_subjects(db, study_id, site_id=site_id, status=status_filter)
+    return list(subjects)
+
+
+@router.patch(
+    "/{subject_id}",
+    response_model=SubjectRead,
+    dependencies=[Depends(require_study_roles(["PM", "CRA"]))],
+)
+async def update_subject(
+    study_id: uuid.UUID,
+    subject_id: uuid.UUID,
+    subject_in: SubjectUpdate,
+    db: AsyncSession = Depends(get_db_session),
+    current_user=Depends(get_current_user),
+) -> SubjectRead:
+    await _ensure_study_exists(db, study_id)
+    subject = await subject_crud.get_subject(db, subject_id)
+    if not subject or subject.study_id != study_id:
+        raise HTTPException(status_code=status.HTTP_404_NOT_FOUND, detail="Subject not found")
+    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)
+    detail = None
+    if subject_in.status and subject_in.status != old_status:
+        detail = f"subject {updated.subject_no} status {old_status} -> {subject_in.status}"
+    await audit_crud.log_action(
+        db,
+        study_id=study_id,
+        entity_type="subject",
+        entity_id=subject_id,
+        action="SUBJECT_STATUS_CHANGE" if detail else "UPDATE_SUBJECT",
+        detail=detail or "Subject updated",
+        operator_id=current_user.id,
+        operator_role=current_user.role,
+    )
+    return updated
diff --git a/backend/app/api/v1/visits.py b/backend/app/api/v1/visits.py
new file mode 100644
index 00000000..e38beeb6
--- /dev/null
+++ b/backend/app/api/v1/visits.py
@@ -0,0 +1,70 @@
+import uuid
+
+from fastapi import APIRouter, Depends, HTTPException, status
+from sqlalchemy.ext.asyncio import AsyncSession
+
+from app.core.deps import get_current_user, get_db_session, require_study_member, require_study_roles
+from app.crud import audit as audit_crud
+from app.crud import subject as subject_crud
+from app.crud import visit as visit_crud
+from app.schemas.visit import VisitRead, VisitUpdate
+
+router = APIRouter()
+
+
+async def _ensure_subject(db: AsyncSession, study_id: uuid.UUID, subject_id: uuid.UUID):
+    subject = await subject_crud.get_subject(db, subject_id)
+    if not subject or subject.study_id != study_id:
+        raise HTTPException(status_code=status.HTTP_404_NOT_FOUND, detail="Subject not found")
+    return subject
+
+
+@router.get(
+    "/",
+    response_model=list[VisitRead],
+    dependencies=[Depends(require_study_member())],
+)
+async def list_visits(
+    study_id: uuid.UUID,
+    subject_id: uuid.UUID,
+    db: AsyncSession = Depends(get_db_session),
+) -> list[VisitRead]:
+    await _ensure_subject(db, study_id, subject_id)
+    visits = await visit_crud.list_visits(db, subject_id)
+    return list(visits)
+
+
+@router.patch(
+    "/{visit_id}",
+    response_model=VisitRead,
+    dependencies=[Depends(require_study_roles(["PM", "CRA"]))],
+)
+async def update_visit(
+    study_id: uuid.UUID,
+    subject_id: uuid.UUID,
+    visit_id: uuid.UUID,
+    visit_in: VisitUpdate,
+    db: AsyncSession = Depends(get_db_session),
+    current_user=Depends(get_current_user),
+) -> VisitRead:
+    await _ensure_subject(db, study_id, subject_id)
+    visit = await visit_crud.get_visit(db, visit_id)
+    if not visit or visit.subject_id != subject_id or visit.study_id != study_id:
+        raise HTTPException(status_code=status.HTTP_404_NOT_FOUND, detail="Visit not found")
+    if visit_in.status == "DONE" and not visit_in.actual_date:
+        raise HTTPException(status_code=status.HTTP_400_BAD_REQUEST, detail="actual_date required when DONE")
+    updated = await visit_crud.update_visit(db, visit, visit_in)
+    detail = None
+    if visit_in.status:
+        detail = f"visit {visit.visit_code} {visit.status} -> {visit_in.status}"
+    await audit_crud.log_action(
+        db,
+        study_id=study_id,
+        entity_type="visit",
+        entity_id=visit_id,
+        action="VISIT_STATUS_CHANGE" if detail else "UPDATE_VISIT",
+        detail=detail or "Visit updated",
+        operator_id=current_user.id,
+        operator_role=current_user.role,
+    )
+    return updated
diff --git a/backend/app/crud/subject.py b/backend/app/crud/subject.py
new file mode 100644
index 00000000..b9ce3d2c
--- /dev/null
+++ b/backend/app/crud/subject.py
@@ -0,0 +1,104 @@
+import uuid
+from datetime import date, timedelta
+from typing import Sequence
+
+from sqlalchemy import select, update as sa_update
+from sqlalchemy.ext.asyncio import AsyncSession
+
+from app.crud import visit as visit_crud
+from app.models.site import Site
+from app.models.subject import Subject
+from app.schemas.subject import SubjectCreate, SubjectUpdate
+
+
+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()
+    if not site or site.study_id != study_id:
+        raise ValueError("Site not found in study")
+
+
+async def create_subject(db: AsyncSession, study_id: uuid.UUID, subject_in: SubjectCreate) -> Subject:
+    await _validate_site(db, study_id, subject_in.site_id)
+    subject = Subject(
+        study_id=study_id,
+        site_id=subject_in.site_id,
+        subject_no=subject_in.subject_no,
+        status="SCREENING",
+        screening_date=subject_in.screening_date,
+        enrollment_date=None,
+        completion_date=None,
+        drop_reason=None,
+    )
+    db.add(subject)
+    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",
+        visit_name="Screening",
+        planned_date=subject.screening_date,
+    )
+    return subject
+
+
+async def get_subject(db: AsyncSession, subject_id: uuid.UUID) -> Subject | None:
+    result = await db.execute(select(Subject).where(Subject.id == subject_id))
+    return result.scalar_one_or_none()
+
+
+async def list_subjects(
+    db: AsyncSession,
+    study_id: uuid.UUID,
+    site_id: uuid.UUID | None = None,
+    status: str | None = None,
+) -> Sequence[Subject]:
+    stmt = select(Subject).where(Subject.study_id == study_id)
+    if site_id:
+        stmt = stmt.where(Subject.site_id == site_id)
+    if status:
+        stmt = stmt.where(Subject.status == status)
+    result = await db.execute(stmt)
+    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
+    baseline_date = subject.enrollment_date
+    follow1 = baseline_date + timedelta(days=30)
+    follow2 = baseline_date + timedelta(days=60)
+    visits_data = [
+        ("V1", "Baseline", baseline_date),
+        ("FU1", "Follow-up 1", follow1),
+        ("FU2", "Follow-up 2", follow2),
+    ]
+    for code, name, plan_date in visits_data:
+        await visit_crud.create_visit(
+            db,
+            study_id=subject.study_id,
+            visit_in=None,
+            subject=subject,
+            visit_code=code,
+            visit_name=name,
+            planned_date=plan_date,
+        )
+
+
+async def update_subject(db: AsyncSession, subject: Subject, subject_in: SubjectUpdate) -> Subject:
+    update_data = subject_in.model_dump(exclude_unset=True)
+    if update_data:
+        await db.execute(
+            sa_update(Subject)
+            .where(Subject.id == subject.id)
+            .values(**update_data)
+        )
+        await db.commit()
+    await db.refresh(subject)
+    return subject
diff --git a/backend/app/crud/visit.py b/backend/app/crud/visit.py
new file mode 100644
index 00000000..8d6f55ac
--- /dev/null
+++ b/backend/app/crud/visit.py
@@ -0,0 +1,60 @@
+import uuid
+from typing import Sequence
+
+from sqlalchemy import select, update as sa_update
+from sqlalchemy.ext.asyncio import AsyncSession
+
+from app.models.subject import Subject
+from app.models.visit import Visit
+from app.schemas.visit import VisitCreate, VisitUpdate
+
+
+async def create_visit(
+    db: AsyncSession,
+    *,
+    study_id: uuid.UUID,
+    visit_in: VisitCreate | None,
+    subject: Subject,
+    visit_code: str,
+    visit_name: str,
+    planned_date,
+) -> Visit:
+    visit = Visit(
+        study_id=study_id,
+        subject_id=subject.id,
+        visit_code=visit_code,
+        visit_name=visit_name,
+        planned_date=planned_date,
+        actual_date=None,
+        status="PLANNED",
+        window_start=visit_in.window_start if visit_in else None,
+        window_end=visit_in.window_end if visit_in else None,
+        notes=None,
+    )
+    db.add(visit)
+    await db.commit()
+    await db.refresh(visit)
+    return 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()
+
+
+async def get_visit(db: AsyncSession, visit_id: uuid.UUID) -> Visit | None:
+    result = await db.execute(select(Visit).where(Visit.id == visit_id))
+    return result.scalar_one_or_none()
+
+
+async def update_visit(db: AsyncSession, visit: Visit, visit_in: VisitUpdate) -> Visit:
+    update_data = visit_in.model_dump(exclude_unset=True)
+    if update_data:
+        await db.execute(
+            sa_update(Visit)
+            .where(Visit.id == visit.id)
+            .values(**update_data)
+        )
+        await db.commit()
+    await db.refresh(visit)
+    return visit
diff --git a/backend/app/db/base.py b/backend/app/db/base.py
index 71a6b635..6cafdf6c 100644
--- a/backend/app/db/base.py
+++ b/backend/app/db/base.py
@@ -10,3 +10,5 @@ from app.models.attachment import Attachment  # noqa: F401
 from app.models.audit_log import AuditLog  # noqa: F401
 from app.models.milestone import Milestone  # noqa: F401
 from app.models.task import Task  # noqa: F401
+from app.models.subject import Subject  # noqa: F401
+from app.models.visit import Visit  # noqa: F401
diff --git a/backend/app/models/subject.py b/backend/app/models/subject.py
new file mode 100644
index 00000000..86601a67
--- /dev/null
+++ b/backend/app/models/subject.py
@@ -0,0 +1,27 @@
+import uuid
+from datetime import datetime, date
+
+from sqlalchemy import Date, DateTime, ForeignKey, String, Text, UniqueConstraint, func
+from sqlalchemy.dialects.postgresql import UUID
+from sqlalchemy.orm import Mapped, mapped_column
+
+from app.db.base_class import Base
+
+
+class Subject(Base):
+    __tablename__ = "subjects"
+    __table_args__ = (UniqueConstraint("study_id", "subject_no", name="uq_subject_study_no"),)
+
+    id: Mapped[uuid.UUID] = mapped_column(UUID(as_uuid=True), primary_key=True, default=uuid.uuid4)
+    study_id: Mapped[uuid.UUID] = mapped_column(UUID(as_uuid=True), ForeignKey("studies.id"), index=True, nullable=False)
+    site_id: Mapped[uuid.UUID] = mapped_column(UUID(as_uuid=True), ForeignKey("sites.id"), index=True, nullable=False)
+    subject_no: Mapped[str] = mapped_column(String(50), nullable=False)
+    status: Mapped[str] = mapped_column(String(20), nullable=False, default="SCREENING")
+    screening_date: Mapped[date | None] = mapped_column(Date, nullable=True)
+    enrollment_date: Mapped[date | None] = mapped_column(Date, nullable=True)
+    completion_date: Mapped[date | None] = mapped_column(Date, nullable=True)
+    drop_reason: Mapped[str | None] = mapped_column(Text, nullable=True)
+    created_at: Mapped[datetime] = mapped_column(DateTime(timezone=True), nullable=False, server_default=func.now())
+    updated_at: Mapped[datetime] = mapped_column(
+        DateTime(timezone=True), nullable=False, server_default=func.now(), onupdate=func.now()
+    )
diff --git a/backend/app/models/visit.py b/backend/app/models/visit.py
new file mode 100644
index 00000000..305c3146
--- /dev/null
+++ b/backend/app/models/visit.py
@@ -0,0 +1,28 @@
+import uuid
+from datetime import datetime, date
+
+from sqlalchemy import Date, DateTime, ForeignKey, String, Text, func
+from sqlalchemy.dialects.postgresql import UUID
+from sqlalchemy.orm import Mapped, mapped_column
+
+from app.db.base_class import Base
+
+
+class Visit(Base):
+    __tablename__ = "visits"
+
+    id: Mapped[uuid.UUID] = mapped_column(UUID(as_uuid=True), primary_key=True, default=uuid.uuid4)
+    study_id: Mapped[uuid.UUID] = mapped_column(UUID(as_uuid=True), ForeignKey("studies.id"), nullable=False)
+    subject_id: Mapped[uuid.UUID] = mapped_column(UUID(as_uuid=True), ForeignKey("subjects.id"), index=True, nullable=False)
+    visit_code: Mapped[str] = mapped_column(String(50), nullable=False)
+    visit_name: Mapped[str] = mapped_column(String(200), nullable=False)
+    planned_date: Mapped[date | None] = mapped_column(Date, nullable=True)
+    actual_date: Mapped[date | None] = mapped_column(Date, nullable=True)
+    status: Mapped[str] = mapped_column(String(20), nullable=False, default="PLANNED")
+    window_start: Mapped[date | None] = mapped_column(Date, nullable=True)
+    window_end: Mapped[date | None] = mapped_column(Date, nullable=True)
+    notes: Mapped[str | None] = mapped_column(Text, nullable=True)
+    created_at: Mapped[datetime] = mapped_column(DateTime(timezone=True), nullable=False, server_default=func.now())
+    updated_at: Mapped[datetime] = mapped_column(
+        DateTime(timezone=True), nullable=False, server_default=func.now(), onupdate=func.now()
+    )
diff --git a/backend/app/schemas/subject.py b/backend/app/schemas/subject.py
new file mode 100644
index 00000000..2e690732
--- /dev/null
+++ b/backend/app/schemas/subject.py
@@ -0,0 +1,34 @@
+import uuid
+from datetime import date, datetime
+from typing import Optional
+
+from pydantic import BaseModel, ConfigDict
+
+
+class SubjectCreate(BaseModel):
+    site_id: uuid.UUID
+    subject_no: str
+    screening_date: Optional[date] = None
+
+
+class SubjectUpdate(BaseModel):
+    status: Optional[str] = None
+    enrollment_date: Optional[date] = None
+    completion_date: Optional[date] = None
+    drop_reason: Optional[str] = None
+
+
+class SubjectRead(BaseModel):
+    id: uuid.UUID
+    study_id: uuid.UUID
+    site_id: uuid.UUID
+    subject_no: str
+    status: str
+    screening_date: Optional[date]
+    enrollment_date: Optional[date]
+    completion_date: Optional[date]
+    drop_reason: Optional[str]
+    created_at: datetime
+    updated_at: datetime
+
+    model_config = ConfigDict(from_attributes=True)
diff --git a/backend/app/schemas/visit.py b/backend/app/schemas/visit.py
new file mode 100644
index 00000000..f9170871
--- /dev/null
+++ b/backend/app/schemas/visit.py
@@ -0,0 +1,38 @@
+import uuid
+from datetime import date, datetime
+from typing import Optional
+
+from pydantic import BaseModel, ConfigDict
+
+
+class VisitCreate(BaseModel):
+    subject_id: uuid.UUID
+    visit_code: str
+    visit_name: str
+    planned_date: Optional[date] = None
+    window_start: Optional[date] = None
+    window_end: Optional[date] = None
+
+
+class VisitUpdate(BaseModel):
+    actual_date: Optional[date] = None
+    status: Optional[str] = None
+    notes: Optional[str] = None
+
+
+class VisitRead(BaseModel):
+    id: uuid.UUID
+    study_id: uuid.UUID
+    subject_id: uuid.UUID
+    visit_code: str
+    visit_name: str
+    planned_date: Optional[date]
+    actual_date: Optional[date]
+    status: str
+    window_start: Optional[date]
+    window_end: Optional[date]
+    notes: Optional[str]
+    created_at: datetime
+    updated_at: datetime
+
+    model_config = ConfigDict(from_attributes=True)
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