Files
ctms/backend/app/models/ae.py
T
2026-02-24 16:53:22 +08:00

38 lines
2.3 KiB
Python

import uuid
from datetime import datetime, date
from sqlalchemy import Boolean, 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 AdverseEvent(Base):
__tablename__ = "adverse_events"
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 | None] = mapped_column(UUID(as_uuid=True), ForeignKey("sites.id"), index=True, nullable=True)
subject_id: Mapped[uuid.UUID | None] = mapped_column(UUID(as_uuid=True), ForeignKey("subjects.id"), index=True, nullable=True)
visit_id: Mapped[uuid.UUID | None] = mapped_column(UUID(as_uuid=True), nullable=True)
term: Mapped[str] = mapped_column(String(255), nullable=False)
onset_date: Mapped[date | None] = mapped_column(Date, nullable=True)
resolution_date: Mapped[date | None] = mapped_column(Date, nullable=True)
seriousness: Mapped[str] = mapped_column(String(50), nullable=False)
severity: Mapped[str] = mapped_column(String(50), nullable=False)
causality: Mapped[str | None] = mapped_column(String(50), nullable=True)
action_taken: Mapped[str | None] = mapped_column(Text, nullable=True)
outcome: Mapped[str | None] = mapped_column(String(50), nullable=True)
reported_to_sponsor: Mapped[bool] = mapped_column(Boolean, nullable=False, default=False)
is_sae: Mapped[bool] = mapped_column(Boolean, nullable=False, default=False)
is_susar: Mapped[bool] = mapped_column(Boolean, nullable=False, default=False)
report_due_date: Mapped[date | None] = mapped_column(Date, nullable=True)
status: Mapped[str] = mapped_column(String(20), nullable=False, default="NEW")
description: Mapped[str | None] = mapped_column(Text, nullable=True)
created_by: Mapped[uuid.UUID] = mapped_column(UUID(as_uuid=True), ForeignKey("users.id"), nullable=False)
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()
)