Files
ctms/backend/app/models/ae.py
T

41 lines
2.4 KiB
Python

from __future__ import annotations
from typing import Optional
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[Optional[uuid.UUID]] = mapped_column(UUID(as_uuid=True), ForeignKey("sites.id"), index=True, nullable=True)
subject_id: Mapped[Optional[uuid.UUID]] = mapped_column(UUID(as_uuid=True), ForeignKey("subjects.id"), index=True, nullable=True)
visit_id: Mapped[Optional[uuid.UUID]] = mapped_column(UUID(as_uuid=True), nullable=True)
term: Mapped[str] = mapped_column(String(255), nullable=False)
onset_date: Mapped[Optional[date]] = mapped_column(Date, nullable=True)
resolution_date: Mapped[Optional[date]] = 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[Optional[str]] = mapped_column(String(50), nullable=True)
action_taken: Mapped[Optional[str]] = mapped_column(Text, nullable=True)
outcome: Mapped[Optional[str]] = 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[Optional[date]] = mapped_column(Date, nullable=True)
status: Mapped[str] = mapped_column(String(20), nullable=False, default="FOLLOW_UP")
description: Mapped[Optional[str]] = 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()
)