Safety Operations Clinical Safety

Clinical Safety — Case Workspaces

Review clinical cases →

Clinical case paths

Import a source, then continue its existing review, approval and XML export workflow.

Intake + source

SAE Form

Receive and process study-linked serious adverse event cases from supported clinical source forms.

Accepted sources

  • Clinical SAE form PDF or text
  • CIOMS I PDF or text
  • FDA MedWatch 3500A PDF or text
SAE Review Queue