Adverse Events/CTCAE

• Adverse Event Reporting Systems
  • CTEP-AERS: Cancer Therapy Evaluation Program Adverse Event Reporting System
• Adverse Event Reporting Guidance/Forms
  • NCI Guidelines for Investigators: Adverse Event Reporting Requirements for DCTD (CTEP and CIP) and DCP INDs and IDEs (PDF) (effective August 30, 2024)
  • Pregnancy Report Form (PDF) (effective August 30, 2024)
  • Guidance for SAE Reporting When an SAE Report is Initiated Outside the Rave/CTEP-AERS Integration on a Rave/CTEP-AERS Integrated Study (PDF)
  • CTEP/NCORP Guidance for Collection of Adverse Events Related to COVID-19 Infection (3/25/2020)
  • Non-animated Presentation on AE Reporting and Final Rule 3-28-2011 (suitable for printing) (MS PowerPoint)
  • Legacy Adverse Event Reporting Tables
• CTCAE: Common Terminology Criteria for Adverse Events
• Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)