CTEP Branches and Offices
Last Updated: 04/30/21
Adverse Events/CTCAE
- Adverse Event Reporting Systems
- Adverse Event Reporting Guidance/Forms
- 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)
- NCI Guidelines for Investigators: Adverse Event Reporting Requirements for DCTD (CTEP and CIP) and DCP INDs and IDEs (PDF)
- Pregnancy Report Form (PDF)
- Animated Presentation on AE Reporting and Final Rule 3-28-2011 (MS PowerPoint)
- Non-animated Presentation on AE Reporting and Final Rule 3-28-2011 (suitable for printing)
(MS PowerPoint)
- CTCAE: Common Terminology Criteria for Adverse Events
- Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)