Serious Adverse Events

All serious adverse events are adverse events, but not all adverse events are serious adverse events (SAEs). Adverse events need to be reported as SAEs only if they meet the guidelines for expedited reporting in Section 16 or Section 8 of the protocol. Timely reporting of serious adverse events and adverse drug reactions in clinical trials is required by Food and Drug Administration regulations and policies of both the National Cancer Institute and SWOG Cancer Research Network. Such reporting improves both patient care and scientific communication by allowing rapid dissemination of new findings to other investigators studying the drug. Below are links and tools to assist in this important process.

Serious Adverse Event - Expedited Reporting

• Cancer Therapy Evaluation Program Adverse Event Reporting System (CTEP-AERS)
  • CTEP-AERS Application
  • CTEP-AERS Help Page - This page includes an information guide, training presentations, link to computer-based training.
• NCI Guidelines - Adverse Event Reporting
  • NCI Guidelines for Investigators: Adverse Event Reporting Requirements for DCTD (CTEP and CIP) INDs and IDEs (August 30, 2024)

If you have any questions regarding Serious Adverse Event reporting, the CTEP-AERS reporting system, or the RAVE/CTEP-AERS integration, please contact the SWOG SAE Team at adr@swog.org or 210-614-8808.

If you would like to check whether an AE requires SAE reporting, please do not hesitate to contact us - that is exactly what we are here for.