Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE®)

This site was designed to provide you with information about PRO-CTCAE®, a patient-reported outcome measurement system developed by the National Cancer Institute to capture symptomatic adverse events in patients on cancer clinical trials. The availability of PRO-CTCAE in more than 60 validated languages supports the inclusion of culturally and linguistically diverse populations in cancer clinical trials and addresses language-related barriers to the equitable participation of underrepresented groups.

More About PRO-CTCAE
PRO-CTCAE FAQs and Resources
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Announcements

  • We have recently finalized a set of data standards for PRO-CTCAE. More information about these standards, which were developed in collaboration with Clinical Data Interchange Standards Consortium (CDISC) and the US FDA, is available on the CDISC website and at our website PRO-CTCAE Frequently Asked Questions.
  • The Ped-PRO-CTCAE module has now been validated in additional languages, including French and Dutch, broadening our capacity to collect symptomatic adverse events by self-report in pediatric cancer clinical trials.

Measurement System

The National Cancer Institute’s PRO-CTCAE Measurement System was developed to capture symptomatic toxicity by self-report in adults, children and adolescents participating in cancer clinical trials.

Instruments & Form Builder

Download the full instruments, preview the item libraries using the Quick Guides, or use our Form Builders to produce a custom survey in any available language for your study.

Frequently Asked Questions and Resources

If you have questions about the PRO-CTCAE Measurement System, please read the FAQ section.

Release Notes

Release notes highlight any changes, updates or corrections made to PRO-CTCAE Item Libraries.

Resources

Last Updated: 05 Jun, 2025