United States Core Data for Interoperability (USCDI+) Seeks Feedback on Adverse Event Data Elements

November 7, 2024

If you’re conducting immunotherapy studies and reporting adverse events, the USCDI+ Cancer program staff need to hear from you!

NCI, the Assistant Secretary for Technology Policy/Office of the National Coordinator for Health Information Technology and the U.S. Food and Drug Administration have released the USCDI+ Cancer Immune-related Adverse Events (irAE) draft data set.

Capturing adverse events is a vital part of cancer clinical trials. If researchers don’t record these events in a timely and complete way, it can lead to outcomes that could be deadly.

The irAE draft data set should help standardize this reporting.

To submit your comments, visit the USCDI+ Platform. Don’t delay! The public comment period ends January 10, 2025.

[callout]Watch the recent USCDI+ Cancer Public Listening Session and flip through the slides to learn more about establishing and refining standardized structured data elements.[/callout]

Help make sure USCDI+’s elements capture the information you need to address your research needs. In particular, do you think the data set:

• is complete and relevant for detecting and reporting immune-related adverse events?
• addresses key data standards, codes, and terms?
• presents challenges for collecting and sharing the data electronically?

This is your opportunity to give feedback on these key cancer data elements, which will be part of many patients’ electronic heath records. The data elements also will help you use language models to mine for data on adverse events.

Need help or have a question? You can learn more about the public comment process by contacting USCDI.plus@hhs.gov.