Common data elements (CDEs) are standardized, precisely defined questions paired with a set of specific allowable responses, used systematically across different sites, studies, or clinical trials to ensure consistent data collection. NIH plans to establish a minimum core set of CDEs for use in all clinical studies and trials supported or conducted with NIH funding.
Through Request for Information (RFI): Proposed Use of Common Data Elements (CDEs) for NIH-Funded Clinical Research and Trials, NIH invites community feedback on upcoming efforts to develop and implement a set of minimum core CDEs, as well as related technologies, tools, guidance, challenges, and opportunities.
Information Requested
Specifically, NIH seeks comments on the following topics:
Recommended CDEs for NIH-funded clinical research/trials—NIH seeks comments on a set of minimum core CDEs in the demographics/personal characteristics category. NIH also seeks comments on recommended CDEs in clinical domains including autoimmune diseases and immune-mediated diseases, and high-level CDEs for the social determinants of health domain. Could any alternative approaches help determine a set of minimum core CDEs?
Technology standards for using NIH CDEs—NIH seeks broad input on tools and technologies that could enhance the use of NIH CDEs. NIH CDEs are defined as CDEs “recommended” or “required” by an NIH body or found in the NIH CDE Repository. What tools and processes could assist in data transformation and mapping?
NIH policies and governance on CDEs—NIH seeks input on policies and governance that could facilitate and incentivize broader CDE usage in research and in data sharing and management. What potential difficulties or obstacles do you foresee in adopting minimum core CDEs?
The RFI itself provides longer explanations of the key discussion points within each of those topics.
Submitting a Response
You can submit a response by filling out the webform at RFI: Proposed Use of Common Data Elements (CDEs) for NIH-Funded Clinical Research and Trials or emailing a PDF response to cde-rfi@od.nih.gov. The deadline to reply is 11:59 p.m. Eastern Time on April 20, 2024.
NIH encourages feedback on behalf of professional organizations as well.
Contact Dr. Belinda Seto at cde-rfi@od.nih.gov if you have any questions.
Responses to this RFI are voluntary and may be submitted anonymously. If you include your name and contact information, know that NIH will not share those details outside of NIH unless required by law.