Wednesday, February 24, 2021
Responses due May 10, 2021
The National Library of Medicine (NLM) recently released a Request for Information (NOT-LM-21-005) on the use of Common Data Elements (CDEs) in research funded by the National Institutes of Health (NIH). NLM is especially interested in the use of CDEs in the context of research on COVID-19, including opportunities for advancing research with CDEs, challenges to adopting CDEs, and guidance or tools that could facilitate use of CDEs. These comments will be used to inform NIH’s continuing development of guidance on CDE use for COVID-related research. Responses are due May 10.
About Common Data Elements (CDEs)
CDEs are standardized, precisely defined questions paired with a set of specific allowable responses that are used systematically across different sites, studies, or clinical trials to ensure consistent data collection. CDEs may consist of a single data element—such as height, gender, or date of birth—or a collection of connected questions, such as a survey instrument used as a depression index or a quality of life scale. For more than a decade, the NIH has encouraged the use and development of CDEs in patient registries, clinical studies, and other human subjects research.
Using CDEs fosters rigor and responsibility in research and reuse of properly consented data for future research projects. Collecting data with CDEs facilitates data sharing and interoperability, enabling integration and meta-analysis of data across multiple studies. CDEs can also help improve data quality and enhance research reproducibility, enable data harmonization across studies, and increase the “FAIRness” of data – the extent to which they are findable, accessible, interoperable, and reusable.
In the context of COVID-19 research, using CDEs to describe study participants can help ensure that data are collected consistently across multiple sites and studies. Given the urgent need to develop new vaccines and therapeutics, design tools for rapid diagnosis, and understand the health impacts of COVID-19, CDEs are an important tool for collecting data in systematic and consistent ways to facilitate their use and reuse.
To respond to this RFI, please submit your response via this webform. To ensure consideration, responses must be submitted by May 10, 2021. Names need not be associated with responses; responses are voluntary and may be submitted anonymously.
Read the “Open Mike” blog post on this opportunity.
