Abstract Details

Title A Common Data Language for Clinical Research Studies: Overview and Update on the National Institute of Neurological Disorders and Stroke (NINDS) Common Data Element (CDE) Recommendations

Topic General Neurology

Presentation(s) P1 - Poster Session 1 (5:30 PM-6:30 PM)

Poster/Presentation
Number 4-026

Objective The National Institute of Neurological Disorders and Stroke (NINDS) initiated the Common Data Element (CDE) project to develop data standards for clinical research in neuroscience. This CDE initiative strives to promote data collection in a consistent format, improve data quality, reduce study start-up time, facilitate data sharing/meta-analyses, and educate new clinical investigators. Imperative to the success of the project is encouraging widespread use of the CDEs and obtaining user feedback to continually improve CDE resources.

Background The CDE project was initiated in 2006 to assist investigators conducting neurological research so they could easily collect data in a standard format and assess common outcomes and endpoints. To remain current as research advances, the CDEs are regularly reviewed and updated.

Design/Methods Disease-specific Oversight Committees are tasked with periodically reviewing and updating the recommendations. NINDS also collaborates with governmental agencies (e.g., National Library of Medicine) and associations (e.g., Chiari & Syringomyelia Foundation) to jointly develop disease recommendations. CDE use is promoted in peer-reviewed publications and at national conferences where participants learn the importance of the CDEs and how to navigate the NINDS CDE website.

Results To date, over 18,000 CDEs and 1,400 case-report forms (CRFs) and instrument recommendations have been developed for 24 diseases. Recent updates include revised Epilepsy and Cerebral Palsy CDEs and CRFs, and a comprehensive update to the Headache CDEs, resulting in version 2.0. The NINDS CDEs or the NINDS CDE website have been mentioned and/or cited in over 187 publications since 2011.

Conclusions The NINDS CDEs are an evolving resource that is updated as research progresses. These CDE updates are important as they help maintain their usability in clinical research, which, in turn, simplifies data sharing and harmonization, data mining, and data warehousing.

Authors/Disclosures
Muniza Sheikh (The Emmes Company, LLC) PRESENTER	Ms. Sheikh has received personal compensation for serving as an employee of The Emmes Company.
	No disclosure on file
Robin S. Feldman (Emmes Company, LLC)	No disclosure on file
Katelyn E. Gay (The Emmes Company, LLC)	Ms. Gay has received personal compensation for serving as an employee of The Emmes Company, LLC.
	No disclosure on file
Kristen R. Joseph, MA (Emmes Corporation)	No disclosure on file
Joy R. Esterlitz (The Emmes Corp)	No disclosure on file
	No disclosure on file

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