Data Standards
Organized by domains and subdomains often used in clinical studies, data standards include:
- CDEs — Classified as Core, Supplemental–Highly Recommended, Supplemental, or Exploratory
- CRF Modules — Template forms that logically organize CDEs for data collection
- Guidance Documents — Provide further information about the CDEs
- Instrument Notice of Copyright (NOC) Documents — Include pertinent information on recommended instruments (Instrument Notice of Copyright Information)
Epilepsy Start-up Resource Listing: All Core and Supplemental–Highly Recommended CDEs recommended for Epilepsy study start-up
Epilepsy Highlight Summary: Overview of all Epilepsy-specific CDE recommendations as they appear on the website
Click Expand All to view the CDEs associated with the CRF modules, organized by domain and subdomain.
Overview
The first set of Common Data Elements (CDEs) for Epilepsy was developed in 2010. The Epilepsy Common Data Elements (CDEs) follow the recommendations of the Epilepsy CDE Working Group (WG), a committee of experts in the field (see Roster).
The NINDS recognizes that the Epilepsy CDEs are dynamic tools that will continue to evolve over time. Consequently, the Epilepsy CDEs will be periodically reviewed and updated based on feedback from the epilepsy community and changes in the clinical research landscape.
Data standards include CDEs as well as case report form (CRF) Modules and Guidelines. The CRF Modules logically organize the CDEs for data collection, while the Guidelines provide further information about the CDEs. The CDEs, CRF Modules, and Guidelines presented are organized into domains which are intuitive and common in clinical research studies.
Download a “checklist” – Checklist for Epilepsy Clinical Trials OR Checklist for Other Epilepsy Clinical Studies – to help locate the CRF Modules in the Data Standards. Each checklist provides an outline of the CRF Modules that may be needed for an Epilepsy clinical trial/ other type of clinical study.
Roster
The National Institute of Neurological Disorders and Stroke (NINDS) has currently formed an Oversight Committee to direct the updating and further development of Epilepsy CDEs. The Epilepsy CDE Committee is supported by the NINDS CDE Team.
Previously, the Epilepsy CDE Committee was comprised of nine different subgroups. Chairs were appointed to lead the overall Working Group and the individual subgroups. The Working Group members actively develop the CDEs for their specific subgroups and also have an opportunity to review and comment on the recommendations of the other subgroups.
The Epilepsy CDE Committee first convened in December 2009 and divided into subgroups to focus on identifying and defining data elements across epilepsy domains. Members served on either one or two subgroups. Subgroup conference calls began in April 2009 and continued every four to six weeks through the spring of 2010. The subgroups of the Epilepsy CDE WG took a couple different approaches. Some groups opted to define the CDEs by creating template data collection form(s) and others decided it was more appropriate to recommend standardized, validated instruments for specific domains of epilepsy research. The Epilepsy CDE Oversight Committee was created in 2011.
Publications
Publications
- Grinnon ST, Miller K, Marler JR, Lu Y, Stout A, Odenkirchen J, Kunitz S. National Institute of Neurological Disorders and Stroke Common Data Element Project - approach and methods. Clin Trials. 2012 Jun; 9(3):322–329. PubMed PMID: 22371630.
- Loring DW, Lowenstein DH, Barbaro NM, Fureman BE, Odenkirchen J, Jacobs MP, Austin JK, Dlugos DJ, French JA, Gaillard WD, Hermann BP, Hesdorffer DC, Roper SN, Van Cott AC, Grinnon S, Stout A. Common data elements in epilepsy research: Development and implementation of the NINDS epilepsy CDE project. Epilepsia. 2011 Jun; 52(6):1186–1191. PubMed PMID: 21426327.
- Loring, DW & Hermann, BP. Neuropsychology and the epilepsy common data element project. In: Helmstaedter, C, Lassonde, M, Hermann, B, Kahane, P, and Arzimanoglou, A. Neuropsychology in the Care of People with Epilepsy. Paris: John Libbey Eurotext; 2011:59–68.
Updates
Please see attached revision history document. Please contact NINDSCDE@emmes.com if you require further information or have any questions about the revision history.