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)
Multiple Sclerosis Start-up Resource Listing: All Core and Supplemental–Highly Recommended CDEs recommended for Multiple Sclerosis study start-up
Multiple Sclerosis Highlight Summary: Overview of all Multiple Sclerosis-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 Multiple Sclerosis was developed in 2011.
To develop the Multiple Sclerosis (MS) CDEs, the MS CDE Working Group divided into subgroups to focus on identifying and defining data elements in the domains of:
- Biospecimens
- Demographics and Clinical Assessments
- Imaging
- Neuropsychology/Cognition
- Operations/Special Advisors
Roster
The National Institute of Neurological Disorders and Stroke (NINDS) has formed an Oversight Committee to direct the updating and further development of Multiple Sclerosis CDEs. The Multiple Sclerosis CDE Committee is supported by the NINDS CDE Team.
Previously, the Multiple Sclerosis CDE Committee was currently comprised of five different subgroups. Chairs were appointed to lead the overall Working Group and the individual subgroups. The Working Group members actively developed the CDEs for their specific subgroups and also had an opportunity to review and comment on the recommendations of the other subgroups.
The subgroups began meeting by teleconference in February 2011 and continued to hold calls every four to six weeks through the fall of 2011 to define the CDEs for their domains and to recommend standardized, validated instruments for MS research. The Multiple Sclerosis CDE Oversight Committee was created in 2013.
Publications
A publication related to the MS CDE initiative will be written at a later date. The citation for this publication will be included on this site as soon as it is available.
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.