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)
Huntington's Disease Start-up Resource Listing: All Core and Supplemental–Highly Recommended CDEs recommended for Huntington's Disease study start-up
Huntington's Disease Highlight Summary: Overview of all Huntington's Disease-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 Huntington’s Disease was developed in 2011.
To develop the Huntington’s disease (HD) CDEs, the Huntington’s disease CDE Working Group divided into subgroups to focus on identifying and defining data elements in the domains of:
- Motor
- Imaging Biomarkers
- Biochemical Markers
- Genetics
- Epidemiology/Environment
- Functional Outcomes/Patient Reported Outcomes
- Behavior/ Psychiatry
- Pathology
- Operations
- Cognitive
- Scale Metrics and Statistics
Roster
The Huntington’s Disease CDE Working Group was comprised of eleven 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 HD CDE Working Group was supported by the NINDS CDE Team. The complete HD CDE Working Group roster and the rosters by Subgroup are shown below.
The Working Group members served on one subgroup. The subgroups began meeting by teleconference in March 2011 and continued to hold calls every four to six weeks through fall 2011 to define the CDEs for their domains and to recommend standardized, validated instruments for HD research. The Huntington Disease CDE Oversight Committee was created in 2016.
Publications
A publication related to the Huntington's Disease 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.