Friedreich's Ataxia

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)

Friedreich's ataxia Start-up Resource Listing: All Core and Supplemental–Highly Recommended CDEs recommended for Friedreich's ataxia study start-up

Friedreich's ataxia Highlight Summary: Overview of all Friedreich's ataxia-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 Friedreich’s ataxia (FA) was developed in 2011. 

To develop the Friedreich’s ataxia (FA) CDEs, the FA CDE Working Group divided into subgroups to focus on identifying and defining data elements in the domains of:

  • Ataxia and Performance Measures
  • Biomarkers
  • Cardiac and Clinical Outcomes
  • Demographics, Medical History/ Prior Health Status, Laboratory Tests/ Vital Signs

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.

Roster

The National Institute of Neurological Disorders and Stroke (NINDS) has formed an Oversight Committee to direct the updating and further development of Friedreich’s ataxia CDEs. The Friedreich’s ataxia CDE Committee is supported by the NINDS CDE Team.

Previously, the Friedreich’s ataxia CDE Committee was comprised of four 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 Working Group members served on either one or two subgroups. The subgroups began meeting by teleconference in August 2010 and continued to hold calls every four to six weeks through early 2011 to define the CDEs for their domains and to recommend standardized, validated instruments for Friedreich’s ataxia research. The Friedreich’s ataxia CDE Oversight Committee was created in 2013.

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.

Friedreich's ataxia CDE Revision History