Amyotrophic Lateral Sclerosis

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)

Amyotrophic Lateral Sclerosis Start-up Resource Listing: All Core and Supplemental–Highly Recommended CDEs recommended for Amyotrophic Lateral Sclerosis study start-up

Amyotrophic Lateral Sclerosis Highlight Summary: Overview of all Amyotrophic Lateral 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 Amyotrophic Lateral Sclerosis was developed in 2011.

To develop the Amyotrophic Lateral Sclerosis (ALS) CDEs, the ALS CDE Working Group divided into subgroups to focus on identifying and defining data elements in the domains of:

  • Biomarkers and Imaging
  • Clinical Research/ Quality of Life
  • Cognitive/ Frontotemporal Dementia
  • Genetics

Roster

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

Previously, the Amyotrophic Lateral Sclerosis CDE Committee was currently 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 November 2010 and continued to hold calls every four to six weeks through spring 2011 to define the CDEs for their domains and to recommend standardized, validated instruments for ALS research. The Amyotrophic Lateral Sclerosis 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.

Amyotrophic Lateral Sclerosis CDE Revision History