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.

Publications

Publications related to the ALS CDE Effort

Sherman AV, Gubitz AK, Al-Chalabi A, Bedlack R, Berry J, Conwit R, Harris BT, Horton DK, Kaufmann P, Leitner ML, Miller R, Shefner J, Vonsattel JP, Mitsumoto H.2013. Infrastructure resources for clinical research in amyotrophic lateral sclerosis. Amyotroph Lateral Scler Frontotemporal Degener. 2013 May; 14 Suppl 1:53-61. PubMed PMID: 23678880.

Presentations related to other CDE Effort

February 2010 – Frontotemporal Dementias Common Data Element Workshop, February 2-3, 2010, , Miami, Florida. The National Institute of Neurological Disorders and Stroke (NINDS) Common Data Elements (CDE). Authors: Margaret Sutherland (NINDS)

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

Instrument Notice of Copyright Information

The NINDS CDE Team does not post proprietary instruments/scales recommended by the CDE Working Groups on this website. This includes, but is not limited to, copyrighted or trademarked instruments/scales. Information about recommended instruments can be found in the Notice of Copyright (NOC) documents under ‘CRF Module/Guidance’ on each disorder’s data standards page. For any questions regarding these instruments/scales please contact the corresponding owner/author. The NINDS CDE Team is not responsible for the availability or content of these external sites, nor does the NINDS CDE Team endorse, warrant or guarantee the products, services or information described or offered at these other internet sites.