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)
Mitochondrial Disease Start-up Resource Listing: All Core and Supplemental–Highly Recommended CDEs recommended for Mitochondrial Disease study start-up
Mitochondrial Disease Highlight Summary: Overview of all Mitochondrial 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 National Institute of Neurological Disorders and Stroke (NINDS) convened the Mitochondrial Disease v1.0 Common Data Elements (CDE) Working Group (WG) in 2014. The Mitochondrial Disease v1.0 CDE WG was divided into 9 domain-specific subgroups. The first set of CDEs for Mitochondrial Disease was completed in 2015.
The Mitochondrial Disease CDE Oversight Committee (OC) was created in 2018 to periodically review, direct the updating, and advance the development of Mitochondrial Disease CDEs.
In 2022, the Mitochondrial Diseases v2.0 CDE WG was convened to perform a comprehensive review and update of the Mitochondrial Disease v1.0 CDEs.
The WG used a common definition of primary mitochondrial diseases to help focus this review and standardize the recommendations: Mitochondrial Disease Definition.
The WG was divided into 11 domain-specific subgroups: Audiology Outcomes, Biomarkers, Cognitive/Psychological Outcomes, Endocrinology, Exercise Physiology, GI/Hepatology and Nutrition, General Medical/Neurological Assessments, Genetics, Imaging, Ophthalmology Outcomes, and Patient Reported Outcomes (PRO)/Quality of Life (QoL)/Fatigue.
The Internal Review and Public Review period for the draft Mitochondrial Disease v2.0 CDEs was October 18, 2023 – November 15, 2023. The final Mitochondrial Disease v2.0 CDE recommendations were posted in March 2024.
Roster
Members of the Mitochondrial Disease v2.0 CDE Working Group by subgroup, current members of the Oversight Committee, the NIH Coordinating Team and the NINDS CDE Team are listed below. A roster spreadsheet can be downloaded from this link below.
Lists members of the Mitochondrial Disease v1.0 CDE Working Group by subgroup, previous members of the NIH Coordinating Team and the NINDS CDE Team.
Please see the Overview tab for additional project background and timeline information.
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.