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)
Parkinson's Disease Start-up Resource Listing: All Core and Supplemental–Highly Recommended CDEs recommended for Parkinson's Disease study start-up
Parkinson's Disease Highlight Summary: Overview of all Parkinson'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 National Institute of Neurological Disorders and Stroke (NINDS) convened the Parkinson's Disease (PD) v1.0 Common Data Elements (CDE) Working Group (WG) in 2009. The PD v1.0 CDE WG brought together over 50 experts from nine countries divided into 12 subgroups/specialty areas. The subgroups defined the CDEs for their domains and recommended standardized, validated instruments for PD research. The first set of CDEs for PD was completed in 2010.
The PD CDE Oversight Committee (OC) was created in 2016 to periodically review, direct the updating, and advance the development of PD CDEs.
In 2021, the PD v2.0 CDE WG was convened to perform a comprehensive review and update of the PD CDEs. The WG was divided into 11 domain-specific subgroups and a biostatistician served as a consultant on scale metrics and statistics. The PD v2.0 CDE recommendations were posted in August 2022.
PD v2.0 CDE Subgroups:
- Cognitive
- Digital Technology
- Epidemiology and Environment
- Functional Neurosurgery
- General and Motor
- Genetics
- Imaging
- Neuropathology
- Other Non-Motor
- Psychiatry
- Quality of Life
Roster
Members of the Parkinson’s Disease v2.0 CDE Working Group by subgroup, current members of the Oversight Committee, and the NINDS CDE Team are listed below. A roster spreadsheet can be downloaded from this link below.
Complete Version 1.0 Parkinson’s Disease CDE Working Group Roster – Lists members of the Parkinson’s Disease v1.0 CDE Working Group by subgroup, previous members of the Oversight Committee, and the NINDS CDE Team.
Please see the Overview tab for additional project background and timeline information.
Publications
A publication related to the Parkinson’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.