Data Standards
The National Institute of Neurological Disorders and Stroke (NINDS) and other Federal agencies and international organizations have the common mission of developing data standards for clinical research. The development of the first set of General Common Data Elements (CDEs) began in 2006. The General CDEs were not developed by a Working Group like the disease specific CDEs. Rather the NINDS CDE Team developed the General CDEs by first identifying those data elements that were common across neurological diseases and then harmonizing these common data elements with other relevant clinical data standards (refer to the Project Overview for more information). The NINDS CDE Steering Committee initially reviewed and continues to oversee all revisions and additions to the General CDEs.
The Core data elements to be used by an investigator when beginning a research study in all NINDS related studies are listed in the Start-up Resource Listing.
Digital technology is an important emerging area in clinical research. In 2022, the NINDS Parkinson’s Disease v2.0 CDE Digital Technology Subgroup developed two guidance documents for this subdomain which may also have utility across disorder areas. Please refer to Best Practices for Digital Health Outcomes and Guidance for Digital Data Sharing for more information.
Many of the CDEs will overlap across study types, which allows for comparisons and meta-analysis across studies. Consistency of the data elements and the CDE formats is kept in order to ensure the ability to transfer critical medical information electronically from one center to another. This consistency also allows for continuity across different disease areas. The goals of the NINDS CDE initiative are to increase the efficiency and effectiveness of clinical research studies and clinical treatment, increase data quality, facilitate data sharing, and help educate new clinical investigators.
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 — logically organize CDEs for data collection
- Guidance Documents — to provide further information about the CDEs.
- Instrument Notice of Copyright (NOC) Documents — Include pertinent information on recommended instruments (Instrument Notice of Copyright Information)
There are file links for the CRF module or Notice of Copyright that will allow you to view and/or download the form. The corresponding CDE Details link will direct you to a separate page to download the specific CDEs related to that CRF module or instrument. Please note that not all instruments have CDE details available, due to copyright restrictions.
The outline that follows includes all the CDEs associated with the CRF modules, organized by domain and subdomain.
Click Expand All to view the CDEs associated with the CRF modules, organized by domain and subdomain.
Overview
The development of General Common Data Elements were the initial focus of the Common Data Element (CDE) Project and were first published (Version 1.0) on this Web site in 2007. The General CDE Standards are designed to be applicable to studies involving a wide range of neurological disease and conditions. Examples of elements included in the General CDEs are: demographic data, medical history data, treatment and intervention data, and safety data. Investigators are encouraged to collect these data elements, if appropriate, in their clinical research studies.
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 available below are organized into domains which are intuitive and common to most clinical research studies. Select a domain of interest below to find the related data standards.
Roster
The General CDEs were not developed by a Working Group like the disease-specific CDEs. Rather the NINDS CDE Team developed the General CDEs by identifying those data elements that were common across neurological diseases and attempting to harmonize with other relevant clinical data standards (refer to the Project Overview for more information). The General CDEs were initially reviewed by the NINDS CDE Steering Committee and that committee continues to oversee all revisions and additions to the General CDEs. The rosters for the CDE Steering Committee and the NINDS CDE Team, including downloadable versions, are shown below.
Publications
- Sheehan J, Hirschfeld S, Foster E, Ghitza U, Goetz K, Karpinski J, Lang L, Moser RP, Odenkirchen J, Reeves D, Rubinstein Y, Werner E, Huerta M. Improving the value of clinical research through the use of Common Data Elements. Clin Trials. 2016 Dec;13(6):671-676. Epub 2016 Jun 15. PubMed PMID: 27311638.
- Shapiro E, Bernstein J, Adams HR, Barbier AJ, Buracchio T, Como P, Delaney KA, Eichler F, Goldsmith JC, Hogan M, Kovacs S, Mink JW, Odenkirchen J, Parisi MA, Skrinar A, Waisbren SE, Mulberg AE. Neurocognitive clinical outcome assessments for inborn errors of metabolism and other rare conditions. Mol Genet Metab. 2016 Jun;118(2):65-9. PubMed PMID: 27132782.
- Grinnon ST, Miller K, Marler JR, Lu Y, Stout A, Odenkirchen J, Kunitz S. National Institute of Neurological Disorders and Stroke Common Data Element Project - approach and methods. Clin Trials. 2012 Jun;9(3):322–329. PubMed PMID: 22371630.
- Stone K. NINDS common data element project: A long-awaited breakthrough in streamlining trials. Ann Neurol., 2010 Jul; 68(1): A11–A13. PubMed PMID: 20583225.
Publications
- Sheehan J, Hirschfeld S, Foster E, Ghitza U, Goetz K, Karpinski J, Lang L, Moser RP, Odenkirchen J, Reeves D, Rubinstein Y, Werner E, Huerta M. Improving the value of clinical research through the use of Common Data Elements. Clin Trials. 2016 Dec;13(6):671-676. Epub 2016 Jun 15. PubMed PMID: 27311638.
- Shapiro E, Bernstein J, Adams HR, Barbier AJ, Buracchio T, Como P, Delaney KA, Eichler F, Goldsmith JC, Hogan M, Kovacs S, Mink JW, Odenkirchen J, Parisi MA, Skrinar A, Waisbren SE, Mulberg AE. Neurocognitive clinical outcome assessments for inborn errors of metabolism and other rare conditions. Mol Genet Metab. 2016 Jun;118(2):65-9. PubMed PMID: 27132782.
- Grinnon ST, Miller K, Marler JR, Lu Y, Stout A, Odenkirchen J, Kunitz S. National Institute of Neurological Disorders and Stroke Common Data Element Project - approach and methods. Clin Trials. 2012 Jun;9(3):322–329. PubMed PMID: 22371630.
- Stone K. NINDS common data element project: A long-awaited breakthrough in streamlining trials. Ann Neurol., 2010 Jul; 68(1): A11–A13. PubMed PMID: 20583225.
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.