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.
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 sub-domains, often used in clinical studies, data standards include:
There are file links for the CRF module or Notice of Copyright that will direct you to where to find the form. The CDE Details
link will take you to a page to download the specific CDEs related to the CRF module or instrument. Due to copyright restrictions
not all instruments have CDEs made for them on our website.
For your reference, a zip file containing all the current General CDE template CRF modules can be downloaded below.
Download General CDE Recommendations
The outline that follows includes all the CDEs associated with the CRF modules,
organized by domain and sub-domain.
NIH Resources
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Participant History and Family History
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Participant Characteristics
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Disease/Injury Related Events
Use the "CRF Search" tool (link at top of page) to choose Domain of "Disease/Injury Related Events", along with a Sub-Domain (e.g., Classification) to locate disease specific CRFs and their associated CDEs. This tool provides you the opportunity to search by Disease, Domain and Sub-Domain.
Disease/Injury Related Events
| CRF Module/Guideline by Sub-Domain | CDEs |
| History of Disease/Injury Event See "CRF Search" to find all History of Disease/Injury Event forms under Subdomain option. |
| Classification See "CRF Search" to find all Classification forms under Subdomain option. |
| Second Insults See "CRF Search" to find all Second Insults forms under Subdomain option. |
| Discharge Information See "CRF Search" to find all Discharge forms under Subdomain option. |
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Assessments and Examinations
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Treatment/Intervention Data
Use the "CRF Search" tool (link at top of page) to choose Domain of "Treatment/Intervention Data", along with a Sub-Domain (e.g., Surgeries and Other Procedures) to locate disease specific CRFs and their associated CDEs. This tool provides you the opportunity to search by Disease, Domain and Sub-Domain.
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Protocol Experience
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Safety Data
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Outcomes and End Points
In this Outcomes and End Points sub-domain, there are numerous measures or instruments that have been recommended and can be found at the "CRF Search" tool (link at top of page) by choosing Domain of " Outcomes and End Points”, along with a Sub-Domain (e.g., Activities of Daily Living/Performance, Assessing Comorbidities, Behavior/Psychiatry, Emotional and Cognitive Status, Functional Status, Neuropsychological Testing, Other Non-Motor, Pediatric and Quality of Life) to locate disease specific CRFs and their associated CDEs. The CRF Search tool provides you the opportunity to search by Disease, Domain and Sub-Domain.
Outcomes and End Points
| CRF Module/Guideline by Sub-Domain | CDEs |
| Activities of Daily Living/Performance See "CRF Search" to find all Activities of Daily Living/Performance forms under Subdomain option. |
| Behavior/Psychiatry See "CRF Search" to find all Behavior/Psychiatry forms under Subdomain option. |
| Assessing Comorbidities See "CRF Search" to find all Assessing Comorbidities forms under Subdomain option. |
| Emotional and Cognitive Status See "CRF Search" to find all Emotional and Cognitive forms under Subdomain option. |
| Neuropsychological Testing See "CRF Search" to find all Neuropsychological Testing forms under Subdomain option. |
| Pediatric See "CRF Search" to find all Pediatric forms under Subdomain option. |
| Performance Measures See "CRF Search" to find all Performance Measures under Subdomain option. |
| Quality of Life See "CRF Search" to find all Quality of Life forms under Subdomain option. |
| Functional Status See "CRF Search" to find all Functional Status forms under Subdomain option. |
| Clinical Event End Points |
Death Report  | CDE Details |
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Prospective Assessments for Suicidal Ideation and Behavior
Investigators should review the FDA’s "Guidance for Industry: Suicidal Ideation and Behavior: Prospective Assessment of Occurrence in Clinical Trials” for the most up-to-date information about suicidal ideation and behavior.
One scale that FDA suggests is the Columbia Suicide Severity Rating Scale (C-SSRS) (available
at
http://www.cssrs.columbia.edu).
Accessibility Statement
The NINDS CDE Team has requested, and in many cases received, permission to post
proprietary instruments/scales recommended by the CDE Working Groups to this site.
When permission is granted, the documents are posted in the exact format they were
received in order to maintain the validity of the instrument. If approval is not
granted for the instrument to be reproduced on this site, with the author/copyright
holder’s permission, a link is posted to an external Web site where users can get
more information about the instrument. If you have difficulty accessing either the
proprietary instruments/scales or the external links, please contact the NINDS Office of Clinical Research at
CRLiaison@ninds.nih.gov.
Download readers:
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.
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.
Complete General CDE Working Group Roster
CDE Steering Committee Members 2011-Present
Voting Members:
- Lucie Bruijn, PhD - ALS Association, Washington, District of Colombia, Chair
- Nicholas Barbaro, MD - University of California, San Francisco, San Francisco, California
- Mitchell Brin, MD - Indiana University Health Neuroscience Center, Indianapolis, Indiana
- Andrew Charles, MD - UCLA School of Medicine, Los Angeles, California
- Gary Cutter, PhD - University of Alabama, Birmingham, Birmingham, Alabama
- Thomas DeGraba, MD - The National Intrepid Center of Excellence, Bethesda, Maryland
- Jordan Elm, PhD - Medical University of South Carolina, Charleston, South Carolina
- Jacqueline French, MD - New York University, Comprehensive Epilepsy Center, New York, New York
- Laurie Gutmann, MD - University of Iowa Carver College of Medicine, Iowa City, Iowa
- Virginia Howard, PhD - University of Alabama, Birmingham, Birmingham, Alabama
- Karl Kieburtz, MD, MPH - University of Rochester Medical Center, Rochester, New York
- Walter Kukull, PhD - University of Washington, School of Public Health, Seattle, Washington
- David Loring, PhD - Emory University, Atlanta, Georgia
- Fred Lublin, MD - Mount Sinai Medical Center, New York, New York
- David Lynch, MD, PhD - University of Pennsylvania, Philadelphia, Pennsylvania
- Richard Moxley, MD - University of Rochester, School of Medicine and Dentistry, Rochester, New York
- Yuko Palesch, PhD - Medical University of South Carolina, Charleston, South Carolina
- Ralph Sacco, MD - University of Miami, Miller School of Medicine, Miami, Florida
- Jeffrey Saver, MD, FAHA, FAAN - University of California, Los Angeles, Geffen School of Medicine, Los Angeles, California
- Ira Shoulson, MD - Georgetown University, Washington, District of Colombia
- Zachary Simmons, MD - Georgetown University, Washington, District of Colombia
- Julie Stout, PhD - Penn State, Hershey Medical Center, Hershey, Pennsylvania
- Caroline Tanner, MD, PhD - The Parkinson's Institute, Sunnyvale, California
Non-Voting Members:
- Chuck Cooper, MD - Office of Translational Sciences, Center for Drug Evaluation and Research (CDER), Food and Drug Administration (FDA) (2011-2013), Washington, District of Columbia
- Michael D'Andrea, PhD - Coriell Institute, Camden, New Jersey
- Michael Feolo, MS - National Center for Biotechnology Information, Bethesda, Maryland
- Bron Kisler - Clinical Data Interchange Standards Consortium (CDISC), Austin, Texas
- Naomi Kleitman, PhD - Craig H. Neilsen Foundation, Encino, California
- Matthew McAuliffe, PhD - Federal Interagency Traumatic Brain Injury Research Project, Bethesda, Maryland
- Erin Ramos, PhD, MPH - National Human Genome Research Institute (NHGRI), National Institutes of Health (NIH), Bethesda, Maryland
- Dianne Reeves, RN, MSN - National Cancer Institute (NCI), National Institutes of Health (NIH), Bethesda, Maryland
- Yaffa Rubinstein, PhD - National Center for Advancing Translational Sciences (NCATS), National Institutes of Health (NIH), Bethesda, Maryland
- Chi Tarn, PhD - Coriell Institute for Medical Research, Camden, New Jersey
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CDE Steering Committee Members 2006-2010
The NINDS CDE Project Team began developing the General CDEs in early 2006. As the
Project Overview explains, the Team identified the
initial draft set of General CDEs by reviewing the literature, case report forms
(CRFs) from large NINDS-funded studies, other clinical data standards, and regulatory
requirements. They convened a meeting on April 26, 2006 to present the draft set
of General CDE materials to a small group of experienced clinical research investigators
in neurology:
- Roderick Corriveau, PhD - Coriell Institute for Medical Research, Camden, New Jersey
- Gary Cutter, PhD - University of Alabama School of Public Health, Birmingham, Alabama
- Laurie Gutmann, MD - National Institute of Neurological Disorders and Stroke (NINDS), National Institutes of Health (NIH), Bethesda, Maryland
- Chelsea Kidwell, MD - Georgetown University, Washington, District of Colombia
- Karl Kieburtz, MD, MPH - University of Rochester, Rochester, New York
- Roger Kurlan, MD - University of Rochester, Rochester, New York
- Andrew Maas, MD, PhD - University Hospital Antwerp, Edegem, Belgium
- Yuko Palesch, PhD - Medical University of South Carolina, Charleston, South Carolina
- Ralph Sacco, MD, MS - University of Miami, Miller School of Medicine, Miami, Florida
- Barbara Tilley, PhD - University of Texas School of Public Health, Austin, Texas
At the meeting and for sometime afterwards, the researchers listed above offered
direction and guidance to the overall NINDS CDE Project and also provided more specific
feedback about the General CDEs.
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NINDS CDE Team
The following NINDS CDE Team members also helped develop the General CDEs:
- Joanne Odenkirchen, MPH - NINDS CDE Project Officer, National Institute of Neurological Disorders and Stroke (NINDS), National Institutes of Health (NIH), Bethesda, Maryland
- Sherita Ala'i Hansen, MS - The EMMES Corporation, Rockville, Maryland
- Matthew Beyers, M.Sc. - The EMMES Corporation, Rockville, Maryland
- Joy Esterlitz, MS - The EMMES Corporation, Rockville, Maryland
- Pamela West - The EMMES Corporation, Rockville, Maryland
- Test T. Testerson, ThD - Institute of Testing, Testerton, West Test
- John Marler, MD - National Institute of Neurological Disorders and Stroke (NINDS), National Institutes of Health (NIH), Bethesda, Maryland
- Stacie Grinnon, MS - KAI Research, Inc. (An Altarum Company), Rockville, Maryland
- Selma Kunitz, PhD - KAI Research, Inc. (An Altarum Company), Rockville, Maryland
- Yun Lu, PhD - KAI Research, Inc. (An Altarum Company), Rockville, Maryland
- Kristy Miller, MPH - KAI Research, Inc. (An Altarum Company), Rockville, Maryland
- Christina You, MSPH - KAI Research, Inc. (An Altarum Company), Rockville, Maryland
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