Organized into domains often used in clinical studies, data standards
include:
- CDEs
- CRF Modules logically organize CDEs for data collection
- Guidelines to provide further information about the CDEs.
For your reference, a zip file containing all of the General CDE 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.
Participant/Subject Characteristics
Participant/Subject Characteristics
CRF Module/Guideline by Sub-Domain |
Download |
CDEs |
© or TM |
Demographics |
Demographics
|
67KB DOC |
HTML |
|
Supplemental Demographics Data Elements This form only contains supplemental CDEs which may be used on a form for any neurological disorder, but only need to be applied where they are relevant to collection of data for a protocol.
|
N/A |
HTML |
|
Social Status |
Social Status
|
54KB DOC |
HTML |
|
Supplemental Social Status Data Elements This form only contains supplemental CDEs which may be used on a form for any neurological disorder, but only need to be applied where they are relevant to collection of data for a protocol.
|
N/A |
HTML |
|
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Participant/Subject History and Family History
Participant/Subject History and Family History
CRF Module/Guideline by Sub-Domain |
Download |
CDEs |
© or TM |
General Health History |
Medical History
|
73KB DOC |
HTML |
|
Family History
|
84KB DOC |
HTML |
|
Behavioral History
|
125KB DOC |
HTML |
|
Supplemental Health History This form only contains supplemental CDEs which may be used on a form for any neurological disorder, but only need to be applied where they are relevant to collection of data for a protocol.
|
N/A |
HTML |
|
Epidemiology/Environmental History |
Supplemental Epidemiology or Environmental History Data Elements This form only contains supplemental CDEs which may be used on a form for any neurological disorder, but only need to be applied where they are relevant to collection of data for a protocol.
|
N/A |
HTML |
|
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Disease/Injury Related Events
Disease/Injury Related Events
CRF Module/Guideline by Sub-Domain |
Download |
CDEs |
© or TM |
History of Disease/Injury Event |
Supplemental History of Disease or Injury Event Data Elements This form only contains supplemental CDEs which may be used on a form for any neurological disorder, but only need to be applied where they are relevant to collection of data for a protocol.
|
N/A |
HTML |
|
Classification |
Supplemental Classification Data Elements This form only contains supplemental CDEs which may be used on a form for any neurological disorder, but only need to be applied where they are relevant to collection of data for a protocol.
|
N/A |
HTML |
|
Second Insults |
Supplemental Second Insults Data Elements This form only contains supplemental CDEs which may be used on a form for any neurological disorder, but only need to be applied where they are relevant to collection of data for a protocol.
|
N/A |
HTML |
|
Discharge Information |
Supplemental Discharge Data Elements This form only contains supplemental CDEs which may be used on a form for any neurological disorder, but only need to be applied where they are relevant to collection of data for a protocol.
|
N/A |
HTML |
|
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Assessments and Examinations
Assessments and Examinations
CRF Module/Guideline by Sub-Domain |
Download |
CDEs |
© or TM |
Physical/Neurological Examination |
Physical Exam
|
78KB DOC |
HTML |
|
Supplemental Physical/Neurological Examination Data Elements This form only contains supplemental CDEs which may be used on a form for any neurological disorder, but only need to be applied where they are relevant to collection of data for a protocol.
|
N/A |
HTML |
|
Vital Signs and Other Body Measures |
Vital Signs
|
66KB DOC |
HTML |
|
Supplemental Vital Signs and Other Body Measures Data Elements This form only contains supplemental CDEs which may be used on a form for any neurological disorder, but only need to be applied where they are relevant to collection of data for a protocol.
|
N/A |
HTML |
|
Laboratory Tests and Biospecimens/Biomarkers |
Laboratory Tests and Tracking
|
101KB DOC |
HTML |
|
Coriell's Control Data Elements
|
Coriell  |
N/A |
|
Supplemental Laboratory Tests and Biospecimens/Biomarkers Data Elements This form only contains supplemental CDEs which may be used on a form for any neurological disorder, but only need to be applied where they are relevant to collection of data for a protocol.
|
N/A |
HTML |
|
Imaging Diagnostics |
General Imaging Diagnostics This form only contains supplemental CDEs which may be used on a form for any neurological disorder, but only need to be applied where they are relevant to collection of data for a protocol.
|
N/A |
HTML |
|
Non-Imaging Diagnostics |
Electrocardiogram (ECG)
|
75KB DOC |
HTML |
|
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Treatment/Intervention Data
Treatment/Intervention Data
CRF Module/Guideline by Sub-Domain |
Download |
CDEs |
© or TM |
Drugs |
Prior and Concomitant Medications
|
53KB DOC |
HTML |
|
Study Drug Dosing
|
61KB DOC |
HTML |
|
Study Drug Compliance
|
51KB DOC |
HTML |
|
Supplemental Drugs Data Elements This form only contains supplemental CDEs which may be used on a form for any neurological disorder, but only need to be applied where they are relevant to collection of data for a protocol.
|
N/A |
HTML |
|
Surgeries and Other Procedures |
Supplemental Surgeries and Other Procedures Data Elements This form only contains supplemental CDEs which may be used on a form for any neurological disorder, but only need to be applied where they are relevant to collection of data for a protocol.
|
N/A |
HTML |
|
Therapies |
Study Therapies Compliance
|
47KB DOC |
HTML |
|
Supplemental Therapies Data Elements This form only contains supplemental CDEs which may be used on a form for any neurological disorder, but only need to be applied where they are relevant to collection of data for a protocol.
|
N/A |
HTML |
|
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Protocol Experience
Protocol Experience
CRF Module/Guideline by Sub-Domain |
Download |
CDEs |
© or TM |
Participant/Subject Identification, Eligibility, and Enrollment |
Screening Log
|
68KB DOC |
N/A |
|
Inclusion and Exclusion Criteria
|
52KB DOC |
HTML |
|
Informed Consent and Enrollment
|
63KB DOC |
HTML |
|
Supplemental Enrollment Data Elements This form only contains supplemental CDEs which may be used on a form for any neurological disorder, but only need to be applied where they are relevant to collection of data for a protocol.
|
N/A |
HTML |
|
Protocol Deviations |
Protocol Deviations
|
51KB DOC |
HTML |
|
Off Treatment/Off Study |
Study Discontinuation/Completion
|
63KB DOC |
HTML |
|
Study Management |
Participant/Subject Contact Information
|
44KB DOC |
N/A |
|
Visit Checklist
|
52KB DOC |
N/A |
|
Visit Schedule
|
66KB DOC |
N/A |
|
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Safety Data
Safety Data
CRF Module/Guideline by Sub-Domain |
Download |
CDEs |
© or TM |
Adverse Events |
Adverse Events
|
80KB DOC |
HTML |
|
Serious Adverse Events
|
71KB DOC |
N/A |
|
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Outcomes and End Points
The CDEs from copyright-protected measures are intentionally excluded from this site unless permission was received from the copyright holder. If the measure is not included, please contact the publisher or person who holds the copyright to obtain a copy of the measure.
Outcomes and End Points
CRF Module/Guideline by Sub-Domain |
Download |
CDEs |
© or TM |
Clinical Event End Points |
Death Report
|
51KB DOC |
HTML |
|
Other Clinical Data |
Supplemental Other Clinical Data Data Elements This form only contains supplemental CDEs which may be used on a form for any neurological disorder, but only need to be applied where they are relevant to collection of data for a protocol.
|
N/A |
HTML |
|
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Prospective Assessments for Suicidality
Investigators should use the Columbia Suicide Severity Rating Scale (C-SSRS) (available
at
http://www.cssrs.columbia.edu, see additional C-SSRS information for
background materials provided to the NINDS CDE project by Dr. Posner) or another
instrument that maps to the Columbia Classification Algorithm for Suicide Assessment
(C-CASA) (Posner et al. 2007).
Posner, K, MA Oquendo, M Gould, B Stanley, and M Davies, 2007, Columbia Classification
Algorithm of Suicide Assessment
(C-CASA): Classification of Suicidal Events in the FDA’s Pediatric Suicidal Risk
Analysis of Antidepressants, Am J Psychiatry, 164:1035-1043.
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 CDE Project Officer, Joanne Odenkirchen.
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 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
- Gary Cutter, PhD - University of Alabama School of Public Health
- Yang Faan, PhD - National Institute of Neurological Disorders and Stroke (NINDS), National Institutes of Health (NIH)
- Laurie Gutmann, MD - National Institute of Neurological Disorders and Stroke (NINDS), National Institutes of Health (NIH)
- Chelsea Kidwell, MD - Georgetown University
- Karl Kieburtz, MD, MPH - University of Rochester
- Roger Kurlan, MD - University of Rochester
- Andrew Maas, MD, PhD - University Hospital Antwerp, Belgium
- Yuko Palesch, PhD - Medical University of South Carolina
- Ralph Sacco, MD, MS - University of Miami
- Barbara Tilley, PhD - University of Texas School of Public Health
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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CDE Steering Committee Members 2011-Present
Voting Members:
- Nicholas Barbaro, MD - University of California, San Francisco
- Gary Cutter, PhD - University of Alabama, Birmingham
- Thomas DeGraba, MD - The National Intrepid Center of Excellence
- Jordan Elm, PhD - Medical University of South Carolina
- Jacqueline French, MD - New York University, Comprehensive Epilepsy Center
- Virginia Howard, PhD - University of Alabama, Birmingham
- Karl Kieburtz, MD, MPH - University of Rochester Medical Center
- Walter Kukull, PhD - University of Washington, School of Public Health
- David Loring, PhD - Emory University
- Fred Lublin, MD - Mount Sinai Medical Center
- David, Lynch, MD, PhD - University of Pennsylvania
- Dick Moxley, MD - University of Rochester, School of Medicine and Dentistry
- Yuko Palesch, PhD - Medical University of South Carolina
- Ralph Sacco, MD - University of Miami, Miller School of Medicine
- Jeffrey Saver, MD, FAHA, FAAN - University of California, Los Angeles, Geffen School of Medicine
- Ira Shoulson, MD - Georgetown University
- Zachary Simmons, MD - Penn State, Hershey Medical Center
- Julie Stout, PhD - Monash University
- Caroline Tanner, MD, PhD - The Parkinson's Institute
Non-Voting Members:
- Chuck Cooper, MD - Office of Translational Sciences, Center for Drug Evaluation and Research (CDER), Food and Drug Administration (FDA)
- Michael D'Andrea, PhD - Coriell Institute
- Michael Feolo, MS - National Center for Biotechnology Information
- Bron Kisler - Clinical Data Interchange Standards Consortium (CDISC)
- Erin Ramos, PhD, MPH - National Human Genome Research Institute (NHGRI), National Institutes of Health (NIH)
- Dianne Reeves, RN, MSN - National Cancer Institute, Center for Bioinformatics
- Yaffa Rubinstein, PhD - Office of Rare Diseases Research, National Institutes of Health (NIH)
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NINDS CDE Team
The following NINDS CDE Team members also helped develop the General CDEs:
- Sherita Ala'i, MS - The EMMES Corporation, Rockville, Maryland, USA
- Sarah Duwel, RN, MA - The EMMES Corporation, Rockville, Maryland, USA
- Joshua Hagel - The EMMES Corporation, Rockville, Maryland, USA
- Petra Kaufmann, MD, MSc - National Institute of Neurological Disorders and Stroke (NINDS), National Institutes of Health (NIH)
- John Marler, MD - National Institute of Neurological Disorders and Stroke (NINDS), National Institutes of Health (NIH)
- Joanne Odenkirchen, MPH - National Institute of Neurological Disorders and Stroke (NINDS), National Institutes of Health (NIH)
- Angela Soriano - The EMMES Corporation, Rockville, Maryland, USA
- Pamela West - The EMMES Corporation, Rockville, Maryland, USA
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The General CDEs were updated in January 2013 to increase the application of existing data elements available across
neurological disorders where relevant for data collection. The document below describes all the revisions incorporated
in the January 2013 version compared to the previous versions dated June 2012 and February 2011.
Please contact NINDSCDE@emmes.com if you require further information or have
any questions about the revision history.
General
CDEs Revision History - Jan 2013