TBI Version 2.0 CDEs - Call for Public Review
The TBI Version 2.0 CDEs are now open for review from May 7, 2012 through June 15,
2012. Please submit your feedback by June 15, 2012.
The TBI Version 2.0 CDE Working Group and the NINDS CDE Team have released a draft
version of the TBI Version 2.0 CDEs for public review. After the open comment period,
the TBI Version 2.0 CDE Working Group will review comments and make updates in order
to publish Version 2.0 of the TBI CDEs by early July 2012.
For your reference, a zip file containing the DRAFT TBI Version 2.0 CDE review package
can be downloaded below. Please read the overview document first (“1. TBI CDE Public
Review Package Overview.doc”) after unzipping the file.
Download TBI Version 2.0 CDE
review package

The TBI Version 1.0 CDEs are included directly below. Version 2.0 will replace Version
1.0 when it is officially published on this site.
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.
Select a domain of interest below to find the related data standards.
Participant/Subject Characteristics
Note: The data elements included in the modules labeled “Pediatric” were considered to be specific to pediatric TBI. However, the modules labeled “Adult” may also include elements relevant but not specific to pediatric TBI.
Participant/Subject Characteristics
| CRF Module/Guideline by Sub-Domain |
Download |
CDEs |
| Demographics |
| Demographics - Adult |
N/A |
HTML |
| Demographics - Pediatric |
N/A |
HTML |
| Social Status |
| Socioeconomic Status - Adult |
N/A |
HTML |
| Socioeconomic Status - Pediatric |
N/A |
HTML |
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Participant/Subject History and Family History
Note: The data elements included in the modules labeled “Pediatric” were considered to be specific to pediatric TBI. However, the modules labeled “Adult” may also include elements relevant but not specific to pediatric TBI.
Participant/Subject History and Family History
| CRF Module/Guideline by Sub-Domain |
Download |
CDEs |
| General Health History |
| Significant Medical History - Adult |
N/A |
HTML |
| Significant Medical History - Pediatric |
N/A |
HTML |
| Behavioral History |
N/A |
HTML |
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Disease/Injury Related Events
Note: The data elements included in the modules labeled “Pediatric” were considered to be specific to pediatric TBI. However, the modules labeled “Adult” may also include elements relevant but not specific to pediatric TBI.
Disease/Injury Related Events
| CRF Module/Guideline by Sub-Domain |
Download |
CDEs |
| History of Disease/Injury Event |
| Definition of Traumatic Brain Injury |
32KB DOC |
N/A |
| Ohio State University TBI Identification Method Short Form |
N/A |
HTML |
| Screening for TBI in Military Personnel |
N/A |
HTML |
| Injury Presentation - Early/Late - Adult |
N/A |
HTML |
| Injury Presentation - Early/Late - Pediatric |
N/A |
HTML |
| Type, Place, Cause and Mechanism of Injury - Adult |
N/A |
HTML |
| Type, Place, Cause and Mechanism of Injury - Pediatric |
N/A |
HTML |
| Classification |
| Injuries and Injury Severity - Adult |
N/A |
HTML |
| Injuries and Injury Severity - Pediatric |
N/A |
HTML |
| Baseline Risk Assessment |
N/A |
HTML |
| Second Insults |
| Second Insults: Pre-hospital and Post-admission - Adult |
N/A |
HTML |
| Second Insults: Pre-hospital and Post-admission - Pediatric |
N/A |
HTML |
| Discharge Information |
| Discharge Status |
N/A |
HTML |
| ER Destination |
N/A |
HTML |
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Assessments and Examinations
Note: The data elements included in the modules labeled “Pediatric” were considered to be specific to pediatric TBI. However, the modules labeled “Adult” may also include elements relevant but not specific to pediatric TBI.
Assessments and Examinations
| CRF Module/Guideline by Sub-Domain |
Download |
CDEs |
| Vital Signs and Other Body Measures |
| ABC and Vital Signs on Admission - Adult |
N/A |
HTML |
| ABC and Vital Signs on Admission - Pediatric |
N/A |
HTML |
| Intracranial Pressure (ICP) Monitoring - Adult |
N/A |
HTML |
| Intracranial Pressure (ICP) Monitoring - Pediatric |
N/A |
HTML |
| Vital Signs and Blood Gases Daily/Hourly - Adult |
N/A |
HTML |
| Vital Signs and Blood Gases Daily/Hourly - Pediatric |
N/A |
HTML |
| Physical/Neurological Examination |
| Neurological assessment: GCS and Pupils - Adult |
N/A |
HTML |
| Neurological assessment: GCS and Pupils - Pediatric |
N/A |
HTML |
| Neurological Assessment: Neuroworsening - Adult |
N/A |
HTML |
| Neurological assessment: Neuroworsening - Pediatric |
N/A |
HTML |
| Neurological Assessment: LOC, PTA, and AOC |
N/A |
HTML |
| Laboratory Tests and Biospecimens/Biomarkers |
| Laboratory Tests - Adult |
N/A |
HTML |
| Laboratory Tests - Pediatric |
N/A |
HTML |
| Recommendations for CDEs for Biospecimens and Biomarkers |
29KB DOC |
N/A |
| Plasma and Serum Guidelines for Proteomic Analysis (Table 2) |
94KB DOC |
N/A |
| Cerebral Spinal Fluid Guidelines (Table 3) |
45KB DOC |
N/A |
| Cerebral Microdialysis Guidelines (Table 4) |
35KB DOC |
N/A |
| DNA Guidelines for Genomic Analysis (Table 1) |
38KB DOC |
N/A |
| Imaging Diagnostics |
| Pathoanatomic Terms for Definitions of TBI Lesions and Associated Findings (Appendix I) |
106KB DOC |
HTML |
| Imaging Parameters for MRI and Protocols for MRI and CT (Appendix II) |
179KB DOC |
N/A |
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Treatment/Intervention Data
Note: The data elements included in the modules labeled “Pediatric” were considered to be specific to pediatric TBI. However, the modules labeled “Adult” may also include elements relevant but not specific to pediatric TBI.
Treatment/Intervention Data
| CRF Module/Guideline by Sub-Domain |
Download |
CDEs |
| Drugs |
| Concomitant Medications - Adult |
N/A |
HTML |
| Concomitant Medications - Pediatric |
N/A |
HTML |
| Surgeries and Other Procedures |
| ER/Admission Therapeutic Procedures - Adult |
N/A |
HTML |
| ER/Admission Therapeutic Procedures - Pediatric |
N/A |
HTML |
| Surgical Therapy |
N/A |
HTML |
| Therapies |
| Post Discharge/Outpatient Treatment - Adult |
N/A |
HTML |
| Post Discharge/Outpatient Treatment - Pediatric |
N/A |
HTML |
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Protocol Experience
The General CDE Standards contain useful CRF Modules and CDEs for this domain.
Safety Data
The General CDE Standards contain useful CRF Modules and CDEs for this domain.
Outcomes and End Points
NOTE: The CDEs from copyright-protected measures are intentionally excluded from this site. 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 |
| Summary of All Outcome Recommendations |
| Outcome Domains and Descriptions |
43KB DOC |
N/A |
| CDE Recommendations - Listing of the Core, Supplemental and Emerging Measures for each Outcome Domain |
63KB DOC |
N/A |
| Psychometric Properties of the Recommended TBI Outcome CDEs in Core and Supplemental Tiers |
692KB DOC |
N/A |
| Global Outcome |
| CDE Recommendations for Global Outcome |
44KB XLS |
HTML |
| Disability Rating Scale (DRS) |
60KB DOC |
HTML |
| Mayo-Portland Adaptability Inventory-4 (MPAI-4) |
44KB PDF |
HTML |
| Academics |
| CDE Recommendations for Academics |
38KB XLS |
N/A |
| Adaptive and Daily Living Skills |
| CDE Recommendations for Adaptive and Daily Living Skills |
48KB XLS |
N/A |
| Behavioral Function |
| CDE Recommendations for Behavioral Function |
25KB XLS |
N/A |
| Clinical Event End Points |
| Death |
N/A |
HTML |
| Cognitive Activity Limitations |
| CDE Recommendations for Cognitive Activity Limitations |
26KB XLS |
N/A |
| Family and Environment |
| CDE Recommendations for Family and Environment |
38KB XLS |
N/A |
| Infant and Toddler Measures |
| CDE Recommendations for Infant and Toddler Measures |
36KB XLS |
N/A |
| Language and Communication |
| CDE Recommendations for Language and Communication |
46KB XLS |
N/A |
| Neuropsychological Impairment |
| CDE Recommendations for Neuropsychological Impairment |
85KB XLS |
HTML |
| Physical Function |
| CDE Recommendations for Physical Function |
51KB XLS |
N/A |
| Post-concussive/TBI Symptoms |
| CDE Recommendations for Post-concussive/TBI Symptoms |
32KB XLS |
HTML |
| Psychological Status |
| CDE Recommendations for Psychological Status |
39KB XLS |
HTML |
| Substance Abuse Questions from the TBI Model System Dataset |
59KB DOC |
HTML |
| Alcohol, Smoking, and Substance Use Involvement Screening Test (ASSIST) |
82KB PDF |
HTML |
| The Alcohol Use Disorders Identification Test: Self-Report Version (AUDIT) |
62KB DOC |
HTML |
| PTSD Checklist - Civilian (PCL-C) |
74KB DOC |
HTML |
| PTSD Checklist - Military (PCL-M) |
74KB DOC |
HTML |
| PTSD Checklist - Stressor Specific (PCL-S) |
75KB DOC |
HTML |
| Psychiatric and Psychological Functions |
| CDE Recommendations for Psychiatric and Psychological Functions |
46KB XLS |
N/A |
| Quality of Life |
| CDE Recommendations for Perceived Generic and Disease-Specific Health-Related Quality of Life |
35KB XLS |
HTML |
| CDE Recommendations for Health-economic Measures |
27KB XLS |
N/A |
| CDE Recommendations for Patient Reported Outcomes |
30KB XLS |
N/A |
| Recovery of Consciousness |
| CDE Recommendations for Recovery of Consciousness |
29KB XLS |
HTML |
| Social Cognition |
| CDE Recommendations for Social Cognition |
31KB XLS |
N/A |
| Social Role Participation |
| CDE Recommendations for Social Role Participation |
48KB XLS |
N/A |
| Participation Assessment with Recombined Tools-Objective (PART) |
103KB DOC |
HTML |
| Craig Handicap and Assessment Reporting Technique (CHART-SF) |
67KB DOC |
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:
In civilian, military and Veteran populations, there is an increased recognition
of the interrelationship between traumatic brain injury (TBI) and some psychological
health (PH) disorders, and of the need to better understand the relationships by
integrating research on these topics.
The use of different measures to assess similar study variables and/or differing
metrics to assess outcomes may limit important advances in PH and TBI research.
Without a common set of data elements (which include variable definitions and recommended
measures), comparison of findings across studies is challenging.
To develop the TBI CDE standards a variety of
Co-sponsoring Federal agencies led a scientific initiative to develop
common data elements for TBI. Scientific experts were invited to participate
in working groups to develop recommendations
for specific topic-driven common data elements. The draft recommendations were presented
and discussed in a workshop, “Advancing Integrated Research in Psychological Health
and Traumatic Brain Injury: Common Data Elements (CDE)” held on March 23–24, 2009,
in Silver Spring, Maryland. The overall process leading to the workshop and the
subsequent recommendations by the working groups are published in the
Archives of Physical Medicine and Rehabilitation.
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 are organized into domains which are intuitive and common in clinical
research studies.
The original TBI CDE recommendations were formulated using three general descriptive
levels - core, supplemental and
emerging – which were intended to provide further description to the recommendations
and use of data elements. Data elements described as core are intended to encompass
the minimal set of measures to characterize a broad spectrum of subjects on the
domain. A supplemental element is one intended for greater depth/breadth of exploration
and/or intended for more specialized subpopulations. Data elements described as
emerging are those that may require further validation but may fill gaps in currently
validated measures and/or substitute for recommended measures once validation is
complete. Please note that in order to be consistent with the classification of
other NINDS CDEs on this site, the term “emerging” has been replaced with the synonymous
term “exploratory”.
The TBI CDEs only include an abridged version of the recommendations of the
Demographics and Clinical Assessment Working Group. That Working Group presented
its CDE recommendations using three levels of detail: Basic, Intermediate and Advanced,
with the greatest level of detail in the Advanced version. This Web site currently
only includes the Basic level of detail. For a complete listing of all Demographic
and Clinical Assessment CDEs and modular CRFs, please see the IMPACT
Web site. Additional CDEs and CRF Modules will be added to this site once
beta testing of the TBI CDEs is complete.
Co-Sponsoring Federal Agencies
The Federal Liaisons and Consultants for the TBI CDE Project have formed four new
working groups to build upon the success of the first set of recommendations (i.e.,
TBI CDEs Version 1.0). The goal is to expand the list of definitions to fill gaps,
to update some of the recommendations based on the “beta-testing”, and to organize
the CDEs in modules to make them easier to use. The committees working on TBI CDEs
Version 2.0 are shown directly below. Also included below is an archived version
of the original working group members who were responsible for creating Version
1.0 of the TBI CDEs.
Complete Version 2.0 Traumatic Brain Injury CDE Working Group Roster
Federal Liaisons and Consultants
- Beth M. Ansel, PhD, CCC-SLP - National Center for Medical Rehabilitation Research, The Eunice Kennedy Shriver National Institute of Child Health and Human Development
- Victor G. Coronado, MD - National Center for Injury Prevention and Control, Centers for Disease Control and Prevention
- Thomas J. DeGraba, MD, FAHA - National Intrepid Center of Excellence
- Alison Garcia - Sapient
- Douglas B. Gibson, PhD - U.S. Army Medical Research and Materiel Command, Combat Casualty Care Research Program
- Ramona Hicks, PhD - National Institute of Neurological Disorders and Stroke, National Institutes of Health
- Stuart W. Hoffman, PhD - Office of Research and Development, U.S. Department of Veterans Affairs
- Geoffrey T. Manley, MD, PhD - University of California, San Francisco, San Francisco General Hospital, Brain and Spinal Injury Center
- Matthew McAuliffe, PhD - Center for Information Technology, National Institutes of Health
- A. Cate Miller, PhD - National Institute on Disability and Rehabilitation Research, U.S. Department of Education
- Joanne Odenkirchen, MPH - National Institute of Neurological Disorders and Stroke, National Institutes of Health
- Ross H. Pastel, PhD - National Intrepid Center of Excellence, National Naval Medical Center
- Lt. Wanda Salzer - Defense Centers of Excellence for Psychological Health and Traumatic Brain Injury
- Karen Schwab, PhD - Defense and Veterans Brain Injury Center, Walter Reed Army Medical Center
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Core CDEs and Epidemiology Subgroup
- Cindy Harrison-Felix, PhD - Craig Hospital, Chair
- Davida M. Carr, MPH - HJF Contractor for Defense and Veterans Brain Injury Center/Defense Centers of Excellence
- Wayne A. Gordon, PhD, ABPP/Cn - Department of Rehabilitation Medicine, Mount Sinai School of Medicine
- Harvey Levin, PhD - Baylor College of Medicine
- David K. Menon, MD, PhD - Division of Anaesthesia, University of Cambridge
- Jennie Ponsford, MA, PhD - School of Psychology and Psychiatry, Monash University
- Karen Schwab, PhD - Defense and Veterans Brain Injury Center, Walter Reed Army Medical Center
- Grahame Simpson, PhD - Brain Injury Rehabilitation Unit
- Hilaire J. Thompson, PhD, RN, CNRN, FAAN - Biobehavioral Nursing and Health Systems, School of Nursing, University of Washington
- Pieter E. Vos, MD, PhD - Department of Neurology, Radboud University Nijmegen Medical Centre
- Jerry Wright, MS, CBIST - Rehabilitation Research Center, Santa Clara Valley Medical Center
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Concussion/Mild TBI Subgroup
- Elisabeth Wilde, PhD - Departments of Physical Medicine and Rehabilitation, Neurology and Radiology, Baylor College of Medicine, Chair
- Vicki Anderson, PhD - Integrated Mental Health Program, Royal Children's Hospital
- Victor G. Coronado, MD - National Center for Injury Prevention and Control, Centers for Disease Control and Prevention
- Gavin Davis, MBBS - Cabrini Medical Centre
- Thomas J. DeGraba, MD, FAHA - National Intrepid Center of Excellence
- Sureyya Dikmen, PhD - Department of Rehabilitation Medicine, University of Washington
- Gerard A. Gioia, PhD - Children's National Medical Center, George Washington University School of Medicine
- Robin A. Hurley, MD - W. G. (Bill) Hefner VA Medical Center
- Grant L. Iverson, PhD - Department of Psychiatry, University of British Columbia
- Andy Jagoda, MD, FACEP - Department of Emergency Department, Mount Sinai School of Medicine
- Michael W. Kirkwood, PhD, ABPP/CN - University of Colorado Denver School of Medicine, Department of Physical Medicine & Rehabilitation
- Russell R. Lonser, MD - National Institute of Neurological Disorders and Stroke, National Institutes of Health
- Geoffrey T. Manley, MD, PhD - University of California, San Francisco, San Francisco General Hospital, Brain and Spinal Injury Center
- Jeffrey Max, MD - Department of Psychiatry, University of California, San Diego & Director
- Thomas W. McAllister, MD - Dartmouth-Hitchcock Psychiatric Associates
- Michael McCrea, PhD, ABPP - Departments of Neurosurgery and Neurology, Medical College of Wisconsin
- Paul McCrory, MBBS, PhD - Melbourne School of Health Sciences
- Pratik Mukherjee, MD, PhD - Department of Radiology, University of California, San Francisco
- Douglas C. Oberly, MS - BrainScope Company, Inc.
- Ross H. Pastel, PhD - National Intrepid Center of Excellence, National Naval Medical Center
- Leslie S. Prichep, PhD - Brain Research Laboratories, Department of Psychiatry, New York University School of Medicine
- Michael E. Singer, PhD - BrainScope Company, Inc.
- Keith O. Yeates, PhD - The Research Institute at Nationwide Children's Hospital
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Acute Hospitalized Subgroup
- Alex Valadka, MD, FAANS, FACS - Seton Brain and Spine Institute, Chair
- Rachel P. Berger, MD, MPH - Child Advocacy Center, Children's Hospital of Pittsburgh of University of Pittsburgh Medical Center
- Ann-Christine Duhaime, MD - Massachusetts General Hospital
- Ronald L. Hayes, PhD - Center of Innovative Research, Banyan Biomarkers, Inc.
- Ramona Hicks, PhD - National Institute of Neurological Disorders and Stroke, National Institutes of Health
- Jamie Hutchison, MD - The Hospital for Sick Children
- Andrew I.R. Maas, MD, PhD - Department of Neurosurgery, University Hospital of Antwerp
- David K. Menon, MD, PhD - Division of Anaesthesia, University of Cambridge
- Jose A. Pineda, MD, MSc - Department of Pediatrics and Neurology, Washington University School of Medicine
- Robert D. Stevens, MD - Departments of Anesthesiology/Critical Care Medicine, Neurology, Neurosurgery, and Radiology, The Johns Hopkins University School of Medicine, Division of Neurosciences Critical Care
- Willie Stewart, MBChB, PhD - Department of Neuropathology, Institute of Neurological Sciences, Southern General Hospital
- Nino Stocchetti, MD - University of Milan
- Monica S. Vavilala, MD - Harborview Injury Prevention and Research Center
- David W. Wright, MD, FACEP - Department of Emergency Medicine, Emory University School of Medicine
- Esther L. Yuh, MD, PhD - University of California, San Francisco
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Moderate/Severe TBI: Rehabilitation Subgroup
- Joseph T. Giacino, PhD - Spaulding Rehabilitation Hospital, Department of Physical Medicine and Rehabilitation, Harvard Medical School, Chair
- Beth M. Ansel, PhD, CCC-SLP - National Center for Medical Rehabilitation Research, The Eunice Kennedy Shriver National Institute of Child Health and Human Development
- Kathleen R. Bell, MD - Department of Rehabilitation Medicine, University of Washington
- Tamara Bushnik, PhD, FACRM - Department of Rehabilitation Medicine, Rusk Institute for Rehabilitation
- David X. Cifu, MD - Department of Physical Medicine and Rehabilitation, Virginia Commonwealth University, Physical Medicine and Rehabilitation Program Office, U.S. Department of Veterans Affairs
- Linda Ewing-Cobbs, PhD - Dan L Duncan Children's Neurodevelopmental Clinic, Children's Learning Institute
- Tessa Hart, PhD - Moss Rehabilitation Research Institute
- Stuart W. Hoffman, PhD - Office of Research and Development, U.S. Department of Veterans Affairs
- Stephanie A. Kolakowsky-Hayner, PhD, CBIST - Rehabilitation Research Center, Santa Clara Valley Medical Center
- Steven Laureys, MD, PhD - University Hospital of Liège
- A. Cate Miller, PhD - National Institute on Disability and Rehabilitation Research, U.S. Department of Education
- Jennie Ponsford, MA, PhD - School of Psychology and Psychiatry, Monash University
- Louis Puybasset, MD, PhD - The Pitié-Salpêtrière Hospital
- M. Elizabeth Sandel, MD - Kaiser Foundation Rehabilitation Center
- David S. Tulsky, PhD - University of Michigan, North Campus Research Complex
- Shari Wade, PhD - UC Department of Pediatrics, Cincinnati Children's Hospital Medical Center
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NINDS CDE Team
- Stacie Grinnon, MS - KAI Research, Inc. (An Altarum Company), Rockville, Maryland, USA
- Ramona Hicks, PhD - 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)
- Amy Price, MS - KAI Research, Inc. (An Altarum Company), Rockville, Maryland, USA
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The TBI CDE version 1.0 Working Group initiative involved an Interagency Planning
Committee, TBI working groups, and PH working groups. The working groups focused
on developing specific topic-driven CDEs. Each working group actively developed
the CDEs for their specific topic and also had an opportunity to review and comment
on the recommendations of the other working groups. After the TBI CDEs were drafted,
an Interagency Steering Committee and an Implementation Group were formed to provide
oversight and guidance for managing and updating the TBI-specific data elements.
The complete version 1.0 TBI CDE Working Group roster can be viewed below.
Complete Version 1.0 Traumatic Brain Injury CDE Working Group Roster
Note: Institutions for all individuals acknowledged in this section
were those they belonged to when they joined the Working Group. All Working Group
members were asked to voluntarily disclose all potential sources of bias in their
involvement with the NINDS CDE Project. The summary disclosure information is available
upon request by contacting NINDSCommonData@kai-research.com.