NINDS Common Data Elements Harmonizing information. Streamlining research.

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 TBI CDE CRF modules, instrument recommendations, and guideline documents for the study type selected can be downloaded below.

Download Comprehensive CDE Recommendations

The outline that follows includes all of the CDE data associated with the CRF modules and instrument recommendations, organized by study type, domain, and sub-domain. Choose your type of TBI study (Acute Hospitalized, Concussion/Mild TBI, Moderate/Severe TBI: Rehabilitation, or Epidemiology) or Comprehensive if your study falls outside of the study types or incorporates aspects of more than one type of study and then browse the resulting outline.

Comprehensive Acute Hospitalized Concussion/Mild TBI Moderate/Severe TBI: Rehabilitation Epidemiology

Please note that the Comprehensive template CRFs include the Core CDEs and CDEs Basic to at least one of the study types. Additional Supplemental CDEs are listed for possible inclusion at the bottom of the template CRFs. Recommended proprietary instruments/scales are included on this page regardless of classification. For the classifications assigned to instruments/scales, please see the Table of Recommended Outcome Measures. The classifications used in the TBI CDEs are described in the TBI CDE Overview.

Participant/Subject Characteristics

Participant/Subject Characteristics

CRF Module/Guideline by Sub-Domain	Download	CDEs	© or TM
Demographics
Demographics	49KB DOC	HTML
Social Status
Socioeconomic Status	84KB DOC	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
Significant Medical History	56KB DOC	HTML
Behavioral History	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
Definition of Traumatic Brain Injury	32KB DOC	N/A
Ohio State University TBI Identification Method Short Form	NOC	HTML
Screening for TBI in Military Personnel	63KB PDF	HTML
Injury Presentation - Early/Late	62KB DOC	HTML
Type, Place, Cause and Mechanism of Injury	72KB DOC	HTML
Classification
Injuries and Injury Severity	58KB DOC	HTML
Baseline Risk Assessment	N/A	HTML
Second Insults
Second Insults and Other Complications	60KB DOC	HTML
Discharge Information
Discharge Status	60KB DOC	HTML
ER Destination	58KB DOC	HTML

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Assessments and Examinations

Assessments and Examinations

CRF Module/Guideline by Sub-Domain	Download	CDEs	© or TM
Physical/Neurological Examination
Neurological Assessment: Glasgow Coma Scale (GCS) and Pupils	57KB DOC	HTML
Neurological Assessment: LOC, PTA, and AOC	58KB DOC	HTML
Neurological Assessment: TBI Symptoms and Signs	58KB DOC	HTML
Hearing	N/A	HTML
Balance	N/A	HTML
Vital Signs and Other Body Measures
Height and Weight	N/A	HTML
Vital Signs and Blood Gases	42KB DOC	HTML
Intracranial Pressure (ICP) Monitoring	N/A	HTML
Laboratory Tests and Biospecimens/Biomarkers
Laboratory Tests	98KB DOC	HTML
Recommendations for CDEs for Biospecimens and Biomarkers	29KB DOC	N/A
DNA Guidelines for Genomic Analysis (Table 1)	38KB 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
TBI Biospecimen Collection Protocol SAMPLE	1999KB DOC	N/A
Imaging Diagnostics
Imaging	103KB DOC	HTML
Pathoanatomic Terms for Definitions of TBI Lesions and Associated Findings (Appendix I)	106KB DOC	N/A
Imaging Parameters for MRI and Protocols for MRI and CT (Appendix II)	179KB DOC	N/A

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Treatment/Intervention Data

Treatment/Intervention Data

CRF Module/Guideline by Sub-Domain	Download	CDEs	© or TM
Drugs Note: The General CDE Standards contain additional useful CRF Modules and CDEs for this category of data.
Prior and Concomitant Medications	N/A	HTML
Surgeries and Other Procedures
ER/Admission Therapeutic Procedures	42KB DOC	HTML
Surgical and Therapeutic Procedures	N/A	HTML
Intraoperative Management	N/A	HTML
Therapies
Therapy Intensity Level	N/A	HTML
Post Discharge/Outpatient Treatment	70KB DOC	HTML

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Protocol Experience

The General CDE Standards contain useful CRF Modules and CDEs for this domain.

Protocol Experience

CRF Module/Guideline by Sub-Domain	Download	CDEs	© or TM
Participant/Subject Identification, Eligibility, and Enrollment
Informed Consent	42KB DOC	HTML
Off Treatment/Off Study
Study Discontinuation/Completion	N/A	HTML

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Safety Data

The General CDE Standards contain useful CRF Modules and CDEs for this domain.

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
Summary of All Outcome Measure Recommendations
Outcome Measure Domains Descriptions	49KB DOC	N/A
Table of Recommended Outcome Measures	60KB XLS	N/A
Psychometric Properties of Selected Outcome Measures	698KB DOC	N/A
Global Outcome
Summary of Recommendations for Global Outcome	81KB DOC	N/A
Disability Rating Scale (DRS)	952KB PDF	HTML
Glasgow Outcome Scale (GOS)	40KB DOC	HTML
Glasgow Outcome Scale Extended (GOSE)	66KB DOC	HTML
Glasgow Outcome Scale Extended (GOSE) Pediatric Revision	43KB DOC	HTML
Mayo-Portland Adaptability Inventory-4 (MPAI-4)	1576KB PDF	HTML
Academics
Summary of Recommendations for Academics	80KB DOC	N/A
Adaptive and Daily Living Skills
Summary of Recommendations for Adaptive and Daily Living Skills	81KB DOC	N/A
Mayo-Portland Adaptability Inventory-4 (MPAI-4)	1576KB PDF	HTML
Behavioral Function
Summary of Recommendations for Behavioral Function	51KB DOC	N/A
Cognitive Activity Limitations
Summary of Recommendations for Cognitive Activity Limitations	56KB DOC	N/A
Deafness and Communication Disorders
Summary of Recommendations for Deafness and Communication Disorders	145KB DOC	N/A
Effort/Symptom Validity
Summary of Recommendations for Effort/Symptom Validity	62KB DOC	N/A
Family and Environment
Summary of Recommendations for Family and Environment	70KB DOC	N/A
Family Assessment Device (FAD)	18KB PDF	HTML
Health-Economic Measures
Summary of Recommendations for Health-Economic Measures	52KB DOC	N/A
Infant and Toddler Measures
Summary of Recommendations for Infant and Toddler Measures	76KB DOC	N/A
Language and Communication
Summary of Recommendations for Language and Communication	104KB DOC	N/A
Military Studies
Summary of Recommendations for Military Studies	57KB DOC	N/A
Military Acute Concussion Evaluation (MACE)	633KB PDF	HTML
Neuropsychological Impairment
Summary of Recommendations for Neuropsychological Impairment	162KB DOC	N/A
Patient Reported Outcomes
Summary of Recommendations for Patient Reported Outcomes (Future Multidimensional Tools)	58KB DOC	N/A
Perceived Generic and Disease-Specific Health-Related Quality of Life
Summary of Recommendations for Perceived Generic and Disease-Specific Health-Related Quality of Life	61KB DOC	N/A
Satisfaction with Life Scale	25KB DOC	HTML
Physical Function
Summary of Recommendations for Physical Function	102KB DOC	N/A
Post-concussive/TBI-Related Symptoms
Summary of Recommendations for Post-concussive/TBI-Related Symptoms	63KB DOC	N/A
Health and Behavior Inventory (HBI) Child Version	33KB DOC	HTML
Health and Behavior Inventory (HBI) Parent Current Version	32KB DOC	HTML
Health and Behavior Inventory (HBI) Parent Retrospective Version	32KB DOC	HTML
Neurobehavioral Symptom Inventory	73KB PDF	HTML
Psychiatric and Psychological Status
Summary of Recommendations for Psychiatric and Psychological Status	DOC	N/A
Alcohol, Smoking, and Substance Use Involvement Screening Test (ASSIST)	314KB PDF	HTML
Alcohol Use Disorders Identification Test: Self-Report Version (AUDIT)	172KB PDF	HTML
Center for Epidemiologic Studies-Depression Scale (CES-D)	8KB PDF	HTML
Family Assessment Device (FAD)	18KB PDF	HTML
Patient Health Questionnaire - 9 (PHQ-9)	39KB PDF	HTML
PTSD Checklist - Civilian (PCL-C)	816KB PDF	HTML
PTSD Checklist - Military (PCL-M)	816KB PDF	HTML
PTSD Checklist - Stressor Specific (PCL-S)	816KB PDF	HTML
Substance Abuse Questions from the TBI Model Systems Database	114KB PDF	HTML
Recovery of Consciousness/Memory Recovery
Summary of Recommendations for Recovery of Consciousness/Memory Recovery	56KB DOC	N/A
Galveston Orientation and Amnesia Test (GOAT)	24KB PDF	HTML
JFK Coma Recovery Scale- Revised	249KB PDF	HTML
Social Cognition
Summary of Recommendations for Social Cognition	62KB DOC	N/A
Social Role Participation and Social Competence
Summary of Recommendations for Social Role Participation and Social Competence	96KB DOC	N/A
Craig Handicap and Assessment Reporting Technique (CHART-SF)	543KB PDF	HTML
Participation Assessment with Recombined Tools-Objective (PART)	339KB PDF	HTML
Sports-Related Studies
Summary of Recommendations for Sports-Related Studies	64KB DOC	N/A
End Points
Post Discharge Status	59KB DOC	HTML
Death	42KB DOC	HTML

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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, 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 a Working Group to develop recommendations for specific topic-driven common data elements. The resulting TBI CDE Version 1.0 recommendations were published in the Archives of Physical Medicine and Rehabilitation in November 2010. Additional pediatric-specific recommendations were developed and published in The Journal of Neurotrama in March 2012.

The Working Group reconvened in late 2011 to refine and reorganize the CDEs according to type of TBI study (Concussion/mild TBI studies, Acute Hospitalized studies, Moderate/Severe TBI: Rehabilitation studies, and Epidemiology studies), reduce the list of “Core” CDEs strongly recommended for NINDS-funded studies, and expand the CDEs to be more comprehensive and fill gaps. Version 2.0 of the TBI CDEs was published on this site in late June 2012 and was used to construct the Federal Interagency Traumatic Brain Injury Research informatics system, which was available for use in mid-July 2012.

Version 2.0 includes 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. Investigators can choose from this catalog of CDEs when assembling their clinical study materials. The Version 2.0 CDEs are classified according to the following definitions:

• Core - small set of data elements that are relevant to all TBI clinical studies
• Basic – small set of data elements, beyond the Core, that are recommended for inclusion in studies of Concussion/mild TBI, Acute Hospitalized, Moderate/Severe TBI: Rehabilitation, or Epidemiology
• Supplemental – additional recommended data elements where inclusion depends upon the particulars of the study

Researchers working on acute hospitalized, concussion or mild TBI, rehabilitation of moderate or severe TBI, and epidemiology studies can use these classifications as guidelines to find customized sets of elements that they can incorporate into their studies.

Please note the Version 1.0 TBI CDE recommendations of the Demographics and Clinical Assessment Working Group are available on the IMPACT Web site. These CDE recommendations are presented using an alternate classification scheme of three levels of detail: Basic, Intermediate and Advanced, with the greatest level of detail in the Advanced version.

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
• Kenneth C. Curley, MD - US Army Medical Research and Materiel Command
• 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
• Col. Wanda Salzer - US Army Medical Research and Materiel Command
• 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

• 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)
• Joshua Hagel - The EMMES Corporation, Rockville, Maryland, USA (2013 - present)
• Angela Soriano - The EMMES Corporation, Rockville, Maryland, USA (2013 - present)
• Pamela West - The EMMES Corporation, Rockville, Maryland, USA (2013 - present)
• Stacie Grinnon, MS - KAI Research, Inc. (An Altarum Company), Rockville, Maryland, USA (2007 - 2012)
• Amy Price, MS - KAI Research, Inc. (An Altarum Company), Rockville, Maryland, USA (2007 - 2012)

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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 NINDSCDE@emmes.com.

The NINDS Common Data Element Project is committed to creating useful tools for the neurological research community. To send questions, comments, or concerns regarding the Project, please fill out the form below. Thank you in advance for your feedback! Required fields are marked with Feedback Form Topic What your comments/questions primarily pertain to: Content of CDEs Overall NINDS CDE Project Web Site Other Subject Field is limited to 50 characters. Comments/Questions Field is limited to 5000 characters. Contact Information First Name Last Name Suffix Title Email

Publications in the Archives of Physical Medicine and Rehabilitation

• Duhaime AC, Gean AD, Haacke EM, Hicks R, Wintermark M, Mukherjee P, Brody D, Latour L, Riedy G; Common Data Elements Neuroimaging Working Group Members, Pediatric Working Group Members. Common data elements in radiologic imaging of traumatic brain injury. Arch Phys Med Rehabil. 2010 Nov;91(11):1661-6. PubMed PMID: 21044709.
• Kaloupek DG, Chard KM, Freed MC, Peterson AL, Riggs DS, Stein MB, Tuma F. Common data elements for posttraumatic stress disorder research. Arch Phys Med Rehabil. 2010 Nov;91(11):1684-91. PubMed PMID: 21044712.
• Maas AI, Harrison-Felix CL, Menon D, Adelson PD, Balkin T, Bullock R, Engel DC, Gordon W, Orman JL, Lew HL, Robertson C, Temkin N, Valadka A, Verfaellie M, Wainwright M, Wright DW, Schwab K. Common data elements for traumatic brain injury: recommendations from the interagency working group on demographics and clinical assessment. Arch Phys Med Rehabil. 2010 Nov;91(11):1641-9. PubMed PMID: 21044707.
• Manley GT, Diaz-Arrastia R, Brophy M, Engel D, Goodman C, Gwinn K, Veenstra TD, Ling G, Ottens AK, Tortella F, Hayes RL. Common data elements for traumatic brain injury: recommendations from the biospecimens and biomarkers working group. Arch Phys Med Rehabil. 2010 Nov;91(11):1667-72. PubMed PMID: 21044710.
• Menon DK, Schwab K, Wright DW, Maas AI; Demographics and Clinical Assessment Working Group of the International and Interagency Initiative toward Common Data Elements for Research on Traumatic Brain Injury and Psychological Health. Position statement: definition of traumatic brain injury. Arch Phys Med Rehabil. 2010 Nov;91(11):1637-40. PubMed PMID: 21044706.
• Nash WP, Vasterling J, Ewing-Cobbs L, Horn S, Gaskin T, Golden J, Riley WT, Bowles SV, Favret J, Lester P, Koffman R, Farnsworth LC, Baker DG. Consensus recommendations for common data elements for operational stress research and surveillance: report of a federal interagency working group. Arch Phys Med Rehabil. 2010 Nov;91(11):1673-83. PubMed PMID: 21044711.
• Thurmond VA, Hicks R, Gleason T, Miller AC, Szuflita N, Orman J, Schwab K. Advancing integrated research in psychological health and traumatic brain injury: common data elements. Arch Phys Med Rehabil. 2010 Nov;91(11):1633-6. PubMed PMID: 21044705.
• Whyte J, Vasterling J, Manley GT. Common data elements for research on traumatic brain injury and psychological health: current status and future development. Arch Phys Med Rehabil. 2010 Nov;91(11):1692-6. PubMed PMID: 21044713.
• Wilde EA, Whiteneck GG, Bogner J, Bushnik T, Cifu DX, Dikmen S, French L, Giacino JT, Hart T, Malec JF, Millis SR, Novack TA, Sherer M, Tulsky DS, Vanderploeg RD, von Steinbuechel N. Recommendations for the use of common outcome measures in traumatic brain injury research. Arch Phys Med Rehabil. 2010 Nov;91(11):1650-1660.e17. PubMed PMID: 21044708.

Publications in the Journal of Neurotrauma

• Adelson PD, Pineda J, Bell MJ, Abend NS, Berger RP, Giza CC, Hotz G, Wainwright M. Common Data Elements for Pediatric Traumatic Brain Injury: Recommendations from the Working Group on Demographics and Clinical Assessment. J Neurotrauma. 2012 March; 29: 639-653. PubMed PMID: 21939389.
• Berger RP, Beers SR, Papa L, Bell M. Common Data Elements for Pediatric Traumatic Brain Injury: Recommendations from the Biospecimens and Biomarkers Workgroup. J Neurotrauma. 2012 March; 29: 672-677. PubMed PMID: 22106839.
• Duhaime AC, Holshouser B, Hunter JV, Tong K. Common Data Elements for Neuroimaging of Traumatic Brain Injury: Pediatric Considerations. J Neurotrauma. 2012 March; 29: 629-633. PubMed PMID: 21671798.
• Gerring JP, Wade S. The Essential Role of Psychosocial Risk and Protective Factors in Pediatric TBI Research. J Neurotrauma. 2012 March; 29: 621-628. PubMed PMID: 22091875.
• Hunter JV, Wilde EA, Tong KA, Holshouser BA. Emerging Imaging Tools for Use with Traumatic Brain Injury Research. J Neurotrauma. 2012 March; 29: 654-671. PubMed PMID: 21787167.
• Maas AI, Harrison-Felix CL, Menon D, Adelson PD, Balkin T, Bullock R, Engel DC, Gordon W, Langlois-Orman J, Lew HL, Robertson C, Temkin N, Valadka A, Verfaellie M, Wainwright M, Wright DW, Schwab K. Standardizing data collection in traumatic brain injury. J Neurotrauma. 2011 Feb;28(2):177-87. Epub 2011 Feb 5. PubMed PMID: 21162610.
• McCauley SR, Wilde EA, Anderson VA, Bedell G, Beers SR, Campbell TF, Chapman SB, Ewing-Cobbs L, Gerring JP, Gioia GA, Levin HS, Michaud LJ, Prasad MR, Swaine BR, Turkstra LS, Wade SL, Yeates KO. Recommendations for the Use of Common Outcome Measures in Pediatric Traumatic Brain Injury Research. J Neurotrauma. 2012 March; 29: 678-705. PubMed PMID: 21644810.
• Miller AC, Odenkirchen J, Duhaime AC, Hicks R. Common Data Elements for Research on Traumatic Brain Injury - Pediatric Considerations. J Neurotrauma. 2012 March; 29: 634-638. PubMed PMID: 22091862.

Additional Publications

• Haacke EM, Duhaime AC, Gean AD, Riedy G, Wintermark M, Mukherjee P, Brody DL, DeGraba T, Duncan TD, Elovic E, Hurley R, Latour L, Smirniotopoulos JG, Smith DH. Common data elements in radiologic imaging of traumatic brain injury. J Magn Reson Imaging. 2010 Sep;32(3):516-43. PubMed PMID: 20815050.
• Miller G. Neuroscience. New guidelines aim to improve studies of traumatic brain injury. Science 328:297 (2010). PubMed PMID: 20395488.
• Traumatic brain injury: time to end the silence. The Lancet Neurology, Vol. 9, No. 4. (April 2010), pp. 331. PubMed PMID: 20298955.

Sample Protocols

• 1a. TBI Biospecimen Collection Sample Protocol 
• 1b. TBI Site Specimen Log 

Version 2.01 of the TBI CDEs replaced Version 2.0 on this site in April 2013. The document below describes the revisions incorporated in Version 2.01 compared to Version 2.0. Please contact NINDSCDE@emmes.com if you require further information or have any questions about the revision history.

TBI CDEs Revision History - April 2013