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.
• Recommended Instruments spreadsheets with details (descriptions, scoring, references, etc.) for all recommended proprietary instruments/ scales/ tests. If proprietary instruments/scales/tests are made available for use, they are populated in the table below.

For your reference, a zip file containing all of the Stroke CDE CRF modules can be downloaded below.

Download Stroke 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	89KB DOC	HTML
Social Status
Social Status	67KB 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
Medical History	207KB DOC	HTML
Family History	64KB DOC	HTML
Behavioral History	113KB DOC	HTML
Pregnancy and Perinatal History	71KB DOC	HTML
History Data Source and Reliability	64KB DOC	HTML
Prior Health Status
Prior Functional Status	59KB DOC	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
Pre-Hospital/Emergency Medical Service (EMS) Course	53KB DOC	HTML
Hospital Arrival/Admission	62KB DOC	HTML
Stroke Symptoms/Comorbid Events	204KB DOC	HTML
Glasgow Coma Scale (GCS)	77KB PDF	HTML
Classification
Stroke Types and Subtypes	181KB DOC	HTML
Discharge Information
Hospital Discharge	53KB 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
Physical/Neurological Exam Note: Also refer to Outcomes and End Points for additional measures recommended for assessing neurological impairment and functional status.	87KB DOC	HTML
Vital Signs and Other Body Measures
Vital Signs	73KB DOC	HTML
Laboratory Tests and Biospecimens/Biomarkers
NINDS Repository Cerebrovascular Data Elements	NINDS-Coriell	N/A
Laboratory Tests	331KB DOC	HTML
Laboratory Tests Permissible Values for Stroke	107KB XLS	N/A
Biospecimen Collection and Processing	104KB DOC	HTML
Biomarker Guidelines	PDF	N/A
Imaging Diagnostics
Parenchymal Imaging	628KB DOC	HTML
Perfusion and Penumbral Imaging	98KB DOC	HTML
Vessel Carotid Ultrasound	144KB DOC	HTML
Vessel Imaging Angiography	635KB DOC	HTML
Vessel Imaging Transcranial Color-Coded Real-time Sonography (TCCS)	194KB DOC	HTML
Vessel Imaging Transcranial Doppler (TCD)	176KB DOC	HTML
Non-Imaging Diagnostics
Electrocardiogram (ECG)	71KB DOC	HTML

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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 sub-domain.
Prior and Concomitant Medications	121KB DOC	HTML
Antithrombotics and Risk Factor Controlling Medications	56KB DOC	HTML
Thrombolytic/Reperfusion Therapies	70KB DOC	HTML
Surgeries and Other Procedures
Surgical and Procedural Interventions	85KB DOC	HTML
Therapies
Lifestyle Modification Therapies	73KB DOC	HTML
Rehabilitation Therapies	103KB DOC	HTML
Palliative/Comfort Care and End of Life Issues	53KB DOC	HTML

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Protocol Experience

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

Safety Data

Note: The General CDE Standards contain additional 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 Recommendations
Stroke CDE Instrument Recommendations by Outcome Domain and Classification	PDF	N/A
Neurological Impairment
Summary of Recommended Measures for Neurological Impairment	DOC	N/A
NIH Stroke Scale (NIHSS)	NOC	HTML
Activities of Daily Living/Performance
Quality of Life in Neurological Disorders (Neuro-QOL)	NOC	N/A
National Institutes of Health (NIH) Toolbox	NOC	N/A
Post Acute Care Admission Continuity Assessment Record and Evaluation (PAC Admission CARE) Tool - Section VI: Functional Status	NOC	N/A
Patient-Reported Outcomes Measurement Information System (PROMIS)-Physical Function Assessments	NOC	N/A
Summary of Recommended Measures for Activities of Daily Living/Functional Status	DOC	N/A
Modified Rankin Scale (mRS)	NOC	HTML
Glasgow Outcome Scale (GOS) and Glasgow Outcome Scale - Extended (GOSE)	NOC	HTML
Emotional and Cognitive Status
Boston Naming Test (BNT) - 30-item version	NOC	N/A
Wechsler Adult Intelligence Scale III (WAIS-III) - Digit Symbol and Symbol Search subtests	NOC	N/A
Hopkins Verbal Learning Test – Revised (HVLT-R)	NOC	N/A
Montreal Cognitive Assessment (MoCA)	NOC	N/A
Neuropsychiatric Inventory (NPI) Questionnaire	NOC	N/A
Rey-Osterrieth Complex Figure Copy and Delay	NOC	N/A
Telephone Interview for Cognitive Status (TICS)	NOC	N/A
Summary of Recommended Measures for Emotional and Cognitive Status	DOC	N/A
Center for Epidemiologic Studies-Depression Scale (CES-D)	NOC	HTML
Informant Questionnaire on Cognitive Decline in the Elderly (IQCODE)	NOC	HTML
Delis Kaplan Executive Functioning System (DKEFS) - Trail Making Tests	NOC	N/A
Stroop Test	NOC	N/A
Woodcock-Johnson III Test of Cognitive Abilities	NOC	N/A
Quality of Life
Summary of Recommended Measures for Participation/ Quality of Life	DOC	N/A
Stroke Impact Scale (SIS)	NOC	N/A
Canadian Occupation Performance Measure (COPM)	NOC	N/A
Stroke Specific Quality of Life Scale (SS-QOL)	NOC	HTML
EuroQoL-5 Dimension Questionnaire	NOC	N/A
36-Item Short Form Health Survey (SF-36)	NOC	HTML
Performance Measures
Summary of Recommended Measures for Performance	DOC	N/A
Walking Speed	NOC	HTML
Pediatric
Summary of Recommended Measures for Pediatrics	DOC	N/A
Bayley Scales of Infant Development (Bayley III, BSID)	NOC	N/A
King's Outcome Scale for Childhood Head Injury (KOSCHI)	NOC	HTML
Pediatric Stroke Outcome Measure Short Neuro Exam (PSOM-SNE) - Child Version (Children Aged 2 Year and Older)	NOC	HTML
Pediatric Stroke Outcome Measure Short Neuro Exam (PSOM-SNE) - Infant Version (Infants Term Birth to Two Years)	NOC	HTML
Clinical Event End Points
Summary of Recommended Measures for Clinical Event End Points	DOC	N/A
Stroke Adjudication Worksheet	NOC	HTML
Atherosclerosis Risk in Communities Study (ARIC) TIA/Stroke Form	NOC	HTML
Questionnaire for Verifying Stroke-Free Status (QVSFS)	NOC	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 K, Oquendo MA, Gould M, Stanley B, Davies M. Am J Psychiatry. 2007 Columbia Classification Algorithm of Suicide Assessment (C-CASA): classification of suicidal events in the FDA's pediatric suicidal risk analysis of antidepressants. Jul;164(7):1035-43. PMID: 17606655).

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:

To develop the Stroke CDEs, the Stroke CDE Working Group divided into subgroups to focus on identifying and defining data elements in the domains of:

Stroke Presentation Medical History and Prior Health Status Stroke Types and Subtypes

Laboratory Tests and Vital Signs Hospital Course and Acute Therapies Long Term Therapies

Outcomes and Endpoints Imaging Biospecimens/ Biomarkers

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 presented are organized into domains which are intuitive and common in clinical research studies.

Download a “checklist” – Checklist for Stroke Clinical Trials OR Checklist for Other Stroke Clinical Studies – to help locate the CRF Modules in the Data Standards. Each checklist provides an outline of the CRF Modules that may be needed for a Stroke clinical trial/ other type of clinical study.

The Stroke CDE Working Group is currently comprised of nine different subgroups. Chairs were appointed to lead the overall Working Group and the individual subgroups. The Working Group members actively develop the CDEs for their specific subgroups and also have an opportunity to review and comment on the recommendations of the other subgroups. The Stoke CDE Working Group is supported by the NINDS CDE Team. The complete Stroke CDE Working Group roster and the rosters by Subgroup are shown below.

Complete Stroke CDE Working Group Roster

The Working Group members serve on either one or two subgroups. The subgroups began meeting by teleconference in July 2009 and continued to hold calls every four to six weeks through the spring of 2010 to define the CDEs for their domains and to recommend standardized, validated instruments for stroke research.

Working Group Chair

• Jeffrey Saver, MD - University of California, Los Angeles, Chair

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Stroke Presentation

• Lee Schwamm, MD - Harvard Medical School, Chair
• Mark Chimowitz, MD - Medical University of South Carolina
• Heather Fullerton, MD - University of California, San Francisco
• Judy Guzy, RN - University of California, Los Angeles
• David Levy, MD - Cornell Medical College
• James Meschia, MD - Mayo Clinic College of Medicine
• Lisa Michael Nassif, MD - Texas Children’s Hospital

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Medical History and Prior Health Status

• Oscar Benavente, MD - University of British Columbia, Chair
• Deborah Attix, PhD - Duke University
• Lisa Davis, RN, MSN, CCRC - National Institute of Neurological Disorders and Stroke
• Mitchell Elkind, MD - Columbia University
• Heather Fullerton, MD - University of California, San Francisco
• Mary G. George, MD, MSPH, FACS - Centers for Disease Control and Prevention
• George Howard, DrPH - University of Alabama at Birmingham
• Irene Katzan, MD - Cleveland Clinic
• Warren Lo, MD - Nationwide Children’s Hospital

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Stroke Types and Subtypes

• Joseph Broderick, MD - University of Cincinnati, Chair
• Hakan Ay, MD - Harvard Medical School
• Timothy Bernard, MD - University of Colorado Denver
• Robert Brown, MD - Mayo Clinic
• Louis Caplan, MD - Beth Israel Deaconess Medical Center
• Rebecca Ichord, MD - Children’s Hospital of Philadelphia
• J.P. Mohr, MD - Columbia University Health Sciences

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Laboratory Tests and Vital Signs

• Kyra Becker, MD - University of Washington School of Medicine, Chair
• Roderick Corriveau, PhD - Coriell Institute for Medical Research
• Judy Guzy, RN - University of California, Los Angeles
• Steven Pavlakis, MD - Maimonides Infants and Children’s Hospital
• J.J. Strouse, MD - Johns Hopkins University School of Medicine
• Mark Wainwright, MD - Northwestern University

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Hospital Course and Acute Therapies

• Karen Johnston, MD - University of Virginia, Chair
• Kyra Becker, MD - University of Washington School of Medicine
• Joseph Broderick, MD - University of Cincinnati
• Colin Derdeyn, MD - Washington University School of Medicine
• Gabrielle deVeber, MD - Hospital for Sick Children
• Mary G. George, MD, MSPH, FACS - Centers for Disease Control and Prevention
• Daniel Hanley, MD - Johns Hopkins University
• Kennedy Lees, MD - University of Glasgow
• Stephan Mayer, MD - Columbia University
• Lee Schwamm, MD - Harvard Medical School
• Mark Wainwright, MD - Northwestern University

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Long Term Therapies

• Alexander Dromerick, MD - Georgetown University School of Medicine, Chair
• Oscar Benavente, MD - University of British Columbia
• Robert Brown, MD - Mayo Clinic
• Mark Chimowitz, MD - Medical University of South Carolina
• Pamela Duncan, MD - Duke University
• Neil Friedman, MD - Cleveland Clinic
• J.P. Mohr, MD - Columbia University
• Mubeen Rafay, MB. BS - Winnipeg Children’s Hospital
• Cathy Sila, MD - Case Western Reserve University

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Outcomes and Endpoints

• Pamela Duncan, MD - Duke University, Chair
• Deborah Attix, PhD - Duke University
• Lisa Davis, RN, MSN, CCRC - National Institute of Neurological Disorders and Stroke
• William Dunn, Jr., MD - Food and Drug Administration
• Allen Heinemann, PhD - Northwestern University
• George Howard, DrPH - University of Alabama at Birmingham
• Rebecca Ichord, MD - Children’s Hospital of Philadelphia
• Kennedy Lees, MD - University of Glasgow
• Mark MacKay, MD - Royal Children’s Hospital
• Yuko Palesch, PhD - Medical University of South Carolina
• Cathy Sila, MD - Case Western Reserve University
• Michael Walker, MD - National Institute of Neurological Disorders and Stroke

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Imaging

• Chelsea Kidwell, MD - Georgetown University, Chair
• Hakan Ay, MD - Harvard Medical School
• Colin Derdeyn, MD - Washington University School of Medicine
• Edward Feldmann, MD - Brown University
• Daniel Hanley, MD - Johns Hopkins University
• Pooja Khatri, MD - University of Cincinnati
• Stephan Mayer, MD - Columbia University
• Michael Rivkin, MD - Children’s Hospital Boston
• Max Wintermark, MD - University of Virginia

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Biospecimens and Biomarkers

• James Meschia, MD - Mayo Clinic College of Medicine, Chair
• Jennifer Armstrong-Wells, MD, MPH - University of Colorado Denver
• Roderick Corriveau, PhD - Coriell Institute for Medical Research
• Bruce Coull, MD - University of Arizona College of Medicine
• Mitchell Elkind, MD - Columbia University
• Karen Furie, MD - Massachusetts General Hospital
• Edward Jauch, MD - Medical University of South Carolina
• Catherine Amlie-Lefond, MD - Medical College Wisconsin
• Alex Rai, PhD - Columbia University

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NINDS CDE Team

• Scott Janis, PhD - National Institute of Neurological Disorders and Stroke (NINDS), National Institutes of Health (NIH)
• Petra Kaufmann, MD, MSc - 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)
• Steven Warach, MD, PhD - University of Texas Southwestern Institute for Healthcare Delivery and Clinical Investigation, Austin, Texas, USA
• Sarah Duwel, RN, MA - The EMMES Corporation, Rockville, Maryland, USA (October 2012 - present)
• Pamela West - The EMMES Corporation, Rockville, Maryland, USA (October 2012 - present)
• Ethan Beaudett - KAI Research, Inc. (An Altarum Company), Rockville, Maryland, USA (2007 - September 2012)
• Stacie Grinnon, MS - KAI Research, Inc. (An Altarum Company), Rockville, Maryland, USA (2007 - September 2012)
• Lisa Hunegs, MSW, MPH - KAI Research, Inc. (An Altarum Company), Rockville, Maryland, USA (2007 - September 2012)

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Note: Institutions for all individuals acknowledged in this section were those they belonged to when they joined the Committee. All Committee 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

• Saver JL, Warach S, Janis S, Odenkirchen J, Becker K, Benavente O, Broderick J, Dromerick AW, Duncan P, Elkind MSV, Johnston K, Kidwell CS, Meschia JF, and Schwamm L, for the National Institute of Neurological Disorders and Stroke (NINDS) Stroke Common Data Element Working Group. Standardizing the Structure of Stroke Clinical and Epidemiologic Research Data: The National Institute of Neurological Disorders and Stroke (NINDS) Stroke Common Data Element (CDE) Project. Stroke. 2012 Apr;43(4):967-73. PubMed PMID: 22308239.

The Stroke CDEs were most recently revised in May 2013.The document below describes all the revisions incorporated in the May 2013 version compared to the previous version dated October 2012. Please contact NINDSCDE@emmes.com if you require further information or have any questions about the revision history.

Stroke CDEs Revision History - May 2013