Stroke

Stroke v2.0 CDEs Now Available
Important Note: The Stroke v2.0 CDEs will continue to be reviewed and revised over the next few months.

Data Standards

Organized by domains and subdomains often used in clinical studies, data standards include:

  • CDEs — Classified as Core, Supplemental–Highly Recommended, Supplemental, or Exploratory
  • CRF Modules — Template forms that logically organize CDEs for data collection
  • Guidance Documents — Provide further information about the CDEs
  • Instrument Notice of Copyright (NOC) Documents: Include pertinent information on recommended instruments

Stroke Start-Up Resource Listing: All Core and Supplemental–Highly Recommended CDEs recommended for stroke study start-up

Stroke Highlight Summary: Overview of all Stroke-specific CDE recommendations as they appear on the website

Click Expand All to view the CDEs associated with the CRF modules, organized by domain and subdomain.

 

Participant Characteristics
Demographics
CRF Module/Guidance CDEs
General Core CDE Details
Demographics CDE Details
Social Status
CRF Module/Guidance CDEs
Social Status CDE Details
Disease/Injury Related Events
Discharge Information
CRF Module/Guidance CDEs
Hospital Discharge CDE Details
Classification
CRF Module/Guidance CDEs
Stroke Types and Subtypes CDE Details
Outcomes and End Points

Overview

The National Institute of Neurological Disorders and Stroke (NINDS) formed the Stroke v1.0 CDE Working Group (WG) in July 2009. Chairs were appointed to lead the overall WG and the nine individual subgroups. The subgroups met regularly by teleconference in 2009 and 2010 to define the Common Data Elements (CDEs) for their domains and to recommend standardized, validated instruments for stroke research. The first set of CDEs for Stroke was completed in 2010.

NINDS formed an Oversight Committee (OC) to periodically review, direct the updating, and advance the development of Stroke CDEs in 2012.

In 2015, the Stroke OC reviewed the Core Stroke CDEs and determined needed classification updates based on disease stage and study type.

Based on the Stroke OC’s input, a Stroke v2.0 CDE Working Group was convened in 2018 to perform a comprehensive review of the Stroke CDEs. The WG was also asked to review the Unruptured Cerebral Aneurysms and Subarachnoid Hemorrhage (SAH) CDEs for inclusion and harmonization. The Stroke v2.0 CDE WG was divided into eight domain-specific subgroups:

  • Stroke Presentation and Vital Signs
  • Medical History and Prior Health Status
  • Stroke Types and Subtypes
  • Hospital Course and Acute Therapies
  • Long Term Therapies
  • Outcomes and Endpoints
  • Imaging
  • Biospecimens, Biomarkers, and Laboratory Tests

The Stroke v2.0 CDEs were posted in summer 2020.

The Stroke CDE Working Group and Oversight Committee are supported by the NINDS CDE Team.

Download a “checklist” to help locate the CRF modules that are part of 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.

Checklist for Stroke Clinical Trials
Checklist for Other Stroke Clinical Studies

Roster

Complete Version 1.0 Stroke CDE Working Group Roster – Lists members of the Stroke v1.0 CDE Working Group by subgroup, previous members of the Oversight Committee, and the NINDS CDE Team.

Members of the Stroke v2.0 CDE Working Group by subgroup, current members of the Oversight Committee, and the NINDS CDE Team are listed below.

Please see the Overview tab for additional project background and timeline information.

Oversight Committee Members

  • Jeffrey Saver, MD
    University of California Los Angeles, Los Angeles, California
    Co-Chair
  • Steven Warach, MD, PhD
    The University of Texas at Austin, Austin, Texas
    Co-Chair
  • Catherine Amlie-Lefond, MD
    Seattle Children's Hospital, Seattle Washington
  • Joseph Broderick, MD
    University of Cincinnati, Cincinnati, Ohio
  • Colin Derdeyn, MD
    Carver College of Medicine, University of Iowa, Iowa City, Iowa
  • William Dunn, Jr., MD
    Food and Drug Administration (FDA), Silver Spring, Maryland
  • Mitchell Elkind, MD
    Columbia University, New York, New York
  • Lawrence Fine, MD
    National Heart Lung and Blood Institute (NHLBI), National Institutes of Health (NIH), Bethesda, Maryland
  • Mary G. George, MD, MSPH, FACS
    Centers for Disease Control and Prevention (CDC), Atlanta, Georgia
  • Virginia Howard, PhD
    University of Alabama at Birmingham, Birmingham, Alabama
  • Pooja Khatri, MD
    University of Cincinnati, Cincinnati, Ohio
  • Lee Schwamm, MD
    Massachusetts General Hospital, Harvard Medical School, Cambridge, Massachusetts
  • Jose Ignacio Suarez, MD
    Johns Hopkins University School of Medicine, Baltimore, Maryland

Working Group Chairs

  • Jeffrey Saver, MD
    University of California Los Angeles, Los Angeles, California
    Co-Chair
  • Steven Warach, MD, PhD
    The University of Texas at Austin, Austin, Texas
    Co-Chair

Stroke Presentation and Vital Signs Version 2.0

  • Pooja Khatri, MD
    University of Cincinnati, Cincinnati, Ohio
    Chair
  • Yu-Feng Yvonne Chan, MD, PhD
    Icahn School of Medicine at Mount Sinai, New York, New York
  • Heather Fullerton, MD
    University of California San Francisco, San Francisco, California
  • James Meschia, MD
    Mayo Clinic College of Medicine, Jacksonville, Florida
  • Steven Pavlakis, MD
    SUNY Downstate School of Medicine, Brooklyn, New York
  • Lee Schwamm, MD
    Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts
  • Olajide Williams, MD
    Columbia University Medical Center, New York, New York

Medical History and Prior Health Status Version 2.0

  • Mitchell Elkind, MD
    Columbia University, New York, New York
    Chair
  • Mary G. George, MD, MSPH, FACS
    Centers for Disease Control and Prevention (CDC), Atlanta, Georgia
  • George Howard, DrPH
    University of Alabama at Birmingham, Birmingham, Alabama
  • Irene Katzan, MD
    Cleveland Clinic, Cleveland, Ohio
  • Warren Lo, MD
    Nationwide Children's Hospital, Columbus, Ohio

Stroke Types and Subtypes Version 2.0

  • Joseph Broderick, MD
    University of Cincinnati, Cincinnati, Ohio
    Chair
  • Hakan Ay, MD
    Harvard Medical School, Boston, Massachusetts
  • Timothy Bernard, MD
    University of Colorado Denver, Denver, Colorado
  • Christine Fox, MD
    University of California, San Francisco, San Francisco, California

Hospital Course and Acute Therapies Version 2.0

  • Magdy Selim, MD, PhD
    Harvard Medical School, Boston, Massachusetts
    Chair
  • Opeolu Adeoye, MD, MS
    University of Cincinnati, Cincinnati, Ohio
  • Gabrielle deVeber, MD
    Hospital for Sick Children, Toronto, Canada

Long Term Therapies Version 2.0

  • Alexander Dromerick, MD
    Georgetown University School of Medicine, Washington, District of Columbia
    Chair
  • Robynne Braun, MD, PhD
    University of Maryland School of Medicine, Baltimore, Maryland
  • Robert Brown, MD, MPH
    Mayo Clinic, Rochester, Minnesota
  • Wuwei (Wayne) Feng, MD, MS
    Duke University School of Medicine, Durham, North Carolina
  • Mubeen F. Rafay, MB.BS, MSc.
    Winnipeg Children's Hospital, University of Manitoba, Manitoba, Canada
  • Preeti Raghavan, MD
    Johns Hopkins University School of Medicine, Baltimore, Maryland
  • Jose Ignacio Suarez, MD
    Johns Hopkins University School of Medicine, Baltimore, Maryland

Outcomes and Endpoints Version 2.0

  • Pamela Duncan, PhD
    Wake Forest School of Medicine, Winston-Salem, North Carolina
    Chair
  • Julius Fridriksson, PhD
    University of South Carolina, Columbia, South Carolina
  • Allen W. Heinemann, PhD, ABPP (RP), FACRM
    Northwestern University, Shirley Ryan AbilityLab, Chicago, Illinois
  • Rebecca Ichord, MD
    Children's Hospital of Philadelphia, Philadelphia, Pennsylvania
  • Stephanie Kemp, CRC
    Stanford University, Stanford, California
  • Brett Kissela, MD, MS
    University of Cincinnati, Cincinnati, Ohio
  • Ronald Lazar, PhD
    University of Alabama at Birmingham, Birmingham, Alabama
  • Trudy Mallinson, PhD
    The George Washington University, Washington, District of Columbia
  • Yuko Palesch, PhD
    Medical University of South Carolina, Charleston, South Carolina

Imaging Version 2.0

  • David Liebeskind, MD
    University of California Los Angeles, Los Angeles, California
    Chair
  • Colin Derdeyn, MD
    University of Iowa, Iowa City, Iowa
  • Edward Feldmann, MD
    University of Massachusetts Medical School, Worcester, Massachusetts
  • Maarten Lansberg, MD
    Stanford University, Stanford, California
  • Stephan Mayer, MD
    Henry Ford Health System, Detroit, Michigan
  • Michael Rivkin, MD
    Boston Children's Hospital, Boston, Massachusetts
  • Max Wintermark, MD
    Stanford University, Stanford, California

Biospecimens, Biomarkers, and Laboratory Tests Version 2.0

  • Sean Savitz, MD
    The University of Texas McGovern Medical School, Houston, Texas
    Chair
  • Catherine Amlie-Lefond, MD
    Seattle Children's Hospital, Seattle Washington
  • Jennifer Beauchamp, PhD, RN
    Cizik School of Nursing at UTHealth, Houston, Texas
  • Huimahn Alex Choi, MD, MS
    The University of Texas McGovern Medical School, Houston, Texas
  • Bruce Coull, MD
    University of Arizona College of Medicine, Tucson, Arizona
  • Anthony Kim, MD
    University of California, San Francisco, San Francisco, California
  • John J. Strouse, MD
    Duke University, Durham, North Carolina
  • Mark Wainwright, MD
    University of Washington, Seattle, Washington
  • Dileep R. Yavagal, MD, FAHA, FAAN, FSVIN
    University of Miami Miller School of Medicine, Miami, Florida

NINDS CDE Team

  • Scott Janis, PhD
    National Institute of Neurological Disorders and Stroke (NINDS), National Institutes of Health (NIH), Bethesda, Maryland
  • M. Carolina Mendoza-Puccini, MD
    NINDS CDE Project Officer, National Institute of Neurological Disorders and Stroke (NINDS), National Institutes of Health (NIH), Bethesda, Maryland
  • Clinton Wright, MD, MSc
    Director, Office of Clinical Research, Associate Director, National Institute of Neurological Disorders and Stroke (NINDS), National Institutes of Health (NIH), Bethesda, Maryland
  • Sherita Ala'i Hansen, MS
    The Emmes Company, LLC
  • Damon Collie, MSHS
    The Emmes Company, LLC
  • Joy Esterlitz, MS
    The Emmes Company, LLC
  • Katelyn Gay, BS
    The Emmes Company, LLC
  • Marybeth Montoro, MPH, CPH
    The Emmes Company, LLC
  • Muniza Sheikh, MS, MBA
    The Emmes Company, LLC
  • Pamela West
    The Emmes Company, LLC

Publications

Publications

Updates

Please see attached revision history document. Please contact NINDSCDE@emmes.com if you require further information or have any questions about the revision history.

Stroke CDEs Revision History