Multiple Sclerosis

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 (Instrument Notice of Copyright Information)

Multiple Sclerosis Start-up Resource Listing: All Core and Supplemental–Highly Recommended CDEs recommended for Multiple Sclerosis study start-up

Multiple Sclerosis Highlight Summary: Overview of all Multiple Sclerosis-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.

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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
History of Disease/Injury Event
CRF Module/Guidance CDEs
Fatigue Visual Analog Scale CDE Details
Multiple Sclerosis Severity Score (MSSS) N/A
Relapse CDE Details
Classification
CRF Module/Guidance CDEs
Diagnosis and Disease Characteristics CDE Details
Outcomes and End Points
Summary of All Outcome Recommendations
CRF Module/Guidance CDEs
Clinical Outcomes Summary Statement N/A
MS CDE Instrument Recommendations by Outcome Domain and Classification N/A

Overview

The first set of Common Data Elements (CDEs) for Multiple Sclerosis was developed in 2011.

To develop the Multiple Sclerosis (MS) CDEs, the MS CDE Working Group divided into subgroups to focus on identifying and defining data elements in the domains of:

  • Biospecimens
  • Demographics and Clinical Assessments
  • Imaging
  • Neuropsychology/Cognition
  • Operations/Special Advisors

Roster

The National Institute of Neurological Disorders and Stroke (NINDS) has formed an Oversight Committee to direct the updating and further development of Multiple Sclerosis CDEs. The Multiple Sclerosis CDE Committee is supported by the NINDS CDE Team.

Previously, the Multiple Sclerosis CDE Committee was currently comprised of five different subgroups. Chairs were appointed to lead the overall Working Group and the individual subgroups. The Working Group members actively developed the CDEs for their specific subgroups and also had an opportunity to review and comment on the recommendations of the other subgroups.

The subgroups began meeting by teleconference in February 2011 and continued to hold calls every four to six weeks through the fall of 2011 to define the CDEs for their domains and to recommend standardized, validated instruments for MS research. The Multiple Sclerosis CDE Oversight Committee was created in 2013.

Complete Multiple Sclerosis CDE Roster

Oversight Committee Members

Oversight Committee Members

  • Fred Lublin, MD
    Mount Sinai Medical Center, New York, New York
    Chair
  • Douglas Arnold, MD
    McGill University, Montreal, Canada
  • Ralph Benedict, PhD
    University at Buffalo, Buffalo, New York
  • Peter S. Chin, MD, MSHS
    Genentech-Roche, San Francisco, California
  • Gary Cutter, PhD
    The University of Alabama at Birmingham School of Public Health, Birmingham, Alabama
  • Robert J. Fox, MD, FAAN
    Neurological Institute, Cleveland Clinic, Cleveland, Ohio
  • Gordon Francis, MD
    Novartis Pharmaceuticals, San Francisco, California
  • Mark Freedman, MD, CSPQ, FAAN, FRCP(C)
    Ottawa Hospital Research Institute, Ottawa, Canada
  • Deborah Hertz, MPH
    National Multiple Sclerosis Society, New York, New York (until 2018)
  • Mary Hughes, MD
    Augusta MS Center, Augusta, Georgia
  • Nicholas LaRocca, PhD
    National Multiple Sclerosis Society, New York, New York
  • Ruth Ann Marrie, MD, PhD, FRCP(C)
    University of Manitoba, Winnipeg, Canada
  • Penny Pennington, MAS
    Advancing Research in MS, Buffalo, New York
  • Richard Rudick, MD
    Cleveland Clinic Lerner College of Medicine, Cleveland, Ohio (until 2018)

Working Group Co-Chairs

Working Group Co-Chairs

  • Fred Lublin, MD
    Mount Sinai Medical Center, New York, New York
  • Chris Polman, MD, PhD
    VU University Medical Center Amterdam, Amsterdam, The Netherlands

Biospecimens

Biospecimens

  • Gordon Francis, MD
    Novartis Pharmaceuticals, San Francisco, California
  • Philip de Jager, MD, PhD
    Brigham and Women's Hospital, Boston, Massachusetts
  • Suhayl Dhib-Jalbut, MD
    Robert Wood Johnson Medical School, New Brunswick, New Jersey
  • Steven Jacobson, PhD
    National Institute of Neurological Disorders and Stroke (NINDS), National Institutes of Health (NIH), Bethesda, Maryland
  • Jens Kuhle, MD
    University Hospital of Basel, Basel, Switzerland
  • Jorge Oksenberg, PhD
    University of California San Francisco, San Francisco, California
  • Michael Racke, MD
    The Ohio State University Medical Center, Columbus, Ohio

Demographics and Clinical Assessments

Demographics and Clinical Assessments

  • Howard Weiner, MD
    Brigham and Women's Hospital, Boston, Massachusetts
    Chair

Demographics and Clinical Assessments (Demographics and Medical History)

Demographics and Clinical Assessments (Demographics and Medical History)

  • Richard Rudick, MD
    Cleveland Clinic Lerner College of Medicine, Cleveland, Ohio
    Vice Chair
  • Brenda Banwell, MD
    The Hospital for Sick Children, University of Toronto, Toronto, Canada
  • Tanuja Chitnis, MD
    Brigham and Women's Hospital, Boston, Massachusetts
  • Christian Confavreux, MD
    H?pital Neurologique Pierre Wertheimer, Bron, France
  • Yossi Gilgun-Sherki, PhD
    Teva Pharmaceuticals Industries Ltd, Petah Tikva, Israel
  • Deborah Hertz, MPH
    National Multiple Sclerosis Society, New York, New York
  • Annette Langer-Gould, MD
    Kaiser Permanente Department of Research & Evaluation, Pasadena, California
  • Ruth Ann Marrie, MD, PhD, FRCP(C)
    University of Manitoba, Winnipeg, Canada
  • Luanne Metz, MD, FRCP
    University of Calgary, Calgary, Canada
  • Daniel Mikol, MD, PhD
    Amgen, Thousand Oaks, California
  • William Pryse-Phillips, MD
    Memorial University of Newfoundland, St. John's, Canada
  • Dessa Sadovnick, PhD
    University of British Columbia, Vancouver, Canada
  • Leslie Weiner, MD
    Keck School of Medicine of University of Southern California, Los Angeles, California

Demographics and Clinical Assessments (Laboratory Tests and Non-Imaging Diagnostics)

Demographics and Clinical Assessments (Laboratory Tests and Non-Imaging Diagnostics)

  • Bibiana Bielekova, MD
    National Institute of Neurological Disorders and Stroke (NINDS), National Institutes of Health (NIH), Bethesda, Maryland
    Vice Chair
  • Jack Antel, MD
    McGill University, Montreal, Canada
  • Patricia Coyle, MD
    State University of New York at Stony Brook, Stony Brook, New York
  • Anne Cross, MD
    Washington University School of Medicine, St. Louis, Missouri
  • Mark Freedman, MD, CSPQ, FAAN, FRCP(C)
    Ottawa Hospital Research Institute, Ottawa, Canada
  • Robert Lisak, MD, FAAN, FRCP
    Wayne State University School of Medicine, Detroit, Michigan
  • John Richert, MD
    Business Partner-MD, Henderson, Nevada

Demographics and Clinical Assessments (Outcomes and Neurological/Physical Exam)

Demographics and Clinical Assessments (Outcomes and Neurological/Physical Exam)

  • Stephen Hauser, MD
    University of California San Francisco, San Francisco, California
    Vice Chair
  • Peter S. Chin, MD, MSHS
    Genentech-Roche, San Francisco, California
  • Michel Clanet, MD
    Hospital Center University Toulouse, Toulouse, France
  • Jeffrey Cohen, MD
    Cleveland Clinic Lerner College of Medicine, Cleveland, Ohio
  • Jenny Freeman, PhD
    University of Plymouth, Plymouth, United Kingdom
  • Ludwig Kappos, MD
    University Hospital of Basel, Basel, Switzerland
  • Aaron Miller, MD
    Mount Sinai School of Medicine, New York, New York
  • Xavier Montalban, MD
    Hospital Universitari Vall D'Hebron, Barcelona, Spain
  • Paul O'Connor, MD
    University of Toronto, Toronto, Canada
  • Stephen Reingold, PhD
    Scientific and Clinical Review Associates LLC, Salisbury, Connecticut
  • Per Soelberg Sorensen, MD, DMsc, FAAN
    Copenhagen University Hospital, Kobenhavn, Denmark
  • Emmanuelle Waubant, MD, PhD
    University of California San Francisco, San Francisco, California

Imaging

Imaging

  • Jerry Wolinsky, MD
    University of Texas Health Science Center at Houston, Houston, Texas
    Chair
  • Douglas Arnold, MD
    McGill University, Montreal, Canada
  • Laura Balcer, MD, MSCE
    Hospital of the University of Pennsylvania, Philadelphia, Pennsylvania
  • Frederik Barkhof, MD
    VU Medical Center Amsterdam, Amsterdam, The Netherlands
  • Massimo Filippi, MD
    University Ospedale San Raffaele, Milano, Italy
  • Elizabeth Fisher, PhD
    Cleveland Clinic Lerner Research Institute, Cleveland, Ohio
  • Volker Knappertz, MD
    Teva Pharmaceuticals Industries Ltd, Philadelphia, Pennsylvania
  • David Miller, MD
    UCL Institute of Neurology, London, United Kingdom
  • Jack Simon, MD
    Oregon Health and Sciences University, Portland, Oregon

Neuropsychology/Cognition

Neuropsychology/Cognition

  • Ralph Benedict, PhD
    University at Buffalo, Buffalo, New York
    Chair
  • Maria Pia Amato, MD
    University of Florence, Florence, Italy
  • Gordon Francis, MD
    Novartis Pharmaceuticals, San Francisco, California
  • Laura Julian, PhD
    University of California San Francisco, San Francisco, California
  • Lauren Krupp, MD
    Stony Brook University Hospital, Stony Brook, New York
  • Dawn Langdon, PhD
    Royal Holloway, University of London, Egham, United Kingdom
  • Nicholas LaRocca, PhD
    National Multiple Sclerosis Society, New York, New York
  • Stephen Rao, PhD
    Cleveland Clinic Lerner College of Medicine, Cleveland, Ohio
  • Christine Till, PhD, Cpsych
    York University, Toronto, Canada

Operations/Special Advisors

Operations/Special Advisors

  • Timothy Coetzee, PhD
    National Multiple Sclerosis Society, New York, New York
  • Gary Cutter, PhD
    The University of Alabama at Birmingham School of Public Health, Birmingham, Alabama
  • George Ebers, MD
    University of Oxford, Oxford, United Kingdom
  • Maria Pia Sormani, PhD
    University of Genoa, Genova, Italy

NINDS CDE Team

NINDS CDE Team

  • Robin Conwit, MD
    National Institute of Neurological Disorders and Stroke (NINDS), National Institutes of Health (NIH), Bethesda, Maryland
  • Codrin Lungu, MD
    National Institute of Neurological Disorders and Stroke (NINDS), National Institutes of Health (NIH), Bethesda, Maryland
  • M. Carolina Mendoza-Puccini, MD
    NINDS CDE Program Director, National Institute of Neurological Disorders and Stroke (NINDS), National Institutes of Health (NIH), Bethesda, Maryland
  • Claudia S. Moy, PhD
    National Institute of Neurological Disorders and Stroke (NINDS), National Institutes of Health (NIH), Bethesda, Maryland
  • Joanne Odenkirchen, MPH
    NINDS CDE Project Officer, National Institute of Neurological Disorders and Stroke (NINDS), National Institutes of Health (NIH), Bethesda, Maryland
  • Ursula Utz, PhD, MBA
    National Institute of Neurological Disorders and Stroke (NINDS), National Institutes of Health (NIH), Bethesda, Maryland
  • Sherita Ala'i Hansen, MS (Until 2018)
    The Emmes Company, LLC, Rockville, Maryland
  • Ilar Edun, BA (Until 2020)
    The Emmes Company, LLC, Rockville, Maryland
  • Joy Esterlitz, MS (Until 2020)
    The Emmes Company, LLC, Rockville, Maryland
  • Robin Feldman, BS, MBA
    The Emmes Company, LLC, Rockville, Maryland
  • Katelyn Gay, BS
    The Emmes Company, LLC, Rockville, Maryland
  • Stacie Grinnon, MS
    KAI Research, Inc. (An Altarum Company), Rockville, Maryland
  • Megan Schmidt
    KAI Research, Inc. (An Altarum Company), Rockville, Maryland
  • Alexandra Stout
    KAI Research, Inc. (An Altarum Company), Rockville, Maryland

Publications

A publication related to the MS CDE initiative will be written at a later date. The citation for this publication will be included on this site as soon as it is available.

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.

Multiple Sclerosis CDEs Revision History