Multiple Sclerosis

Data Standards

The National Institute of Neurological Disorders and Stroke (NINDS) and other Federal agencies and international organizations have the common mission of developing data standards for clinical research. Through the efforts of subject-specific working groups, topic-driven data elements have been created. The first set of Common Data Elements (CDEs) for Multiple Sclerosis was developed in 2011. The Core data elements to be used by an investigator when beginning a research study in this disease/disorder are listed in the Start-up Resource Listing.

Many of the CDEs will overlap across study types, which allows for comparisons and meta-analysis across studies. Consistency of the data elements and the CDE formats is kept in order to ensure the ability to transfer critical medical information electronically from one center to another. This consistency also allows for continuity across different disease areas. The goals of the NINDS CDE initiative are to increase the efficiency and effectiveness of clinical research studies and clinical treatment, increase data quality, facilitate data sharing, and help educate new clinical investigators.

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

An overview of all Multiple Sclerosis (MS) CDE recommendations can be found in the Multiple Sclerosis (MS) CDE Highlight Summarydocument. For your reference, a zip file containing all the current Multiple Sclerosis (MS) CDE template CRF modules can be downloaded below.

The outline that follows includes all the CDEs associated with the CRF modules, organized by domain and sub-domain.

Participant Characteristics
Demographics
CRF Module/Guideline CDEs
General Core CDE Details
Demographics CDE Details
Social Status
CRF Module/Guideline CDEs
Social Status CDE Details
Disease/Injury Related Events
Classification
CRF Module/Guideline CDEs
Diagnosis and Disease Characteristics CDE Details
History of Disease/Injury Event
CRF Module/Guideline CDEs
Multiple Sclerosis Severity Score (MSSS) N/A
Relapse CDE Details
Outcomes and End Points
Summary of All Outcome Recommendations
CRF Module/Guideline CDEs
Clinical Outcomes Summary Statement N/A
MS CDE Instrument Recommendations by Outcome Domain and Classification N/A

Overview

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

History and Acknowledgements

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

  • 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

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

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

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

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)

  • 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)

  • 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

  • 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

  • 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

  • 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

  • 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
    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
    The Emmes Corporation
  • Ilar Edun, BA
    The Emmes Corporation
  • Joy Esterlitz, MS
    The Emmes Corporation
  • Robin Feldman, BS, MBA
    The Emmes Corporation
  • Katelyn Gay, BS
    The Emmes Corporation
  • 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

References

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