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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Select a Sub-Disease for your NeuroRehab study to view the CDEs for those types of studies.

NeuroRehab Comprehensive includes all CDE recommendations.

NeuroRehab General includes all CDE recommendations that are not disease specific.

All other Sub-Diseases include recommendations specific to existing NINDS CDE project disorders.

NIH Resources
NIH Resources
CRF Module/Guidance CDEs
National Institutes of Health (NIH) Toolbox N/A
Patient-Reported Outcomes Measurement Information System (PROMIS) N/A
Quality of Life in Neurological Disorders (Neuro-QOL) N/A
Participant Characteristics
Demographics
CRF Module/Guidance CDEs
General Core CDE Details
Demographics CDE Details
Social Status
CRF Module/Guidance CDEs
Social Status CDE Details
Participant History and Family History
General Health History
CRF Module/Guidance CDEs
Behavioral History CDE Details
Family History - Affected Relatives and Pedigree CDE Details
Godin Leisure-Time Exercise Questionnaire CDE Details
History Data Source and Reliability CDE Details
Medical History CDE Details
Pediatric Developmental History CDE Details
Reproductive and Hormonal History 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
Assessments and Examinations
Laboratory Tests and Biospecimens/Biomarkers
CRF Module/Guidance CDEs
Biospecimens Summary Statement N/A
Laboratory Test Recommendations N/A
Genetics CDE Details
Physical/Neurological Examination
CRF Module/Guidance CDEs
Grip Strength Fatigue CDE Details
Physical Exam CDE Details
Imaging Diagnostics
CRF Module/Guidance CDEs
Imaging Analysis Results - Follow Up CDE Details
Imaging Analysis Technique and Results - Baseline CDE Details
Imaging OCT Analysis - Contrast and Visual Acuity CDE Details
Imaging OCT Analysis - RNFL Thickness Analysis CDE Details
Imaging OCT Analysis - Spectralis Report Analysis CDE Details
Imaging OCT Analysis - Stratus Retinal Thickness Report CDE Details
Imaging OCT Analysis -Cirrus Macular Thickness CDE Details
Imaging Optical Coherence Tomography (OCT) Information CDE Details
Magnetic Resonance Imaging (MRI) CDE Details
Non-Imaging Diagnostics
CRF Module/Guidance CDEs
Non-Imaging Diagnostics Recommendations N/A
Vital Signs and Other Body Measures
CRF Module/Guidance CDEs
Vital Signs CDE Details
Outcomes and End Points
Quality of Life/Patient Reported Outcomes
CRF Module/Guidance CDEs
Multiple Sclerosis Spasticity Scale (MSSS-88) N/A
Clinical Global Impression Scale N/A
EuroQoL-5 Dimension Questionnaire (EQ-5D) N/A
EuroQoL-VAS N/A
ICIQ-Lower Urinary Tract Symptoms Quality of Life N/A
MOS Modified Social Support Survey (MSSS) Component of the Multiple Sclerosis Quality of Life Inventory (MSQLI) N/A
Multiple Sclerosis International Quality of Life Questionnaire (MusiQoL) N/A
Multiple Sclerosis Quality of Life Inventory (MSQLI) N/A
Multiple Sclerosis Quality of Life-54 Instrument (MSQOL-54) N/A
Patient Reported Impact of Multiple Sclerosis (PRIMuS) N/A
Sexual Satisfaction Scale (SSS) N/A
Treatment Satisfaction Questionnaire for Medication N/A
Performance Measures
CRF Module/Guidance CDEs
Timed 25-Foot Walk (T25-FW) CDE Details
10 Meter Timed Walk N/A
6 Minute Walk Test N/A
Grooved Pegboard Test N/A
Hauser Ambulation Index (AI) N/A
Modified Ashworth Scale for Grading Spasticity N/A
Multiple Sclerosis Walking Scale (MSWS) N/A
National Eye Institute 25 Item Visual Functioning Questionnaire (NEI-VFQ-25) CDE Details
Nine Hole Peg Test N/A
Pelli Robson Test N/A
Scale for the Assessment and Rating of Ataxia (SARA) N/A
Sloan Low Contrast Letter Acuity N/A
Timed Up and Go (TUG) N/A
Neuropsychological Testing
CRF Module/Guidance CDEs
Neuropsychology/Cognition Recommendations - Adult and Pediatric N/A
Automated Neuropsychological Assessment Metrics (ANAM) N/A
Beery-Buktenica Developmental Test of Visual-Motor Integration (Beery VMI) N/A
Brief Visuospatial Memory Test Revised (BVMT-R) N/A
California Verbal Learning Test - Children (CVLT-C) N/A
California Verbal Learning Test - Second Edition (CVLT-II) N/A
Center for Epidemiologic Studies-Depression Scale (CES-D) CDE Details
Clinical Evaluation of Language Fundamentals - Fifth Edition (CELF-5) N/A
Conner's Continuous Performance Test III N/A
Contingency Naming Test (CNT) N/A
Controlled Oral Word Association Test (COWAT) subtest of the Multilingual Aphasia Examination (MAE) N/A
Delis-Kaplan Executive Function System (D-KEFS) N/A
Expanded Disability Status Scale (EDSS) N/A
Expressive One-Word Picture Vocabulary Test N/A
Nonverbal Selective Reminding Test (NVSRT) N/A
Rey Auditory Verbal Learning Test (RAVLT) N/A
Stroop Test CDE Details
Symbol Digit Modalities Test N/A
Test of Memory and Learning Revised (TOMAL-2) N/A
Wechsler Abbreviated Scale of Intelligence (WASI) N/A
Wechsler Intelligence Scale for Children-V (WISC-V) N/A
Wide Range Assessment of Memory and Learning, Second Edition (WRAML-2) N/A
Wisconsin Card Sorting Test (WCST) N/A
Woodcock-Johnson III Test of Cognitive Abilities N/A
Activities of Daily Living/Performance
CRF Module/Guidance CDEs
Activities Specific Balance Confidence Scale (ABC-Scale) N/A
Barthel Index N/A
Berg Balance Scale (BBS) CDE Details
Bladder Control Scale (BLCS) CDE Details
Bowel Control Scale (BWCS) CDE Details
Brief Pain Inventory (BPI) Short Form N/A
Disease Steps (DS) CDE Details
Fatigue Scale for Motor and Cognitive Functions N/A
Fatigue Severity Scale (FSS) N/A
Fatigue/Activity Record and Diary CDE Details
Functional Assessment of Multiple Sclerosis (FAMS) N/A
Functional Independence Measure (FIM) N/A
Impact of Visual Impairment Scale N/A
McGill Pain Questionnaire (MPQ) N/A
Modified Fatigue Impact Scale (MFIS) CDE Details
MOS Pain Effects Scale (PES) Component of Multiple Sclerosis Quality of Life Inventory (MSQLI) N/A
Multiple Sclerosis Functional Composite Timed 25 Foot Walk Nine Hole Peg Test Paced Auditory Serial Addition Test N/A
Multiple Sclerosis Impact Scale (MSIS-29) N/A
Patient Determined Disease Steps N/A
PROMIS Fatigue Short Form N/A
PROMIS Pain Interference Short Form N/A
Short Form 12- Item Health Survey (SF-12) N/A
Short Form 36-Item Health Survey (SF-36) N/A
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

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 https://cssrs.columbia.edu/).

Instrument Notice of Copyright Information

The NINDS CDE Team does not post proprietary instruments/scales recommended by the CDE Working Groups on this website. This includes, but is not limited to, copyrighted or trademarked instruments/scales. Information about recommended instruments can be found in the Notice of Copyright (NOC) documents under ‘CRF Module/Guidance’ on each disorder’s data standards page. For any questions regarding these instruments/scales please contact the corresponding owner/author. The NINDS CDE Team is not responsible for the availability or content of these external sites, nor does the NINDS CDE Team endorse, warrant or guarantee the products, services or information described or offered at these other internet sites.

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