Myasthenia Gravis

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 Myasthenia Gravis 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 Myasthenia Gravis CDE recommendations can be found in the Myasthenia Gravis CDE Highlight Summary document. For your reference, a zip file containing all of the Myasthenia Gravis CDE CRF modules, instrument recommendations, and guideline documents can be downloaded below.

Participant Characteristics
CRF Module/Guidance CDEs
General Core CDE Details
Demographics - MG CDE Details
Social Status
CRF Module/Guidance CDEs
Social Status - MG CDE Details
Participant History and Family History
Disease/Injury Related Events
CRF Module/Guidance CDEs
Confirmatory Diagnostic Tests - MG CDE Details
History of Disease/Injury Event
CRF Module/Guidance CDEs
Medical History of MG - MG CDE Details
Treatment/Intervention Data
CRF Module/Guidance CDEs
Prior and Current Treatments for MG - MG CDE Details
Surgeries and Other Procedures
CRF Module/Guidance CDEs
Thymectomy - MG CDE Details
Outcomes and End Points
Emotional and Cognitive Status
CRF Module/Guidance CDEs
Cognitive Guidelines for Use N/A
End Points
CRF Module/Guidance CDEs
Death Report CDE Details
Summary of All Outcome Recommendations
CRF Module/Guidance CDEs
MG Clinical Outcomes Recommendations by Domain and Classification - MG N/A
Functional Outcomes
CRF Module/Guidance CDEs
Modified Rankin Scale (mRS) CDE Details


In order to create a comprehensive set of CDEs for Neuromuscular Diseases, the NINDS formed the following unique Working Groups: Neuromuscular Diseases (NMD), Myasthenia Gravis (MG), Spinal Muscular Atrophy (SMA), and Duchenne/Becker Muscular Dystrophy (DMD/BMD).

The NMD CDE Working Group’s goal was to identify elements that would be useful across multiple types of NMD Clinical Studies. In order to achieve this objective, the NMD Working Group was divided into two focus areas – Adult studies and Pediatric studies. In both the Adult and Pediatric areas, subgroups were formed to focus on defining data elements in the domains of:

  • Biomarkers/Genetics/Imaging
  • Cardiac/Pulmonary
  • Clinical Outcomes
  • Cognitive/Behavioral/Psychological Assessments
  • Demographics


While the Adult and Pediatric Working Groups initially worked separately, their age-specific NMD recommendations were later combined to form Version 1.0 of the NMD CDEs.

Additionally, the NINDS formed Working Groups to develop recommendations specific for Spinal Muscular Atrophy (SMA), Myasthenia Gravis (MG), and Duchenne and Becker Muscular Dystrophy (DMD/BMD). These three Working Groups were responsible for reviewing the NMD CDEs and forming disease-specific recommendations to supplement the overarching Neuromuscular Diseases CDEs.

Another Working Group was form prior to the Neuromuscular Diseases CDE Working Group and was focused on developing Congenital Muscular Dystrophy (CMD) CDEs for a natural history study. These CDEs are not incorporated with the NMD Diseases CDEs but are available as a zip file on the NMD data standards page.


The National Institute of Neurological Disorders and Stroke (NINDS) has formed an Oversight Committee to direct the updating and further development of Neuromuscular Diseases CDEs.

The Neuromuscular Diseases CDE Committee was formed first and focused on a set of general CDE recommendations to be utilized in clinical research across all neuromuscular diseases. Additional CDE Working Groups were subsequently formed to develop disease-specific recommendations for:

All three Working Groups (MG, SMA, and DMD/BMD) were charged with reviewing the combined Adult and Pediatric NMD CDEs to determine the additional elements needed for an MG, SMA, or DMD/BMD specific study.

All Working Group members actively developed the CDEs for their specific disease areas/subgroups and had an opportunity to review and comment on the draft recommendations internally prior to public review and posting. The NMD, MG, SMA, and DMD/BMD CDE Working Groups are supported by the NINDS CDE Team. The complete rosters for each Working Group and the rosters by NMD Subgroup are shown below. The Neuromuscular Diseases CDE Oversight Committee was created in 2013.

Complete Adult NMD Working Group Roster

Complete Pediatric NMD Working Group Roster

Complete Myasthenia Gravis (MG) Working Group Roster

Complete Spinal Muscular Atrophy (SMA) Working Group Roster

Complete Duchenne and Becker Muscular Dystrophy Working Group Roster

Complete NMD Oversight Committee Roster


Myasthenia Gravis (MG) Working Group

  • Don Sanders, MD
    Duke University, Durham, North Carolina
  • Gil Wolfe, MD
    Jacobs Neurological Institute, Buffalo, New York
  • Fulvio Baggi, MD
    Carlo Besta Institute, Milan, Italy
  • Ted Burns, MD
    University of Virginia, Charlottesville, Virginia
  • Henry Kaminski, MD
    George Washington University, Washington, District of Colombia
  • Matt Meriggioli, MD
    University of Illinois College of Medicine at Chicago, Chicago, Illinois


  • Robin Conwit, MD
    National Institute of Neurological Disorders and Stroke (NINDS), National Institutes of Health (NIH), Bethesda, Maryland
  • Elizabeth McNeil, MD, MSc
    National Institute of Neurological Disorders and Stroke (NINDS), National Institutes of Health (NIH), Bethesda, Maryland
  • Glen Nuckolls, PhD
    National Institute of Neurological Disorders and Stroke (NINDS), National Institutes of Health (NIH), Bethesda, Maryland
  • Joanne Odenkirchen, MPH (Until 2016)
    NINDS CDE Project Officer, National Institute of Neurological Disorders and Stroke (NINDS), National Institutes of Health (NIH), Bethesda, Maryland
  • Sherita Ala'i, MS (Until 2018)
    The Emmes Corporation
  • Lisa Hunegs, MSW, MPH (until 2012)
    KAI Research, Inc. (An Altarum Company), Rockville, Maryland
  • Kristy Miller, MPH (Until 2012)
    KAI Research, Inc. (An Altarum Company), Rockville, Maryland
  • Christina You, MSPH (Until 2012)
    KAI Research, Inc. (An Altarum Company), Rockville, Maryland


A publication related to the NMD CDE initiative is in development. The citation for this publication will be included on this site as soon as it is available.


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

Myasthenia Gravis CDE Revision History Document