The Common Data Element project so far…

nindsThe Common Data Elements (CDEs) project initiated by the NINDS is currently underway. The different committees have been meeting according to schedule (described below) to work on their assigned topics. The Common Data Elements project is a way to begin to standardize patient aspects of the disease, so that research can become comparable between studies and that precise patient information can be analyzed to draw conclusions about the disease. Previously, we have updated the community on the launch of this project, including the eleven categories being considered for developing the CDE for ME/CFS. Here we expand further on the nature, objectives, goals and timelines of this effort as described by the NINDS who initiated the development of project, working alongside CDC in leading this large-scale undertaking. Of note, SMCI participates directly through Dr. Zaher Nahle, CSO and VP for Research, in this project and two of our board members also serve on the Working Group. Notably, all our RAC members with expertise in ME/CFS are also part of this national effort, including Drs. Komaroff, Montoya, Rowe, Levine, Bateman and Hanson.


What is the CDE Project?

  • NINDS initiated the development of Common Data Elements (CDEs) as part of a project to develop data standards for funded clinical research.
  • The CDEs are content standards that can be applied to various data collection models and are intended to be dynamic and may evolve over time.
  • CDEs are not a database.

What are the objectives of the CDE Project?

  • Identify CDEs used in clinical research (age, gender, race, etc.)
  • Present data elements in a standard format available to all
  • Identify common definitions (including permissible values, range checks, etc.)
  • Standardize CRFs, when needed, and instruments
  • Provide information to researchers for clinical data collection and sharing

What are the goals of the CDE Project?

  • Develop common definitions and standardize case report forms (CRF) and other instruments
  • Help investigators conduct clinical research through the development of these uniform formats by which clinical data can be systematically collected, analyzed and shared across the research community

What is the Timeline of ME/CFS CDEs

  • January 23 and February 13, 2017
    • Orientation teleconferences ((victor – please note these are sub-bullets and format accordingly))
  • February 2017
    •  All members split into subgroups
    •  Chairs for each Subgroup designated
  • March – June 2017
    • Working Group members work on their respective subgroup assignments
    • Monthly meetings are scheduled for each subgroup
    • Main contact:
  • June – July 2017
    • Internal review
  • July – August 2017
    • Public review
  • September 2017
    • Posting of ME/CFS CDEs on the NINDS CDE Website

Like any large-scale project with a great number of participants some committees are moving faster than others but it is expected that the outcome of this project will be a significant step forward in understanding ME/CFS.