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. Currently, the
subject-specific working groups are developing these data elements. The set of Common Data Elements (CDEs)
for Congenital Muscular Dystrophy will be available in January 2015.
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.
Once developed, the CDEs are organized by domains and sub-domains, often used in clinical studies, data standards include:
- CDEs — Classified as Core,
Supplemental, or Exploratory
- CRF Modules — logically organize CDEs for data collection
- Guidelines — to provide further information about the CDEs.
In the interim, we have a set of CDEs created in collaboration between the NINDS and Cure CMD.
These CDEs are tailored specifically for a CMD natural history study and may be reused as appropriate.
Download Congenital Muscular Dystrophy (CMD) CDE Package
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
The NINDS CDE Team has requested, and in many cases received, permission to post
proprietary instruments/scales recommended by the CDE Working Groups to this site.
When permission is granted, the documents are posted in the exact format they were
received in order to maintain the validity of the instrument. If approval is not
granted for the instrument to be reproduced on this site, with the author/copyright
holder’s permission, a link is posted to an external Web site where users can get
more information about the instrument. If you have difficulty accessing either the
proprietary instruments/scales or the external links, please contact the
NINDS CDE Project Officer, Joanne Odenkirchen.
CMD Working Group
- Angela Giacoletti Argento, PhD - University of Michigan Hospital and Health Systems, Ann Arbor, MI, USA
- Carsten G. Bonnemann, MD - NIH, Bethesda, MD, USA
- Jim J. Collins, MD, PhD - Cincinnati Children's Medical Center, Cincinnati, OH, USA
- James Dowling, MD, PhD - The Hospital for Sick Children, Toronto, Ontario, Canada
- Susan T. Iannaccone, MD, FAAN - University of Texas Southwestern Medical Center, Dallas, TX, USA
- Chamindra Konersman, MD - Medical College of Wisconsin, Milwaukee, WI, USA
- Michael W. Lawlor, MD, PhD - Medical College of Wisconsin, Milwaukee, WI, USA
- Kathy Mathews, MD - University of Iowa Children's Hospital, Iowa City, IA, USA
- Fancesco Muntoni, MD - University College London, Institute of Child Health-Dubowitz, London, UK
- Susan E. Sparks, MD, PhD - Levine Children's Hospital, Charlotte, NC, USA
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NIH Coordinating Team
- Robin Conwit, MD - NINDS/NIH, Bethesda, MD, USA
- Petra Kaufmann, MD, MSc - NINDS/NIH, Bethesda, MD, USA
- Elizabeth McNeil, MD, MSc - NINDS/NIH, Bethesda, MD, USA
- Joanne Odenkirchen, MPH - NIH/NINDS, Bethesda, MD, USA
- John Porter, PhD - NINDS/NIH, Bethesda, MD, USA
- Yaffa Rubinstein, Ph.D. - NIH, Bethesda, MD, USA
- Tiina K. Urv, Ph.D. - Inational Institute of Child Health and Human Development, NIH, Bethesda, MD, USA
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NINDS CDE Team
- Sherita Ala'I, MS - The EMMES Corporation, Rockville, MD, USA
- Joy Esterlitz, MS - The EMMES Corporation, Rockville, MD, USA
- Marybeth Montoro, MPH, CPH - The EMMES Corporation, Rockville, MD, USA
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Note: Institutions for all individuals acknowledged in this section
were those they belonged to when they joined the Committee. All Committee
members were asked to voluntarily disclose all potential sources of bias in their
involvement with the NINDS CDE Project. The summary disclosure information is available
upon request by contacting NINDSCDE@emmes.com.