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 first set of Common Data Elements (CDEs) for Facioscapulohumeral 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.
The CDE Working Groups will be meeting until Fall 2014. Please contact the NINDS CDE Project Officer, Joanne Odenkirchen or
NINDSCDE@emmes.com for further information.
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.
- John T. Kissel, MD - Ohio State University, Columbus, OH, USA
- George W.A.M. Padberg, MD - Nijmegen, Netherlands
- Enzo Ricci, MD - Universita Cattolica del Sacro Cuore, Rome, Italy
- Sabrina Sacconi, MD - Centre Hopitalier Universitaire de Nice Sophia Antipolis, Nice, France
- Jeffrey Statland, MD - University of Kansas Medical Center, Kansas, USA
- Rabi Tawil, MD - University of Rochester Medical Center, Rochester, NY, USA
- Baziel G. M. van Engelen, MD - Neuromuscular Centre Nijmegen, Nijmegen, Netherlands
- Kathryn R. Wagner, MD, PhD - Kennedy Krieger Institute, Baltimore, MD, USA
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NIH Coordinating Team
- Robin Conwit, MD - National Institute of Neurological Disorders and Stroke (NINDS), National Institutes of Health (NIH)
- Elizabeth McNeil, MD, MSc - National Institute of Neurological Disorders and Stroke (NINDS), National Institutes of Health (NIH)
- Joanne Odenkirchen, MPH - NINDS CDE Project Officer, National Institutes of Health/National Institute of Neurological Disorders and Stroke (NIH/NINDS), Bethesda, Maryland, USA
- John Porter, PhD - National Institute of Neurological Disorders and Stroke (NINDS), National Institutes of Health (NIH)
- Yaffa Rubenstein PhD - NCATS/NIH
- Tiina Urv, PhD - NICHD/NIH
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NINDS CDE Team
- Sherita Ala'I, MS - The EMMES Corporation, Rockville, MD, USA
- Marybeth Montoro, MPH - 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.