NINDS Common Data Elements Harmonizing information. Streamlining research.

CDE stands for "Common Data Element." The purpose of the CDE Project is to standardize the collection of investigational data in order to facilitate comparison of results across studies and more effectively aggregate information into significant metadata results.

The goal of the National Institute of Neurological Disorders and Stroke (NINDS) CDE Project specifically is to develop data standards for clinical research within the neurological community. Central to this project is the creation of common definitions and data sets so that information (data) is consistently captured and recorded across studies.

The NINDS, part of the National Institutes of Health (NIH), is the leading funder of clinical studies of the brain and nervous system in the United States. To harmonize data collected from clinical studies, the NINDS Office of Clinical Research is spearheading the effort to develop CDEs in neuroscience.

This Web site outlines these data standards and provides accompanying tools to help investigators and research teams collect and record standardized clinical data. For additional background information on the CDE effort objectives, please refer to the NINDS CDE Project Overview presentation (1.7MB PPT).

More infomation on the project is available:

• Types of Available CDEs
• Benefits of CDEs
• CDE Products
• References
• Feedback and Suggestions

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NINDS first developed a set of general CDEs commonly collected in all clinical studies regardless of the type of study or therapeutic area. Examples of the General CDEs include medical history data; scores on neurological assessments; demographic information (e.g., date of birth/ age, race, ethnicity); and details about medications used by participants throughout a study.

In addition to the general elements, NINDS has also developed sets of CDEs tailored to research involving specific diseases or disorders. The Standards menu lists the diseases or disorders for which CDE data sets have already been developed. NINDS will continue to convene working groups to create CDEs for other neurological diseases. Importantly, the CDE Project continues to collaborate with other standards organizations to achieve its goals.

The CDE Project is a resource to help clinical investigators employ standardized data collection techniques as they design and conduct new clinical studies. The use of CDEs in investigational neuroscience will help:

• Reduce the time and cost needed to develop data collection tools
• Promote standardized, consistent, and universal data collection
• Improve data quality
• Facilitate data sharing
• Improve opportunities for meta-analysis and comparison of results from different studies

While the use of CDEs is not currently a requirement, researchers who receive funding from NINDS are asked to use the CDEs in their case report forms (CRFs) and data management systems whenever possible (PAR-11-173 and PAR-10-199). The CDEs do not include all variables that clinical investigators may need to collect in a particular study. NINDS recognizes that the most important outcome variables collected by a study may not be incorporated into existing CDEs. However, the CDE Project is continually developing new data elements in order to increase the efficiency and consistency of data collection and to promote data sharing. The CDE Project still permits the inclusion of innovative, creative, and unique data elements by allowing investigators to independently identify and add their own critical variables.

These CDE standards and tools are designed to assist researchers in the various stages of design, implementation, and interpretation of their clinical study data. Researchers designing studies and preparing grant applications will find a core set of data elements, definitions, and sample case report forms. The NINDS CDE standards and tools also provide researchers with standardized definitions and prefabricated arrays of permissible data elements.

The CDE products are accessible via the following:

• CDEs
  • Start here to find the CDE standard sets that can be incorporated into your studies.
  • This resource is divided into disease specific standards as well as the General CDEs.
• Tools
  • Experienced users can employ these tools to help assemble their data collection materials.
  • These are designed to provide additional resources to those individuals with data management and/or database experience.
• Learn
  • Provides additional details about the CDE Project.
  • How data elements are designated as NINDS CDEs.

• This Project has been funded in whole or in part with Federal funds from the National Institute of Neurological Disorders and Stroke, National Institutes of Health under Contract No. N01-NS-7-2372.
• Download the NINDS CDE Project brochure (300k PDF)
• Annals of Neurology article about CDEs: NerveCenter: NINDS common data element project: A long-awaited break through in streamlining trials. Annals of Neurology. Vol. 68 No. 1 (June 2010), pp. A11 - A13.
• Grinnon ST, Miller K, Marler JR, Lu Y, Stout A, Odenkirchen J, Kunitz S. National Institute of Neurological Disorders and Stroke Common Data Element Project - approach and methods. Clin Trials. 2012 Feb 27. [Epub ahead of print]