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.
A one-page, fold-up
brochure is available for download.
More infomation on the project is available:
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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.
Note: All revisions or updates to the NINDS CDEs undergo a thorough review process
including approval by the disease-associated Oversight Committees* and/or NINDS
CDE Steering Committee prior to implementation.
*Disease Oversight Committees are listed under the History and Acknowledgements
tab on each disease page.
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
Researchers who receive funding from NINDS are asked to use the CDEs in their case
report forms (CRFs) and data management systems whenever possible. For clinical
trials and large epidemiological studies (PAR-13-281)
, the NINDS strongly encourages researchers who receive funding from the Institute
to use the NINDS Common Data Elements (CDEs) available on this site
or document how they will ensure their data collection is compatible with the CDEs.
Investigators should use the common definitions and the standardized case report
forms and other instruments identified by the CDE Project. The CDE Project has developed
uniform formats by which clinical data can be systematically collected, analyzed
and shared across the research community. Please see Terms of Award
for more information.
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.
However, any revisions or updates to the NINDS CDEs will undergo a thorough review
process including approval by the disease-associated oversight committees and/or
NINDS CDE Steering Committee prior to implementation.
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.