CDE stands for "Common Data Element". The purpose of the CDE Project is to standardize the collection of investigational data 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 is to develop data standards for neuroscientific clinical research. Central to this project is the creation of common definitions and metadata 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 Division of Clinical Research is spearheading the effort to develop CDEs in neuroscience.
This website outlines these data standards and provides accompanying tools to help investigators and research teams use these CDE resources to collect and record standardized clinical data. For additional background information on the CDE effort objectives, please refer to the NINDS CDE Project Overview.
More infomation on the project is available:
To begin the NINDS CDE project, NINDS first developed a set of general CDEs that are 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 data elements, NINDS convenes working groups comprised of neurological disorder subject matter experts to develop sets of CDEs tailored to research involving specific diseases or disorders. These recommendations are available under the CDEs menu. Importantly, the NINDS CDE Project collaborates with other standards organizations to achieve its goals.
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 studies
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 Phase III (PAR-11-173) 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.
The CDE products are accessible via the following:
- Start here to find the General CDE standard sets that can be incorporated into your studies.
- Disease/disorder-specific CDEs can be found via the CDE menu at the top of the page.
- Users can employ these search tools to help find and assemble their data collection materials.
- These are designed to provide additional resources to those individuals with data management and/or database experience.
- Provides additional details about the NINDS CDE Project.
- Learn to navigate and use the NINDS CDE website.
- The NINDS CDE 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. HHSN271201700064C (Oct. 2017 - current), Contract No. HHSN271201200034C (Oct. 2012 - Sept. 2017) and Contract No. N01-NS-7-2372 (May 2002 - Sept. 2012).
- Download the NINDS CDE General Flyer.
- Please contact the NINDS CDE Team at NINDSCDE@emmes.com for the most recent updates.