NINDS

NINDS

NINDS

www.commondataelements.ninds.nih.gov

Common 

Data 

Element 

Project

Harmonizing information. Streamlining research.

The use of CDEs is expected to reduce study

start-up times and accelerate analysis of data.

Common 

Data 

Elements Harmonizing information. Streamlining research.

Common 

Data 

Elements Harmonizing information. Streamlining research.

U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES 

National Institutes of Health

National Institute of Neurological Disorders and Stroke

NIH Publication No. 12-7501

August 2012

Common 

Data 

Elements Harmonizing information. Streamlining research.

NINDS_2012_CDE_Brochure_V3.indd 1-3 8/14/12 3:28 PM
What is the CDE Project?

What CDEs are being developed?

NINDS first developed a set of general CDEs commonly collected in 

all clinical studies regardless of the type of study or therapeutic area. 

Examples include medical history data; scores on neurological 

assessments; demographic information (e.g., age, race, ethnicity and 

educational level); and details about medications used by patients 

throughout a study.

In addition to these core elements, NINDS is also developing separate sets 

of CDEs tailored to research on specific diseases or disorders. Currently,

the project has included work on the following areas:

What groups are collaborating with NINDS?

For more than a year, NINDS has conducted working groups 

representing expertise in different areas of neuroscience addressing core 

and disease-specific elements. Participants included U.S. and international experts from leading academic and governmentresearch centers.

For example, in developing CDEs for traumatic brain injury research 

NINDS collaborated with the Defense Centers of Excellence for 

Psychological Health and Traumatic Brain Injury (DCoE), the 

Department of Veterans Affairs (VA), the Defense and Veterans

Brain Injury Center (DVBIC), and the National Institute on Disability

and Rehabilitation Research (NIDRR).

The National Institute of Neurological Disorders and Stroke 

(NINDS), part of the National Institutes of Health (NIH), is the 

nation’s leading funder of clinical studies of the brain and nervous

system. To harmonize data collected from clinical studies, the

n Spinal cord injury (SCI) n Traumatic brain injury (TBI) n Epilepsy

n Stroke

n Parkinson’s disease (PD) n Friedreich’s ataxia

n Multiple sclerosis n Huntington’s disease (HD) n Amyotrophic lateral sclerosis

(ALS)

n Headache n Neuromuscular disorders

NINDS recognizes that the best way to ensure CDEs remain current 

is to revise and extend the project based on feedback from the 

neurological community according to changes and advances in the 

clinical research landscape.

NINDS Office of Clinical Research is spearheading a project to 

develop common data elements (CDEs) in neuroscience.

The use of CDEs is expected to reduce study start-up times and 

accelerate data sharing among clinical investigators. Central

to the project is the identification of common definitions and 

the standardization of case report forms and other instruments. 

The CDE project will develop uniform formats by which clinical 

data can be systematically collected, analyzed and shared

across the research community.

NINDS will continue to convene working groups to address CDEs 

for other neurological diseases as needed.

How will CDEs help clinical investigators?

The CDE project is a resource to help clinical investigators stop 

reinventing the wheel as they launch new studies. The use of CDEs 

across clinical neuroscience will help:

n Reduce the time and cost needed to develop data collection tools

n Promote data collection in a consistent manner

n Improve data quality

n Facilitate data sharing

n Improve opportunities for meta-analyses and comparison of results 

from different studies

n Increase the availability of data forthe planning and design of new trials

The use of CDEs is not a requirement currently, butresearchers who 

receive funding from NINDS must ensure that their data collection is 

compatible with the CDE project (see NINDS PAR-11-173 and NINDS 

PAR-10-199 for more information). In addition, CDEs do not include all 

variables that clinical investigatorsmayneed tocollectin aparticular study.

What is the website for the CDE project?

www.commondataelements.ninds.nih.gov

The site includes neurology data standards, an overview of the 

development of the data standards for each of the disorders 

currently in the system, references and acknowledgements of the

people who have participated in the development, and an opportunity 

to make a comment or query the CDE teams. NINDS will continue to 

update the site with additional CDE materials, data dictionaries, new 

forms and other updates.

NINDS_2012_CDE_Brochure_V3.indd 4-6 8/14/12 3:28 PM