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U.S. Department of Health and Human Services


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CDER's Grant Program for Data Standards Development

CDER launched a grant program in May 2011to fund projects that develop disease/domain specific therapeutic area data standards. Funding preference has been given to projects that address existing data standards challenges and aim to create standards under the CDISC and HL7 processes. 

As of June 2013, CDER closed the current funding opportunity and is working on a revised announcement reflective of the experiences and success achieved to date.  More information about this update and how to reach the funding opportunity will be provided here when it is available.

The table below lists the awards that have been made under this program. Results are expected within one year of award for each project, unless extensions are granted.   Future awards are subject to release of the new announcement, receipt of qualified applications, and availability of funds.
Data Standards Grants Awarded

Project Title

Grant Awardee

Award Date/ Current Status

Advancing Regulatory Science through Novel Terminology and Standards Development (focus on standards development processes specific for therapeutic areas and the development of a Virology domain)

Dr. Rebecca Kush, CDISC
Sept 1, 2011/ Complete
Synthesis and Harmonization of High Impact Data Elements (focusing on Schizophrenia and is also collaborating on development of standards for collection of Cardiovascular Imaging data)
Dr. Meredith Nahm, DCRI
Sept 1, 2011/ Ongoing
Standardized Collection and Submission of Cardiovascular Endpoint Data
Dr. James Tcheng, DCRI
July 15, 2012/ Ongoing
Synthesis and Harmonization of High Impact Data Elements (focus on Cardiovascular Imaging)
Dr. Meredith Nahm, DCRI
Sept 21, 2012/ Ongoing
CDISC Standardization for Cardiovascular Imaging and Schizophrenia
Mr. Bron Kisler, CDISC
Sept 15, 2012/ Ongoing
Data Concepts and Terminology Standards in Cardiovascular Imaging
Dr. Pamela Douglas DCRI
Sept 15, 2012/ Ongoing
Development of Major Depressive Disorder Standard Data Elements
Dr. Meredith Nahm, DCRI
Sept 15, 2012/ Ongoing


Return to the CDER Data Standards Program