Drugs

CDER's Grant Program for Data Standards Development

CDER launched a grant program in May 2011 to 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.

On April 24, 2014 CDER published RFA-FD-14-004 seeking applications for projects to expedite development of data concepts and terminology to support human drug development and evaluation. In addition, a new funding opportunity announcement will be made available in FY15. Information about 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 to two years 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.

Ongoing Data Standards Grants

Project Title
Grant Awardee
Award Date
An Extendable Infrastructure for Building Broad Community Support Around Clinical Trial Measures
Dr. Carol Hamilton, Research Triangle Institute
Sept 14, 2014
Development of Bipolar and Generalized Anxiety Disorder Standard Data Elements
Dr. Meredith Nahm Zozus, Duke University
Sept 14, 2014
Development of Prostate Cancer Standards
Mr. Bron Kisler, CDISC
Sept 14, 2014
Strengthening the Operating Framework and Furthering the Objectives of CFAST
Dr. Enrique Aviles, C-Path
Sept 15, 2013
Data Concepts and Terminology Standards in Imaging to Support Human Drug Development
Dr. Daniel Rubin, Stanford University
Aug 1, 2013
CDISC Standardization for Cardiovascular Endpoints and Schizophrenia
Mr. Bron Kisler, CDISC
Sept 15, 2012
 

Completed Data Standards Grants

Project Title
Grant Awardee
Award Date
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
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
Standardized Collection and Submission of Cardiovascular Endpoint Data
Dr. James Tcheng, DCRI
July 15, 2012
Synthesis and Harmonization of High Impact Data Elements (focus on Cardiovascular Imaging)
Dr. Meredith Nahm, DCRI
Sept 21, 2012
Data Concepts and Terminology Standards in Cardiovascular Imaging
Dr. Pamela Douglas DCRI
Sept 15, 2012
Development of Major Depressive Disorder Standard Data Elements
Dr. Meredith Nahm, DCRI
Sept 15, 2012

 

Return to the CDER Data Standards Program

 

Page Last Updated: 10/20/2014
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