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.

Information about future funding opportunities will be provided here, when 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 an extension is granted. Future awards are subject to release of a new announcement, receipt of qualified applications, and availability of funds.

Questions related to the CDER data standards grant program should be sent to CDERdatastandards@fda.hhs.gov.
 

Ongoing Data Standards Grants

Project TitleGrant AwardeeAward Date
Improved Data Standards for Animal Efficacy Studies and Natural History Studies for Animal Rule Applications
Mr. Jonathan Neville, Critical Path Institute 
September 2016
Architectural Review of the BRIDG Model
Ms. Smita Hastak, Samvit Solutions LLC 
September 2016
Development of a CDISC Therapeutic Area Standard for Lung Cancer
Mr. Bron Kisler, CDISC
September 2016
Therapeutic Area Data Standard for Clostridium Difficile associated Diarrhea 
Ms. Elizabeth LeRoy, Critical Path Institute 
September 2016
Therapeutic Area Data Standard for Treatment of HIV
Mr. Jonathan Neville, Critical Path Institute 
September 2016
Development of Colorectal Cancer StandardsMr. Bron Kisler, CDISC
September 2015
An Extendable Infrastructure for Building Broad Community Support Around Clinical Trial MeasuresDr. Carol Hamilton, Research Triangle Institute 
September 2014
Development of Bipolar and Generalized Anxiety Disorder Standard Data ElementsDr. Meredith Nahm Zozus, Duke University
September 2014
Development of Prostate Cancer StandardsMr. Bron Kisler, CDISC 
September 2014
 

Completed Data Standards Grants

Project TitleGrant AwardeeAward 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
September 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
September 2011
Standardized Collection and Submission of Cardiovascular Endpoint Data
Dr. James Tcheng, DCRI
July  2012
Synthesis and Harmonization of High Impact Data Elements (focus on Cardiovascular Imaging)
Dr. Meredith Nahm, DCRI
September 2012
Data Concepts and Terminology Standards in Cardiovascular Imaging
Dr. Pamela Douglas DCRI
September 2012
Development of Major Depressive Disorder Standard Data Elements
Dr. Meredith Nahm, DCRI
September 2012
Data Concepts and Terminology Standards in Imaging to Support Human Drug DevelopmentDr. Daniel Rubin, Stanford University
August 2013
CDISC Standardization for Cardiovascular Endpoints and Schizophrenia Mr. Bron Kisler, CDISC
September 2012
Strengthening the Operating Framework and Furthering the Objectives of CFASTDr. Enrique Aviles, C-Path
September 2013

Return to the CDER Data Standards Program

 

Page Last Updated: 11/04/2016
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