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 Title | Grant Awardee | Award 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 Standards | Mr. Bron Kisler, CDISC | September 2015 |
| An Extendable Infrastructure for Building Broad Community Support Around Clinical Trial Measures | Dr. Carol Hamilton, Research Triangle Institute | September 2014 |
| Development of Bipolar and Generalized Anxiety Disorder Standard Data Elements | Dr. Meredith Nahm Zozus, Duke University | September 2014 |
| Development of Prostate Cancer Standards | Mr. Bron Kisler, CDISC | September 2014 |
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 | 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 Development | Dr. 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 CFAST | Dr. Enrique Aviles, C-Path | September 2013 |