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Therapeutic Areas for Data Standards Development (U01)

Post Date

April 1st 2016

Application Due Date

June 3rd 2016

Funding Opportunity Number


CFDA Number(s)


Funding Instrument Type(s)

Cooperative Agreement

Funding Activity Categories

Consumer Protection
Food and Nutrition

Number of Awards


Eligibility Categories

Public and State Controlled Institutions of Higher Education
Non-Profits With 501 (c) (3) Status With The IRS (Except Higher Education Institutions)
Non-Profits Without 501 (c) (3) Status With The IRS (Except Higher Education Institutions)
Private Institutions of Higher Education
For-Profit Organizations (Except Small Businesses)
Small Businesses

Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply. Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply. Foreign components, as defined in the HHS Grants Policy Statement, are not allowed.


  • Estimated Total Funding:


  • Award Range:

    $None - $225000

Grant Description

Establishing common study data standards will provide new opportunities to transform the vast and continually increasing amount of clinical study data received into useful information to speed the delivery of new therapies to patients. Standardized data elements, terminologies, and data structures enable automation of important analyses of clinical study data to support more efficient and effective regulatory decision-making. In 2011, in response to an urgent need to further standardize study data terminologies and concepts for efficacy analysis, FDAмs Center for Drug Evaluation and Research (CDER) compiled a prioritized list of disease and therapeutic areas (TAs) for which additional data standardization was needed, and made the list available on the FDA website. The primary objective of this funding opportunity is to support projects leading to the development of specifications for TAs which capture how to structure commonly collected data and outcome measurements in disease clinical trials.

Contact Information

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