Food and Drug Administration

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, FDA’s 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.

Who can apply

• Public and State controlled institutions of higher education
• Nonprofits with 501(c)(3) status (other than higher education)
• Nonprofits without 501(c)(3) status (other than higher education)
• Private institutions of higher education
• For-profit organizations other than small businesses
• Small businesses

Contact

Eric Bozoian <br/>Grants Management Specialist <br/>Phone 2404027623
eric.bozoian@fda.hhs.gov