New Webpage for Grantees about ClinicalTrials.gov and FDAAA
A cross-post from the HSML list: This website will be important for health professionals who apply for NIH funding.
What NIH Grantees Need to Know About ClinicalTrials.gov and FDAAA
Why a site for NIH grantees?
This Web site provides information to help NIH applicants and grantees (recipients of extramural grants and cooperative agreements) to understand their roles and responsibilities in relation to ClinicalTrials.gov and the Food and Drug Administration Amendments Act (FDAAA) of 2007. The information on this site may not apply to NIH contracts or NIH intramural research.
This site includes:
* an overview of FDAAA and its relationship to certain trials funded through NIH grants and cooperative agreements;
* an overview of registration and results reporting requirements;
* instructions for providing the NIH with certification of compliance with FDAAA; and
* FAQs for NIH grantees, definitions and acronyms, and other resources.