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What NIH Grantees Need to Know About ClinicalTrials.gov and FDAAA

NIH’s Office of Extramural Research has a new web site that provides information to help NIH applicants and grantees (recipients of extramural grants and cooperative agreements)  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.

The site is available at: http://grants.nih.gov/ClinicalTrials_fdaaa/index.htm.

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