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NHLBI Research and Policy Update
Number 60s     Special January 22, 2009 Supplement

Reporting Clinical Trial Results to

This section provides information on who may be responsible for submitting clinical trial summary results to, what type of trials must be reported, and how to report the results.

U.S. Public Law 110-85 [PDF: 156 pages] (Food and Drug Administration Amendments Act of 2007 or FDAAA), Title VIII, Section 801 mandates that a "responsible party" (i.e., the sponsor or designated principal investigator) register and report results of certain "applicable clinical trials." It is important for investigators to determine whether they are subject to the law and, if so, to be sure that they have carried out their responsibilities for submitting summary results from the trial. Failure to comply with Title VIII of FDAAA can result in civil penalties, including the withdrawal of NIH funding.

"Applicable clinical trials" generally include:

  • Trials of Drugs and Biologics: Controlled, clinical investigations, other than Phase I investigations, of a product subject to FDA regulation;

  • Trials of Devices: Controlled trials with health outcomes of a product subject to FDA regulation (other than small feasibility studies) and pediatric postmarket surveillance studies.
In other words, "applicable clinical trials" include interventional studies (with one or more arms) of drugs, biological products, or devices that are subject to FDA regulation, meaning that the trial has one or more sites in the U.S, involves a drug, biologic, or device that is manufactured in the US (or its territories), or is conducted under an investigational new drug application (IND). Complete statutory definitions and more detailed information on the agency's current thinking [PDF: 9 pages] about their meaning are available.

To gain a better understanding of what will be involved in reporting summary results; responsible parties are encouraged to review the documents under “Basic Results Database” at

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