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Clinical Trials

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Clinical Trials

There is a registry and results database of federally and privately supported clinical trials conducted in the United States and around the world. ClinicalTrials.gov is a service of the U.S. National Institute of Health and provides information about a trial's purpose, who may participate, locations, and phone numbers.

New Rules Pertaining to ClinicalTrials.gov

In September 2016, the U.S. Department of Health and Human Services issued a final rule that clarifies and expands the regulatory requirements for submitting registration and summary results information of clinical trials on ClinicalTrials.gov, in accordance with FDAAA 801. The final rule is intended to make it clear to sponsors, investigators, and the public which trials must be submitted, when they must be submitted, and whether compliance has been achieved. For example, the final rule clarifies the definition of an Applicable Clinical Trial and provides structured criteria for determining which studies meet the definition. The final rule also expands the FDAAA 801 requirements by requiring the submission of results information for trials of unapproved products. The regulation was put into effect on January 18, 2017 and responsible parties are expected to be in compliance as of April 19, 2017.

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