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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. You can use this tool to identify if your study meets the NIH definition of a clinical trial.
Clinical Trials Information and FAQs
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.
With the changes to the federal regulations governing human subjects research, implemented on January 21, 2019, clinical trials also need to post one informed consent form used to enroll subjects after the clinical trial is closed to recruitment, and no later than 60 days after the last study visit by any subject. The NIH Clinical Trials website is the location currently identified for this posting.
- Office of the Federal Register: Final Rule for Clinical Trials Registration and Results Information Submission (September 2016)
- NIH: Changes from Current Practice Described in the Final Rule (December 2016)
- NIH: Checklist and Elaboration for Evaluating Whether a Clinical Trial or Study is an Applicable Clinical Trial (Decembr 2016)
- NIH News Release: HHS takes steps to provide more information about clinical trials to the public (September 2016)
- Final Rule Webinar Series: View the archived content for the webinar series, designed to assist responsible parties further their understanding of the final rule
- Zarin DA, Tse T, Williams RJ, Carr S. Trial reporting in ClincialTrials.gov - the final rule. N Engl J Med. 2016 Nov 17;275(20):1998-2004. (Full Text)
- Hudson KL, Lauer MS, Collins FS. Toward a new era of trust and transparency in clinical trials. JAMA. 2016 Oct 4:316(13):1353-1354. (Full Text)
- FDA: Evaluating Inclusion and Exclusion Criteria in Clinical Trials (April 2018)