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Requirements for using ClinicalTrials.gov

December 14, 2012

Research that uses ClinicalTrials.gov must meet certain requirements related to registration and results reporting

The Food and Drug Administration Amendments Act of 2007 (FDAAA or US Public Law 110-85) requires mandatory registration and results reporting for applicable clinical trials that may be subject to FDA regulation under an investigational new drug application (IND) or investigational device exemption (IDE). Registration of of clinical trials is also a condition for research publication by The International Committee of Medical Journal Editors (ICMJE).

The individual who initiates and conducts the study, has access to and control over the data, and the right to publish the results of the trial for investigator initiated studies is deemed the “Sponsor-Investigator”. This individual is responsible registering the protocol record, updating the record every six months for active trials and entering final results within 12 months of the actual primary completion date of the protocol per FDAAA requirements.

Failure to comply with this regulation may result in significant penalties to the Principal Investigator.

For more information, please visit the OSU College of Medicine's Office of Research website.

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