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Registering your NIDA-supported protocol on Clinical Trials.gov

The FDA Modernization Act of 1977 requires that NIH (and companies and universities) register all drug trials for serious or life threatening conditions. The NIH policy is that all NIH supported clinical trials will be registered regardless of whether or not the trial involves serious or life threatening conditions.

It is the responsibility of the Principal Investigator and the grantee organization to identify whether or not this funded research project must be registered. You are required to use the following definition in determining whether this research is/is not a clinical trial.

"The NIH defines a clinical trial as a prospective biomedical or behavioral research study of human subjects that is designed to answer specific questions about biomedical or behavioral interventions (drugs, treatments, devices, or new ways of using known drugs, treatments, or devices). Clinical trials are used to determine whether new biomedical or behavioral interventions are safe, efficacious, and effective. Behavioral human subjects research involving an intervention to modify behavior (diet, physical activity, cognitive therapy, etc.) fits these criteria of a clinical trial. Human subjects research to develop or evaluate clinical laboratory tests (e.g. imaging or molecular diagnostic tests) might be considered to be a clinical trial if the test will be used for medical decision-making for the subject or the test itself imposes more than minimal risk for subjects."

Contact the project officer assigned to your grant award to ensure that an account has been set up for you, then visit the following URL: http://prsinfo.clinicaltrials.gov to register your protocol.

Protocol Registration User’s Guide (PDF, 271KB)

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