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When Does a Study Need to Be Registered?

By law, per FDA regulations, registration of Applicable Clinical Trials is required to occur within 21 days of first subject enrollment.

ICMJE guidelines require that clinical trials are registered before the first subject is enrolled in a trial.

However, as of May 1, 2012, Dartmouth requires registration of all applicable trials into the ClinicalTrials.gov database prior to study activation by the Dartmouth Clinical Trials Office, to ultimately satisfy both the law and ICMJE requirements.

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