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Clinical Trials Contracting

ClinicalTrials.gov

The Public Health Service Act as amended by Public Law 110-85 in September, 2007 expanded the scope of clinical trials that must be registered on ClinicalTrials.gov. The amendment required both drug and device trials to be registered on ClinicalTrials.gov. The International Committee of Medical Journal Editors requires that all Phase I studies be registered if consideration for publication is anticipated, effective July 2008.

For more information see the ClinicalTrials.gov FAQ in the "Tool Kit" on the right side of this page.

Instructional Information:

Trials that must be registered are called "applicable clinical trials." These trials include:

Trials of Drugs and Biologics – controlled, clinical investigations, other than Phase I investigations, of a product subject to FDA regulation (Phase II- IV trials now require registration)

Trials of Devices – controlled trials with health outcomes, other than small feasibility studies, and pediatric post-market surveillance.