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Clinical Trials Registry On September 27, 2007, President Bush signed into law the Food and Drug Administration Amendments Act of 2007. Under this law, the registry requirements for clinical trials in the United States was greatly expanded. The new law requires that all ‘applicable’ drug and device trials are to be registered with ClinicalTrials.gov, a database supported by the National Institutes of Health. Applicable drug trial: All drug trials, except for Phase I studies Applicable device trial: All device trials, except for feasibility studies As of 2005, the
International Committee for Medical Journal Editors (ICMJE) requires that
applicable clinical trials be registered in a national registry in order for
publication. There is a list of journals that are requiring registration and
can be found at the following website:
www.icmje.org
In order to comply with the law, all applicable clinical trials must be registered on ClinicalTrials.gov no later than 21 days after the first subject is enrolled. However, some journals require that a study be registered prior to the first subject being enrolled or a manuscript will not be accepted. Please check with your journal to see if this more stringent rule applies. For help registering your trial or any questions/concerns, please contact the following:
Helpful Links:
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