XI Clinical Trials.gov
Principal investigators are responsible for registering and reporting results of all clinical trials in a publicly accessible registry. This includes reviewing the record for accuracy and ensuring data-entry occurs within required time frames, as set forth by FDAAA, NIH, CMS, and ICJME, as per these policies and regulations.
The NIH defines a Clinical Trial as “a research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes.”
See how to register your clinical trial in clinicaltrials.gov or contact Rebecca Chen (Rutgers ClinicalTrials.gov Protocol Registration System Administrator) to assist with the registration process and answer any questions.
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