Why has the National Institutes of Health (NIH) established ClinicalTrials.gov?
The ClinicalTrials.gov information resource was initiated as a result of the Food and Drug Administration Modernization Act of November 1997. The legislation requires the Department of Health and Human Services, through the NIH, to establish a registry of clinical trials for both federally and privately funded trials “of experimental treatments for serious or life-threatening diseases or conditions.” How are study protocols submitted to ClinicalTrials.gov? The FDA Guidance Document (March 2002) (http://www.fda.gov/cder/guidance/4856fnl.htm) describes the submission criteria. The NLM has developed the Protocol Registration System (PRS), a Web-based tool for submitting information to ClinicalTrials.gov. Study sponsors or their representatives may register online to apply for a PRS account (http://prsinfo.clinicaltrials.gov/). ClinicalTrials.gov facts • Completely confidential. No registration or personal identification is required. • Includes thousands of trials sponsored by the U.S. NIH
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