PL 110-85 enacted September 27, 2007 amends the Public Health Service Act to expand the scope of clinical trails that must be registered in ClinicalTrials.gov. It increases the number of registration fields, requires certain results information to be included and sets penalties for noncompliance. Click here for statutory definition of applicable clinical trials. NIH encourages registration of all trails whether reuired under the law or not. The entity responsible for registering is the “responsible party”. The statute defines the responsible party as the sponsor of the trial or the principal investigator if so designated by a sponsor, grantee, contractor, or awardee. Penalties for responsible parties who fail to register, or provide false or misleading information in connection with applicable clinical trials are significant and may include civil monetary penalties and for federally-funded trials, the withholding or recovery of grant funds. Trials may be registered directly at the protocol registration system section of the Clinical Trials website.
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