On September 16, 2016, the Department of Health and Human Services (HHS) issued a new regulation and the NIH has issued a new policy to increase the availability of information about clinical trials. The HHS Final Rule describes requirements for registering and submitting summary results information for certain clinical trials to ClinicalTrials.gov. A complimentary NIH policy that applies to all clinical trials funded by NIH, regardless of whether they are subject to the Final Rule was also published. The Final NIH Policy was published in the NIH Guide for Grants and Contracts.
ClinicalTrials.gov is offering a series of live webinars, on October 5 and October 11, to provide responsible parties with information about the Final Rule. Each webinar will cover a different aspect of the Final Rule, including an overview of which applicable clinical trials are covered, what clinical trial registration and results information is required under the “expanded” requirements, and when the requirements take effect.