The Importance of Clinical Trial Transparency & Compliance with the Final Rule & NIH Policy on Clinical Trials Registration & Results Information

Led by Kathy Hudson, PhD, deputy director for science, outreach, and policy, NIH and Rob Califf, MD, commissioner, FDA, last week’s webinar explained that the federal government is cracking down on the requirement that clinical trials must be registered and results reported in clinicaltrials.gov for all clinical trials funded by NIH. This will "ensure that information about clinical trials and their results are made publicly available in a timely manner. The Final Rule has a compliance date of 90 days after January 18, 2017, meaning that a responsible party has until that date to come into compliance with the requirements of the rule. Failure to comply with the regulation may have legal consequences.”

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