The U.S. Department of Health and Human Services today issued a final rule (link is external) that specifies requirements for registering certain clinical trials and submitting summary results information to ClinicalTrials.gov. The new rule expands the legal requirements for submitting registration and results information. At the same time, the National Institutes of Health has issued a complementary policy (link is external) for registering and submitting summary results information to ClinicalTrials.gov for all NIH-funded trials, including those not subject to the final rule. A news release includes links that provides summaries and a table to better understand the changes.
Important elements of the final rule include:
- Providing a checklist for evaluating which clinical trials are subject to the regulations and who is responsible for submitting required information;
- Expanding the scope of trials for which summary results information must be submitted to include trials involving FDA-regulated products that have not yet been approved, licensed, or cleared by the FDA;
- Requiring additional registration and summary results information data elements to be submitted to ClinicalTrials.gov, including the race and ethnicity of trial participants, if collected, and the full protocol;
- Requiring additional types of adverse event information; and
- Providing a list of potential legal consequences for non-compliance.
Post from Midcontinental Region News. Used with permission.