The recent changes in National Institutes of Health/Health and Human Services (NIH HHS) requirements (Final Rule) for registration of clinical trials and submission of results information will apply to all clinical trials of medicinal products (including Biologics) and device products. This Final Rule clarifies and expands the requirements for registration and submission of data from clinical trials. The Final Rule also outlines the potential civil or criminal actions which may be taken by the regulatory agency for non-compliance.
This final rule is a mandatory piece of your clinical studies that, if ignored, will irreparably harm or even destroy your trials. Fortunately, we have broken down the final rule into a digestible, convenient format that will put you and your studies on the road to compliance.
By attending this 90-minute presentation you will learn…
- The requirements set forth in the new Final Rule to enable you to prepare yourself for compliance
- Who the “responsible party” is
- The new required format for protocol submission
- The new formats for reporting clinical trial results and adverse events
- The current timeframes for registering and updating ClinicalTrials.gov