The purpose of the U.S. Department of Health and Human Services (HHS) final rule is to clarify and expand the requirements for the submission of clinical trial registration and results information to the ClinicalTrials.gov database. This web seminar reviews the new requirements published in September 2016, under FDAAA 801 and 42 CFR Part 11, with an implementation date of January 2017, for applicable clinical trials: Submitting registration and clinical trial summary results information, including adverse event information, of drug products (including biological products) and device products to ClinicalTrials.gov. Discussion of the expanded registry and results data bank will be provided along with a summary of all trial registration and results reporting requirements.
- Explain the role and expectations of the responsible party
- List clinical trial registration requirements
- Identify two trial documents that are required to be submitted with the clinical trial results information
- Describe the trial results reporting requirements for unapproved/unlicensed/uncleared products and approved products
- Trial Managers
- Project Managers/Directors
- Clinical Quality Assurance/Compliance Personnel
- Principal Investigators
- Regulatory Professionals
- Clinical Operations Professionals
Elizabeth Ronk Nelson, M.P.H.
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Hold this course at your company! For more information, contact Naila Ganatra at +1 215.413.2471.