ClinicalTrials.Gov Requirements: Clinical Trial Registration and Trial Results Reporting, Expanded Registry and Results Data Bank
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
Who Should Attend
- Trial Managers
- Project Managers/Directors
- Clinical Quality Assurance/Compliance Personnel
- Principal Investigators
- Regulatory Professionals
- Clinical Operations Professionals
Elizabeth Ronk Nelson, M.P.H.
Includes up to 20 participants at one site. All participants (up to 20) are eligible for “Certificates of Attendance,” and accreditation, provided that accreditation requirements are met. For groups larger than 20 or for additional sites, please call +1 781.972.5400 or toll-free in the U.S. 800.856.2556 for pricing.
Note: Due to COVID-19, we understand that most teams cannot currently dial-in together. As such, we are able to offer additional logins at a highly reduced rate. Please contact Barnett Customer Service at +1 781.972.5400 or toll-free in the U.S. 800.856.2556 to register with your additional participants requiring login credentials. Or email Customer Service at: firstname.lastname@example.org
Barnett International is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education. Participants will receive 2 hours (0.2 CEUs) of continuing education credit for full participation, including the completion of a pre-test, post-test, and program evaluation. Barnett International will issue a receipt of completion for earned CEUs within three weeks of program completion. ACPE#: 0778-0000-20-027-L01-P. Released: 2/20.
Hold this course at your company! For more information, contact Naila Ganatra at +1 215.413.2471.