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.
Click here for complete trainer
biographies
$835
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.
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.