This course will review the content of the 2012 final guidance for continuing review of Institutional Review Board (IRB) approved research. In response to changes within the industry and the conduct of clinical research, the FDA highlights an updated approach to sponsor, IRB, and Clinical Investigator interaction by encouraging investigators and sponsors to ensure that IRBs receive meaningful study-wide information, particularly when doing so may assist IRBs in reviewing the studies and protecting subjects. This guidance also recommends particular areas where IRBs should focus to ensure meaningful review and approval. In this web seminar, the implications of how this guidance affects the essential documentation practices and activities between the sponsor, investigator, and the reviewing IRBs will be examined.
- Describe the history of what led to the guidance release and its risk-based focus
- Describe the recommendations regarding the criteria, process, and frequency of continuing review
- Identify how the guidance recommendations differ from current practices
- Discuss the implications of the guidance on sponsor, investigator, and IRB activities
- Review case scenarios, including recent warning letters
- Site Managers
- Research Coordinators
- IRB Professionals
- Clinical Research Associates
- Regulatory Professionals
- Sponsor/CRO Managers
- Quality Assurance Personnel
Elizabeth Ronk Nelson, M.P.H.
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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 1-800-856-2556 for pricing.
Barnett International is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education. Participants will receive 1.5 hours (0.15 CEUs) of continuing education credit for full participation, including the completion of a pre-test, post-test, and program evaluation. Barnett International will mail ACPE statements within three weeks of program completion. ACPE#: 0778-0000-12-073-L01-P. Released: 7/12.
Hold this course at your company! For more information, contact Naila Ganatra at (215) 413-2471.