This course presents content and impact discussion of the new FDA and OHRP adverse event reporting guidance documents posted in 2007. The guidance documents address issues of adverse event information exchange between stakeholders and propose solutions to the issues of the quality of information being sent to the IRBs. The guidance impacts the activities of the research site, IRB, and Sponsor/CRO’s role in compiling and/or communicating adverse event information during a research study, changing the industry’s current practices.
- Appreciate the changing regulatory climate and the impact on safety reporting in clinical trials
- Explain the global response and recommendations for more meaningful safety reporting between stakeholders
- Describe FDA’s response: April 2007 Draft Guidance
- Describe OHRP’s response: January 2007 Final Guidance
- Recognize implications for current practices
- Examine case scenarios
- Sites: PIs, CRCs, Managers
- Sponsors: CRAs, Sponsor Clinical Operations,Safety Information Specialists, Regulatory
Sandra “SAM” Sather, M.S., B.S.N., C.C.R.A., C.C.R.C.
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1.5 hours; 12:00 - 1:30 p.m. Eastern
February 2, 2011