In this session, the content of the new 2010 draft guidance is reviewed in detail. Perhaps more importantly, the implications of how this guidance affects the essential documentation practices and activities between the sponsor, investigator, and the reviewing IRBs are examined. Also covered is how the guidance fits in with other recent releases by the agency that promote implementing a risk-based approach for all stakeholders in performing their regulatory requirements for FDA regulated trials. For example, we will discuss the document's suggested expansion of the current sponsor IRB information exchange practices, which clarify the sponsor's role in regard to the IRB information submission that is vaguely spelled out in the regulations.
- Describe the history of what lead to the guidance release: risk-based focus
- Describe the recommendations regarding th criteria, process, and frequency of continuing review
- Identify how the guidance recommendations differ from current practices
- Discuss the implications of the guidance on IRB, investigator, and sponsor activities
- Review case scenarios, including recent warning letters
- Investigators & Site Managers
- Research Coordinators
- IRBs
- Clinical Research Associates
- Sponsor/CRO Managers
- Quality Assurance
Sandra "SAM" Sather, MS, BSN, CCRA, CCRC
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1.5 hours; 12:00 - 1:30 p.m. Eastern
January 12, 2011