The FDA announced in 2006 an initiative to modernize the regulation of clinical trials, including the BIMO inspections program. This includes conducting inspections and other assessments earlier in the development of a potential product to build quality into the clinical trial upfront rather than assessing it at trial completion. From this initiative, the FDA has generated new guidance and regulation that directly affect the performance of the research investigator and the research coordinator. The initiative is a dynamic process and this web seminar tracks the updates that directly affect the investigator and study staff. Examples of how to implement the agency requirements and recommendations into current practices and specific projects are also covered.
- Examine industry regulatory updates that impact the role of the Clinical Research Coordinator
- Integrate strategies for determining appropriate role delegation and documentation specific to a study project
- Apply tools and resources
- Clinical Research Coordinators
- Site Managers
- Quality Assurance Personnel
- Clinical Research Associates
Karen L. Gilbert, B.S., C.C.R.A.
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Hold this course at your company! For more information, contact Naila Ganatra at (215) 413-2471.