Course Description________________________
FDA announced in 2006 an initiative to modernize the regulation of clinical trials, including the BIMO, inspections program. This includes 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, 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 course tracks the updates that directly affect the investigator and study staff, applying these to the session prior to each offering. Examples are included for how to implement the agency requirements and recommendations into current practices and specific projects.
Learning Objectives____________________________
- Examine industry regulatory update impacting the role of the CRC
- Integrate strategies for determining appropriate role delegation and documentation specific to a study project
- Apply tools and resources
Who Should Attend_______________________
CRCs
Investigators
Site Managers
CRA
QA Personnel
Instructor ________________________________
Sandra “SAM” Sather, MS, BSN, CCRA, CCRC
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Course Length and Time___________________
2.0 hours 12:30 - 2:30 p.m. Eastern
Course Dates _____________________________
March 31, 2010
Fee_______________________________________
$595
This registration fee is valid for up to 20 participants at your site. This includes one login for your site to the live event for up to 20 participants, access to the teleconference phone number, a PDF copy of the presentation slides, and ACPE accreditation for participants who complete the pre- and post-test requirements. For teams with more than 20 participants, please call for pricing.
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Accreditation______________________________
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 mail ACPE statements within three weeks of program completion. ACPE#: 778-000-09-050-L04-P. Released: 3/10.
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For more information, contact Naila Ganatra at (215) 413-2471.