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Cip Preparation Course

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CIP Preparation Course Summer 2008 Project Lead: Susan Rose, Ph.D. Office for the Protection of Research Subjects Instructors: Darcy Spicer, Frances Richmond, Kathy Hurtado, Sandy Jean, Kristin Craun, Susan Rose, Peter Mestaz, Gordon Olacsi, Marlene Krammer HRA 7th Floor, Conference Room Weekly on Mondays from 4:30pm – 6:00pm From June 16, 2008 – August 18, 2008. Genora Baker, John Revilla, RoseAnn Fleming, Nasairah Carter, Marie Reyes, Scott Maul

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Course Objectives: The objective of this course is to provide IRB staff with the necessary tools, information, training, and support needed to prepare for and successfully pass the Certified IRB Professional (CIP) examination. Course Content Week 1 (6/16/08) Lecture Content and Speaker(s) Introduction, Overview, History, Common Terminology (Susan, Gordon, Peter) HHS/OHRP regulations, definitions, guidances (Kristin) FDA regulations & definitions, FDA/HHS similarities & differences, applicability (Kathy & Sandy) Reportables: Adverse Events, Unanticipated Problems Involving Risks to Subjects or Others (Darcy) HSPP/IRB Organizational & Administration International Research (Kristin, Sandy) Vulnerable Populations (Frances Richmond)

Week 2 (6/23/08)

Week 3 (6/30/08)

Week 4 (7/7/08)

Week 5 (7/14/08)

Week 6 (7/21/08)

Updated 6/19/08

1 of 2

Week 7 (7/28/08)

Revisit FDA & OHRP ICH & GCP (Kathy & Kristin or Sandy) HIPAA, COI, State Law (Marlene) *Pre-post practice test, Q&A, CIP Discussion, Test Strategies (Sandy Jean)

Week 8 (8/4/08)

Week 9 (8/11/08)

*Pre-post practice test (Sandy) TBD

Notes: We want to have people teach their expertise and don’t want to overburden anyone. The OPRS office will confirm attendance, handle logistics, etc… Course materials will be provided by OPRS: IRB Management and Function (Bankert & Amdur), Protecting Study Volunteers in

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