OFFICE
OF
RESEARCH COMPLIANCE
presents
RESEARCH COMPLIANCE MATTERS
RESEARCH COMPLIANCE WORKSHOPS
Fall 2007
WORKSHOP
“Device Advice: Common Pitfalls for Investigators in Medical Device
Clinical Studies”
Speaker:
Norma Epley, M.P.H.
Asst. Director, Division of Research Integrity & Compliance,
USF Human Research Protections Program
As a result of participation in this activity, participants will:
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


Have a working understanding of applicable medical device regulations
Understand the IRB’s role from the beginning of the device development project
Evaluate significant versus non-significant risk and custom versus non-custom
devices
Understand considerations in the emergency, compassionate and humanitarian use
of devices
Friday, November 30, 2007
Children’s Medical Service Building (CMS) 3048
(Directions Below)
Lecture & Workshop 11:45 to 1 p.m.
LUNCH PROVIDED
LIMITED PARTICIPATION —CALL TODAY TO RESERVE YOUR PLACE:
CHARMAINE DISIMILE 974-7715
http://health.usf.edu/research/compliance/Training+Workshops+and+Seminars.htm