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Not All the Risks are 'Clinical' in Clinical Research
Program Code:
FR-11
Date:
Friday, October 15, 2010
Time:
1:15 PM to 2:15 PM
EST
PRESENTER
:
Douglas Borg,
MHA, ARM, CPHRM, DFASHRM, Director of Insurance,
Duke University Health System
Douglas Borg is the Director of Insurance for Duke University Health System. He has responsibility for the insurance management and loss control activities that support Dukes captive-insured program. Prior to this role, he was the Director of Risk Management for Duke University Medical Center for more than 12 years. He earned his MHA from the Medical College of Virginia in 1991. He has served in multiple roles and committees at both the state and national level. He has been twice-elected president of the NC Chapter of ASHRM, and served as ASHRM's President in 2008.
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Description
You've heard about the ethical and clinical risks associated with clinical trials, but nobody talks about the insurance and contractual aspects that could be creating hidden exposure for your organization. Do your insurance policies cover clinical research? Do you know what contracts your providers are signing? Is your organization in compliance with reserach protocols? This session will help you identify potential areas of exposure in your organization relating to research agreements, indemnification language, IRB structure, compliance, and regulatory issues. The session will also include the demonstration of an algorithm for evaluating the potential risk of a specific trial.
LEARNER OUTCOMES:
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identify exposures associated with clinical research activities
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understand how clinical research can create contractual and potentially uninsured exposures
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understand the importance of evaluating and controlling the risks of clinical trials