This White Paper Showcase will interpret the FDA's 2011 "Draft Guidance for Industry Oversight of Clinical Investigation-A Risk-based Approach" and highlight the implications for organizations conducting clinical research. It will also explore alternative methods to monitoring and detail how sponsors and investigative sites can incorporate remote monitoring into their future trial design and monitoring plans.

Brought to you by Cape Cod Clinical Reserach, Inc.

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Learning Objectives:
Describe the FDA's 2011 "Draft Guidance for Industry Oversight of Clinical Investigations—A Risk-Based Approach"
Identify the implications and pros and cons of alternate methods to monitoring, such as centralized and remote monitoring
Discuss how to incorporate remote monitoring into trial design and monitoring plans.