How to Prevent or Handle Protocol Deviations and Violations to be GCP and Regulatory Compliant - Webinar By GlobalCompliancePanel

4 October 2011, Wilmington, United States

Introduction

How to know when the protocol is not followed (PNF)?
What is the difference between a protocol deviation and a violation?
Importance of the "Protocol" in the number of deviations occurring
How to ensure that the protocol will be followed exactly?
What is in the Regs about following the protocol?
When may the Investigator make changes in the protocol?
What are the causes of Protocol Deviations and Violations?
How are Protocol Deviations managed?
Examples of Protocol Violations and Deviations