How to Prevent or Handle Protocol Deviations and Violations to be GCP and Regulatory Compliant? March 22, 2013

This GCP compliance training will discuss the regulatory requirements for handling protocol deviations and violations and the importance of documentation that is required. The presenter will provide specific examples and proven tips for handling instances of protocol violations.

Why Should You Attend:

Following exactly the signed and approved (IRB + PI) Protocol to the letter is the goal and mandate of all clinical research. This, in fact, is included on the FDA Form 1572.

This Webinar deals with what happens, and under what circumstances, when the protocol is not followed (PNF) and why this is of particular significance. Covered, will be how a protocol deviation with the least significant effect where there is no substantive effect on the risks to research participants, no substantial effect of the value or integrity of the data, and did not result from willful or knowing misconduct on the part of the investigator is handled.

Official Website: http://www.complianceonline.com/ecommerce/control/trainingFocus/~product_id=701760?channel=yahooevent