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

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Why Should You Attend: Protocol Deviations and Violations are one of the most common problems identified by FDA Investigators and is a main reason for the rejection of clinical data from a particular site or even a study. Forewarned is forearmed.

Areas Covered in the Session:
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
Who Will Benefit:
Principal Investigators / Sub-investigators.
Clinical Research Scientists (PKs, Biostatisticians,)
Safety Nurses
Clinical Research Associates (CRAs) and Coordinators (CRCs)
Recruiting staff
QA / QC auditors and staff.
Clinical Research Data managers