How to Prevent or Handle Protocol Deviations and Violations to be GCP and Regulatory Compliant 2013

Topics

• What are Protocol "Deviation" and other terms / categories
• The Primacy of the study Protocol
• The Regulatory requirements for handling protocol deviations and violations
• The many cause of protocol deviations
• How to define and handle instances of PNF
• The importance of documentation of protocol deviations as well as violations
• What is the basis of the difference between a "Deviation" and a "Violation"
• What is the reason different IRBs define deviations and violations differently

Who should Attend

• Clinical Research Scientists (PKs, Biostatisticians,)
• Principal Investigators / Sub-investigators
• Clinical Research Associates (CRAs) and Coordinators (CRCs)
• Safety Nurses
• QA / QC auditors and staff
• Recruiting staff
• Clinical Research Data managers