Defining and Managing Protocol Deviation/Violation/Exception 2016

Topics

• Differences between protocol deviations/violations/exceptions
• ICH guidelines and Good Clinical Practice (GCP)
• Most frequent audit findings
• Understanding compliance
• Developing a CAPA plan
• Finding protocol deviations/violations

Who should Attend

• CROs study team
• Clinical trial sponsors study team
• Principal investigators, site managers and study coordinators
• Study managers, Clinical team leads, CRAs
• New Principal Investigators
• New Clinical Research Coordinators (1-2 years)
• Regulatory Compliance Associates and Managers