Auditing Clinical Trials for Good Clinical Practice (GCP) Compliance 2016

Topics

• Differences between protocol deviations/violations/exceptions
• ICH guidelines and Good Clinical Practice (GCP)
• Most frequent audit findings
• Understanding compliance
• Responding to audit findings
• Audit preparation

Who should Attend

• CROs study team
• Clinical trial sponsors study team
• Principal Investigators, Site Managers and Study Coordinators
• Study Managers, Clinical Team Leads, CRAs
• Regulatory Compliance Associates and Managers