Oversight of Clinical Monitoring: Trends and Strategies

Part 2:
The Details of Site Monitoring
•Define ICH and FDA requirements for site monitoring
•Regulatory requirements for transferring contractual obligations
•Identify Sponsor responsibilities for oversight
•Introduce “Quality Oversight” programs
•Approaches to monitoring – Centralized and On-Site
•Metrics Champion Consortium – RBM Survey
•Audit/inspection observations and findings regarding site monitoring

Questions/Answers