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戻る Agenda
Part 2:The Details of Site Monitoring
Session Chair(s)
Lynn King, MHA
Chief Operating Officer
M3 Wake Research, Inc, United States
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