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What is ICH E6(R3)? Guideline for Good Clinical Practice, V3, adopted
06Jan25
Two types of monitoring 1. Investigator Site Monitoring
2. Centralized Monitoring
Centralized Monitoring Evaluation of accumulated data; can help identify
systemic or site-specific issues
Investigator Site Monitoring Monitoring clinical trial activities at the investigator
sites; may be on-site or remote
4 Monitoring Activities 1. Communication with parties conducting the trial
2. Investigator site selection, initiation,
management, and close-out
3. Monitoring of investigational product
management
4. Monitoring of clinical trial data