Good Clinical Practice - ICH GCP Guidelines - Monitor's Responsibilities 2023/2024

Good Clinical Practice - ICH GCP Guidelines - Monitor's ResponsibilitiesWhat is the overall purpose of monitoring? - correct answer To verify - the rights and well-being of human subjects are protected - reported trial data are accurate, complete and verifiable from source documents - the study is conducted in compliance with the study protocol, the GCP guidelines and applicable regulations Who appoints the monitor? - correct answer The Sponsor What does the monitor verify in regards to the investigator/site? - correct answer - Investigator qualifications - Appropriate product storage, handling and accountability - Investigator compliance with the protocol, regulations and GCP guidelines What should written reports from each monitoring visit include? - correct answer - The investigator's name and site location - Date of visit - Name of monitor - Site personnel contacted - Summary of what information was reviewed - Significant findings and corrective actions The monitor acts as the main line of communication between who? - correct answer The sponsor and the investigator