GCP/ICH Obligations of Sponsors and Monitors

This course describes sponsor and monitor requirements and responsibilities for the conduct of clinical trials in support of new drug and biologics applications. Topics in this course include: Sponsor’s Role, Research Team, Investigators, Prestudy Site Visit (PSV), Other Visits, and Monitoring Activities. After completing this course, learners will be able to recognize the roles and responsibilities of sponsors and monitors during clinical trials. 

After this course learners will be able to recognize the roles and responsibilities of sponsors and monitors in clinical trials. identify regulatory requirements, the types of personnel selected to run the trial, elements of sponsor-investigator interaction, types of site and monitoring visits, and the extent of the regulations that burden the sponsor’s monitoring responsibilities in the process of new product development.