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, Records and Documentation, Research Team, Investigator Oversight, Pre-Trial Monitoring Visit, Other Visits, and Monitor Activities. After completing this course, learners will be able to recognize the roles and responsibilities of sponsors and monitors during clinical trials.
