BIMO: Sponsor/Monitor Responsibilities

This course focuses on the responsibilities of sponsors and monitors of clinical research involving unapproved test articles under the jurisdiction of FDA. Topics in this course include: Responsibilities, Applicable Regulations, Compliance Program 7348.810, Strategy, Inspectional Elements, Additional Elements, Potential Outcomes, and Regulatory Actions. After completing this course, learners will be able to recognize the roles and responsibilities of both sponsors and monitors in conducting clinical trials and use that knowledge to conduct inspections successfully in the BIMO program.