World of Compliance Module

Learning Objectives

Upon completion of the comprehensive Scientific Investigations unit, you will be able to:

• Discuss the requirements for monitoring bioresearch such that human subjects' rights and welfare are protected
• List the relevant regulations related to bioresearch with human subjects
• Describe the sponsor and clinical investigator responsibilities
• List the types of inspections and classification of findings as related to bioresearch with human subjects
• Describe the regulation of clinical trials outside the U.S.

Now that you understand the objectives we are trying to achieve, let's begin this unit.