Clinical Research Operations

Drug Development: Role of the FDA and Sponsor

Understanding the history of the FDA, its role and the Sponsor’s role in the drug development process will provide research team members with a better understanding of how their roles fit into the process. For those investigators who also serve as a sponsor, it is important to understand what that entails and for the research team, what other responsibilities might be required of them. The five required parts of this module are from the “Introduction to the Principles and Practice of Clinical Research” course regarding FDA Product Regulations from February 2023. There are seven recommended videos.  

Once you have completed the required parts, please complete the evaluation after which you will be directed to a certificate of completion for your education records.

Module Objectives

At the conclusion of this module, learners will be able to:

• Describe the historical perspective of the FDA's regulations governing drug development.
• Explain the drug development and review process in the United States.
• Describe the roles of the Sponsor and investigator in the conduct of clinical trials.
• Identify the mechanisms in place for monitoring the safety of drugs and biologics.
• Explain the importance of study data standards throughout drug development.