This class provides a high level overview of general research compliance expectations when engaging in human subject research with a particular emphasis on interventional clinical trials. This includes the requirements for study activation, study management, as well as monitoring and data and safety monitoring oversight. Engaging in clinical research activities takes a village of people including the medical care team, coordination, regulatory, finance, investigational pharmacy, specimen processing, etc. Ensuring that clinical research activities are carried out compliantly with the highest ethical and regulatory standards and regulations protects our patients and our communities.

At the conclusion of this class, you should be able to:

• Understand the ethical and regulatory expectations for opening a new clinical trial
• Identify who is ultimately responsible for ensuring protocol compliance at a site level
• Describe the informed consent process
• Produce examples of types of reportable events
• Explain how we ensure data integrity and source documentation in clinical trials                
• Summarize why data and safety monitoring oversight is important and the difference between quality and compliance