Clinical research is governed by a set of broad regulatory requirements, industry standards and recommendations. Interpreting and implementing these “best practice” standards presents a challenge for all the stakeholders involved in human research. This course explores the framework and principles of Good Clinical Practice (GCP) as it relates to the roles and responsibilities of various stakeholders like the FDA, Investigator, Sponsor, IRB and the study subject. Through lectures, homework, quizzes and the final exam, you will gain knowledge of regulations (federal, state and local) and learn to apply the principles of GCP.

Skills Needed

• To be successful in this class all students should have working knowledge of Google’s G Suite or Microsoft Office, proper email etiquette, and essential understanding of Canvas.

Learning Outcomes

At the conclusion of the course, you should be able to

• Describe the fundamental principles of Good Clinical Practices (GCP)
• Discuss the roles and responsibilities of key players and stakeholders as it relates to Human Subject Protection
• Explain the principles of GCP to answer questions arising from everyday clinical research situations
• Identify various regulations that directly or indirectly impact GCP

Topics Include

• Regulations, Standards and Principles
• Sponsors and Protocol
• Institutional Review Board and HIPAA
• Study Documentation, Source Data and Test Article
• Quality Management (Monitoring)
• Patient Recruitment, Financial Disclosure and Compliance

Notes

Professional Credit: CA BRN/LVN Credit--Provider #CEP13114.