Good Clinical Practices | CTDM.X411
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.
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
Professional Credit
UCSC EXTENSION Approved by the California Board of Registered Nursing, Provider Number 13114, for 30 contact hours- Save Your Seat
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What students are saying
"I would argue that your certificate program is better than most degreed programs."
— Kristina Liu, PhD. ACRP-CP/CPM
Clinical Research Coordinator, Byers Eye Institute, Stanford University
"I just want to thank you for the amazing class on the GCP research process. I enjoyed the many real life examples you provided throughout the course. I found this to be very helpful. Dr. Wallis is an excellent speaker and communicator."
— Dita Papraniku
Clinical Dietician
