Method
Flexible
Term
SPRING
Units
3.0 QUARTER UNITS
Estimated Cost
$845

Skills you will gain

  • Good Clinical Practices (GCP) Principles: Understand the foundational principles that govern clinical research.
  • Stakeholder Roles: Learn the roles and responsibilities of key stakeholders like the FDA, Investigator, Sponsor, IRB, and study subjects.
  • Human Subject Protection: Apply GCP principles to ensure ethical standards in protecting human subjects.
  • Regulatory Compliance: Identify and understand the regulations affecting GCP practices at federal, state, and local levels.
  • Practical GCP Application: Address everyday clinical research challenges by applying GCP principles effectively.

Course Description


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

 

Additional Information

AI* - This course includes topics on how generative AI is and will be used across GCP, including Quality Management and ongoing Drug Development. The course will also explore how AI can be used to deliver faster trials - and how it can support teams, instead of eliminate them. 

Syllabus Library
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This course applies to these programs:

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