Method
Flexible
Term
FALL
Units
3.0 QUARTER UNITS
Estimated Cost
$740

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.

Topics

  • 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

Syllabus Library
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