Method
Flexible
Term
SPRING
Units
3.0 QUARTER UNITS
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

°®¶¹´«Ã½ EXTENSION Approved by the California Board of Registered Nursing, Provider Number 13114, for 30 contact hours

Jeaneen C Wallis
Jeaneen Wallis
Apr. 6 - Jun. 22, Monday, 6:00pm - 9:00pm
  • Flexible Attend in person or via Zoom at scheduled times.
CTDM.X411.(18)
Schedule
Date Start Time End Time Meeting Type Location
Mon, 04-06-2026 6:00pm 9:00pm Flexible SANTA CLARA / REMOTE
Mon, 04-13-2026 6:00pm 9:00pm Flexible SANTA CLARA / REMOTE
Mon, 04-20-2026 6:00pm 9:00pm Flexible SANTA CLARA / REMOTE
Mon, 04-27-2026 6:00pm 9:00pm Flexible SANTA CLARA / REMOTE
Mon, 05-04-2026 6:00pm 9:00pm Flexible SANTA CLARA / REMOTE
Mon, 05-11-2026 6:00pm 9:00pm Flexible SANTA CLARA / REMOTE
Mon, 06-01-2026 6:00pm 9:00pm Flexible SANTA CLARA / REMOTE
Mon, 06-08-2026 6:00pm 9:00pm Flexible SANTA CLARA / REMOTE
Mon, 06-15-2026 6:00pm 9:00pm Flexible SANTA CLARA / REMOTE
Mon, 06-22-2026 6:00pm 9:00pm Flexible SANTA CLARA / REMOTE
 

This class meets simultaneously in a classroom and remotely via Zoom. Students are expected to attend and participate in the course, either in-person or remotely, during the days and times that are specified on the course schedule. Students attending remotely are also strongly encouraged to have their cameras on to get the most out of the remote learning experience. Students attending the class in-person are expected to bring a laptop to each class meeting.

No meetings on 5/18/26 and 5/25/26. To see all meeting dates, click "Full Schedule" below.

You will be granted access in Canvas to your course site and course materials approximately 24 hours prior to the published start date of the course.

This course applies to these programs:

Demo