Course Description

This critical module provides participants an understanding of the regulations that protect human subjects involved in research. Attendees will gain a knowledge of current regulatory and compliance information. In addition, all participants will complete national CITI training which is a requirement for individuals entering a career in clinical research.

Course Outline

Topics to include:

  1. CITI
  2. Office for Human Research Protection Videos
  3. Participant Protection
  4. Good Clinical Practice
  5. Compliance

Learner Outcomes

  1. Participant Protection
  • Gain knowledge on the historical development and importance of human subject protections and ethical issues associated with human subjects research
  1. Good Clinical Practice (GCP)
  • Understand and apply GCPs in the research process
  • Identify the roles and responsibilities of sponsors, monitors, and investigators in conducting clinical trials using the principles of GCP
  • Identify the legal and regulatory responsibilities, liabilities, and accountabilities that are involved in the conduct of clinical trials.
  1. Compliance and CITI Review
  • Gain knowledge on the current regulatory and guidance information


"An exemplary program that allows you to dip your feet into the world of Clinical Research. With truly passionate providers to guide and mentor you, this program is fit for all who are wanting to find the confidence to take their career to the next level."~Cheyenne Tashombe, Hawaii Pacific Neuroscience

Applies Towards the Following Certificates or Series

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