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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

Applies Towards the Following Certificates or Series

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Enroll now - Select a section

Section Title
Human Subjects Protection
Type
Discussion
Days
W
Time
6:00PM to 9:00PM
Dates
Oct 07, 2020
Type
Discussion
Days
W
Time
6:00PM to 9:00PM
Dates
Oct 21, 2020
Schedule and Location
Contact Hours
6.0
Course Fee(s)
Non-Credit Course Fee non-credit $750.00
Instructors
  • Molly Adamek
  • Kate Bryant-Greenwood
  • Stacy Mercado
  • Jenai Umetsu
Section Notes

Certificate program is online via Zoom.

Email CRPcertificate@cc.hawaii.edu for program-related questions. For registration assistance, please contact hagal@hawaii.edu.

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