Good Clinical Practice 101 – A Refresher

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Good Clinical Practice 101 – A Refresher

Course Information

Course Code

CRCE110

Instruction Method

Online – login information will be emailed within 3 business days of registration.

Fee

Domestic: $150
International: $188

Length

Students can expect to dedicate 20 hours to complete the course. Continuous enrolment maximum 6 months to complete.

Instructor(s)

There is no tutor assigned to this self-study course.

Learner Outcomes

This course is designed to provide clinical research professionals with the basics of Good Clinical Practices. The course can be used to fulfill the Health Canada GCP training requirements, either as initial training or as a refresher. The content is also suitable as a primer for those interested in clinical research who want to understand the key points.

Upon successful completion of the course, the learner will be able to:

  1. Explain the history of Good Clinical Practice in clinical research.
  2. Explain the drug development process.
  3. Describe the roles and responsibilities of personnel and organizations involved in clinical trials.
  4. Explain the ethical principles governing clinical research.
  5. Describe the primary aspects of privacy and protection of personal information related to clinical research.
  6. Describe Good Documentation Practices.
  7. Discuss recruiting challenges and strategies.
  8. Describe the requirements for collecting and reporting adverse events in clinical trials.
  9. List and describe the importance of the Health Canada (Division 5) and ICH regulations relating to the conduct of clinical trials.

Evaluation Method

9 quizzes

Intended For

  • Individuals new to clinical research who need initial GCP training
  • Current clinical researchers who need GCP refresher training
  • Any learner interested in understanding the basic elements of clinical research

Text Book

None - all learning materials are provided online

Prerequisites

None

CRCE110 – Good Clinical Practice 101 – A Refresher

Registration instructions:

  1. Select button “View Available Sections and Registration”
  2. This page contains 3 boxes. Click on the “Sign In” box
  3. If you have a Self service account, sign in here. If you do not, then create an account.
  4. Select your course/section by clicking the “Add” button which will send the course to your cart.
  5. To move on to payment, click the blue “Register” button.
  6. Once payment has been processed, registration is complete.

COVID Vaccine Requirement:

Proof of full vaccination (2 doses) for all learners is required for all onsite attendance at Michener.
Fully online courses do not require proof of vaccination.

Instructions to upload proof of COVID vaccination to Self Service