Principles of Clinical Research I

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Principles of Clinical Research I

Course Information

Course Code

CRCR130

Instruction Method

Online – login information will be emailed on the course start date

Fee

Domestic: $952 International: $1190

Length

12 weeks – 4.8 CEU

Instructor(s)

Debbie Warner, RN, CCRC

Learner Outcomes

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

  1. Explain the drug development process
  2. Describe the Canadian drug review process
  3. Describe the elements of a clinical trial
  4. Describe the roles and responsibilities of personnel and organizations involved in clinical trials.
  5. Understand and use the terminology associated with clinical research trials
  6. List and describe the importance of the regulations relating to the conduct of clinical trials (ICH, Health Canada (Division 5), and FDA).
  7. Explain the ethical principles governing clinical research
  8. Describe Good Documentation Practices
  9. Understand Electronic Data Capture (EDC) Principles
  10. Describe the primary aspects of privacy and protection of personal information as related to clinical research.
  11. Discuss recruiting challenges and strategies.
  12. Describe the requirements for collecting and reporting of Adverse Events in clinical trials

Course Objectives

The learner will begin his/her development as a member of the clinical research team through the study of clinical research Good Clinical Practices and the development of practical skills in clinical trials. During this process, students will acquire the core skills required to become a part of the clinical research team. The course will introduce the learner to the role of clinical trials and research in the health care sector and in industry. The phases and elements of clinical trials will be considered and current issues relating to clinical research will be discussed.

Evaluation Method

Individual assignments, group case study, test, participation

Intended For

Healthcare professionals interested in clinical research


Note:

Course registration will close once maximum number of students enroll. Register as soon as you can!

Note: If you are currently working in Clinical Research you may be eligible for a Prior Learning Assessment, for the course Principles of Clinical Research I- CRCR130. Please contact ce@michener.ca for more information. 

Text Book

Not required.

Certificate Program

Clinical Research Program

Prerequisites

None

Topics Covered

– History of Clinical Research

– Roles and responsibilities of key personnel involved in clinical research

– Role of clinical research in the development and marketing of therapeutic interventions

– Elements of a clinical trial

– Phases and types of clinical trials

– Terminology associated with clinical trials

– Importance of regulations relating to the conduct of clinical trials [ICH, FDA, TPD]

– Good Clinical Practices Guidelines

– Recruiting study subjects

– Requirements for the reporting of Adverse Events

Principles of Clinical Research I (CRCR130) is part of the Clinical Research Program.  This course is for healthcare professionals interested in clinical research that need to develop the basic skills for a clinical trial environment.

 

Registration instructions:

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  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