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About this course
To be properly governed, clinical research must be conducted according to established ethical principles, guidelines for responsible research conduct, relevant national legislation, regulations, and institutional policy.
The Regulatory Framework and Ethics in Clinical Trials short course provides students the knowledge essential for understanding the Therapeutic Goods Administration (TGA) requirements for conducting clinical trials in Australia. You will also learn the role of the National Health and Medical Research Council (NHMRC) and difference between ethics and governance and their importance in the clinical trial context.
What you’ll learn
You will learn the following topics in this short course:
MODULE NAME |
Ethical conduct in human research |
How to obtain ethics approval for a clinical trial |
Research governance |
Site specific assessment |
Protocol deviations/violations and reporting requirements |
Data Protection in Clinical Trials |
Data Protection Regulations |
Insurance and Indemnity in Clinical Trials |
Final Quiz (1 hour) |
Who is this course for?
This program is ideal for individuals interested in a career in clinical research, specifically as a clinical trial ethics or safety coordinator.
Requirements
Nil
Duration
The course, quizzes and supplemental materials are designed to be completed in approximately 50 hours at your own pace. You have up to 365 days from purchase date to complete the course.
Course Delivery
The course is delivered online through our Member’s Portal.
Certification
- To obtain the completion certificate for Regulatory Framework and Ethics in Clinical Trials course, you will need a score of ≥ 80% to pass all your assessments.
- You can retake a single module mini quiz as many time as you wish
- You are allowed 2 attempts to pass the final quiz. Failing both attempts requires you to contact us at info@clueoclinical.com.
If you meet these criteria, your certificate of successful completion will be emailed to you within 48 hours after you finish the course.
Course Fee
$1,214 inc. GST