Description
The Genesis Research Services Good Clinical Practice (ICH GCP (R3)) Online Training Course is designed to prepare research professionals for the ethical conduct of clinical trials.
The ICH Good Clinical Practice (GCP) Guideline (ICH E6(R3)) is a unified, globally recognised, ethical, scientific, and quality standard for conducting clinical trials. It sets the responsibilities and expectations of sponsors, investigators, and other professionals involved in designing, conducting, monitoring, recording, and reporting of clinical trials. Compliance with GCP helps to ensure that the rights, safety, and well-being of participants are protected, and that clinical trial data are high quality and the results are reliable.
This course meets the Minimum Criteria for ICH GCP Investigator Site Personnel Training (based upon ICH E6(R3)) as identified by TransCelerate BioPharma, enabling mutual recognition of GCP training among trial sponsors.
This is a self-paced online course consisting of five (5) lessons, mini quizzes, and a final assessment quiz. The course takes approximately two to four (2 – 4) hours to complete.
A personalised GCP training certificate will be available for download upon successful completion of all course lessons and the final assessment quiz.
Course Content
Key topics covered in this course include:
- Overview of Good Clinical Practice
- What’s New in ICH E6(R3)?
- The Principles of ICH GCP (R3)
- Clinical Trial Roles – An Overview
- Roles & Responsibilities
- Sponsor
- Investigator
- Ethics Committee
- Informed Consent of Trial Participants
- Trial Records & Data Governance
- Trial Conduct & Management
Supplementary content (optional, not assessed):
- Clinical Trial Regulation in Australia (including the roles of the TGA, NHMRC, and HRECs, and application of ICH GCP (R3) in Australia).
Course Recognition
The Genesis Research Services Good Clinical Practice (ICH GCP (R3)) Online Training Course and certificate are compliant with the Mutual Recognition (MR) Program for ICH E6 Good Clinical Practice (GCP) Training, as developed by TransCelerate BioPharma through the Site Qualification and Training (SQT) Initiative. This ensures professional recognition of GCP training and certification within the clinical research industry.
Pricing
We are currently offering our Good Clinical Practice (ICH GCP (R3)) Online Training Course for AUD $20 (inc. GST).
Inclusions
- Immediate course access.
- Complete downloadable study guide (72 pages).
- Personalised GCP training certificate (issued upon successful completion of the final assessment quiz).
- Additional downloadable resources:
- GCP Principles Summary Sheet (2 pages).
- References and Resources (2 pages).
- Clinical Trial Regulation in Australia (14 pages, optional, not assessed).
Bulk Purchase Discounts
Discounts are available for bulk purchases of 10 or more user enrolments:
- 10 or more: 10% off
- 20 or more: 15% off
- 30 or more: 20% off
Instructions for Bulk Purchasing
To purchase this course in bulk, enter the number of staff or students you would like to purchase the course for (quantity) and click the “Add to cart” button. The quantity may be updated on the cart page. On the checkout page, enter your billing details, payment details, and place your order.
You will receive an order confirmation email. Please check your junk or spam folder if you do not receive this email. This email will show the quantity purchased, followed by a list of randomly generated usernames and passwords for you to distribute to your staff or students.
Each user will need to login to the Genesis website and update their personal details via the My Account Details page. It is important that users update their first name and last name as this is what will appear on their certificate of completion. Users should also update their email address and create a new password.
Users will have immediate access to the course via their Student Account.
Please view our Frequently Asked Questions for more information.
Terms & Conditions
Use of any Genesis Research Services Course is subject to the Online Education Terms and Conditions, which set out our Refund Policy, Cancellation / Variation details, Disclaimers and more. Please read these terms and conditions carefully prior to purchasing a course.
