Good Clinical Practice (ICH GCP (R3)) Online Training Course

The Good Clinical Practice (ICH GCP (R3)) Online Training Course is designed to prepare research professionals for the conduct of clinical trials. It covers the latest version of the ICH GCP guideline (ICH E6(R3)), including the principles of ICH GCP and the roles and responsibilities of the investigator. The course and certificate are compliant with the TransCelerate Mutual Recognition (MR) Program for ICH E6 Good Clinical Practice (GCP) Training, enabling recognition of GCP certification within the clinical research industry.

Course enrolment includes access to a complete (72 page) downloadable study guide and additional resources. Scroll down for more information.

Are you interested in progressing your clinical trials knowledge even further? Have a look at our Research Fundamentals Training Course.

$20.00 Includes GST

! Note on bulk purchasing & purchasing for others

Bulk Purchases:

To purchase our Good Clinical Practice (ICH GCP (R3)) Course in bulk, please send an email to reception@genesisresearchservices.com with the subject “Bulk Course Purchase” or call us on +61 (0)2 4985 1860.

Purchasing for Others:

If you are purchasing for someone else, please log out before adding the course to your cart. On the checkout page, under billing details, please enter the name and email address of the user who will be completing the course. Alternatively, create an account for the person you are purchasing for and complete checkout under that account.

Good Clinical Practice (ICH GCP (R3)) Online Training Course
Category

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:

  1. Overview of Good Clinical Practice
  2. What’s New in ICH E6(R3)?
  3. The Principles of ICH GCP (R3)
  4. Clinical Trial Roles – An Overview
  5. Roles & Responsibilities
    1. Sponsor
    2. Investigator
    3. Ethics Committee
  6. Informed Consent of Trial Participants
  7. Trial Records & Data Governance
  8. 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 Purchases

If you would like to purchase our Good Clinical Practice (ICH GCP (R3)) Online Training Course in bulk, please send an email to reception@genesisresearchservices.com with the subject “Bulk Course Purchase” or call us on +61 (0)2 4985 1860 to enquire. Please state the number of user enrolments you would like to purchase in bulk. 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

 


Registration Instructions

To register for the course, add the course product to your cart, view your cart, and proceed to the checkout page. If you already have an account with us, please click on the returning customer link to login, enter your payment details, and place your order. If you are new to our website, you will be asked to enter an account username and create a password on the checkout page. Your account will be automatically created and activated after you have completed checkout.

Once you have placed your order, you will be able to login and access the course from your Student Account.

Please view our Frequently Asked Questions for further instructions.

Purchasing on behalf of others

If purchasing a course on behalf of someone else, please ensure you are logged out of your own account before adding the course to your cart. When filling out the Billing details section on the checkout page, please enter the first name, last name, and email address of the person who will be completing the course as this is the name that will appear on the course certificate of completion. Users can edit their first and last name later if needed via the My Account page.

 


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.