Good Clinical Practice (ICH GCP) Training Course (Bulk Purchase)

The Good Clinical Practice (ICH GCP) Training Course is designed to prepare investigators and research staff for the conduct of clinical trials with human participants. It provides an overview of GCP, the principles of ICH GCP, and investigator responsibilities. The course and certificate are compliant with the Mutual Recognition (MR) Program for ICH E6 (R2) Good Clinical Practice (GCP) Training developed by TransCelerate, enabling recognition of GCP certification within the clinical research industry.

Course enrolment includes access to a complete (71 page) downloadable study guide.

Please read the instructions below before purchasing this course in bulk.

$10.00

Good Clinical Practice (ICH GCP) Training Course (Bulk Purchase)

Category

Description

The Genesis Research Services Good Clinical Practice (ICH GCP) Training Course is designed to prepare investigators and research staff for the conduct of clinical trials with human participants.

The ICH Good Clinical Practice (GCP) Guideline (ICH E6 R2) is a unified, globally recognised, ethical, scientific, and quality standard for conducting clinical trials. It sets the responsibilities and expectations of sponsors, investigators, and all other professionals involved in designing, conducting, monitoring, recording, and reporting of clinical trials. Complying with the guideline helps to ensure that the rights, safety, and well-being of participants are protected, and that the trial data and results are reliable.

This course satisfies the Minimum Criteria for Good Clinical Practice (GCP) training of investigators and site personnel (based upon ICH E6 R2) as defined by TransCelerate. To satisfy these criteria, the course includes an overview of GCP, the principles of ICH GCP, and investigator responsibilities. Additionally, our course provides an overview of the Australian regulatory environment, and the roles and responsibilities of the sponsor, contract research organisation, and clinical trial monitor.

This is an online, self-paced course consisting of 2 lessons and a final assessment quiz. The course covers a total of 16 learning objectives (topics) and takes approximately 2 – 4 hours to complete.

Access to a complete (71 page) downloadable study guide is provided to course users.

A personalised GCP training certificate will be available for download upon successful completion of the course lessons and assessment quiz.

Good Clinical Practice (ICH GCP) Training Course (Bulk Purchase) -

Learning Objectives

  1. Introduction to Clinical Trials
  2. Good Clinical Practice – An Overview
  3. The Australian Regulatory Environment
  4. Roles and Responsibilities
  5. Investigator Qualifications and Agreements
  6. Resourcing
  7. Medical Care of Trial Participants
  8. Communication with HREC
  9. Compliance with Protocol
  10. Investigational Products
  11. Randomization Procedures and Unblinding
  12. Informed Consent of Trial Participants
  13. Records and Reports
  14. Progress Reporting and Final Reports
  15. Safety Reporting
  16. Premature Termination or Suspension of Trial

Course Recognition

The Genesis Research Services Good Clinical Practice (ICH GCP) Training Course and certificate are compliant with the Mutual Recognition (MR) Program for ICH E6 (R2) Good Clinical Practice (GCP) Training developed by the TransCelerate Site Qualification and Training (SQT) Initiative. This enables professional recognition of GCP training and certification within the clinical research industry. Read more about GCP Mutual Recognition here.

Our Good Clinical Practice (ICH GCP) Training Course is recommended by:

NSW Health - Newcastle Research Institute - Genesis Research Services

Pricing

We are currently offering our Good Clinical Practice (ICH GCP) Training Course for AUD $10 (inc. GST).

This includes:

  • Immediate course access
  • A complete (71 page) downloadable study guide
  • A personalised, compliant GCP training certificate.

This small fee allows us to cover the increased administrative and running costs of offering this popular training course.

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.