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.
- Introduction to Clinical Trials
- Good Clinical Practice – An Overview
- The Australian Regulatory Environment
- Roles and Responsibilities
- Investigator Qualifications and Agreements
- Medical Care of Trial Participants
- Communication with HREC
- Compliance with Protocol
- Investigational Products
- Randomization Procedures and Unblinding
- Informed Consent of Trial Participants
- Records and Reports
- Progress Reporting and Final Reports
- Safety Reporting
- Premature Termination or Suspension of Trial
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:
We are currently offering our Good Clinical Practice (ICH GCP) Training Course for AUD $10 (inc. GST).
- 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.
If you would like to purchase our Good Clinical Practice (ICH GCP) Training Course in bulk, please send an email to email@example.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
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, when filling out the Billing details section, please enter the 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.