Good Clinical Practice (ICH GCP) Training Course

Description

The Good Clinical Practice (ICH GCP) Training Course is designed to prepare both investigators and research staff for the conduct of clinical trials with human participants. The intent of this training program is to define the Minimum Criteria for Good Clinical Practice (GCP) training of investigators and site personnel (based upon ICH E6 R2). To satisfy these Minimum Criteria, the training includes an overview of GCP, the principles of ICH GCP, and investigator responsibilities.

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.

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 within the clinical research industry. Read more about GCP Mutual Recognition here.

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

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.

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.

Note on bulk purchasing and purchasing on behalf of others

If you would like to purchase our Good Clinical Practice (ICH GCP) 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.

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.