The GRS Good Clinical Practice (GCP) 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.
- 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 GRS GCP 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.
The GRS Good Clinical Practice (GCP) Course is recommended by:
We are currently offering our Good Clinical Practice (ICH GCP) 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.
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 account page.