Welcome

Welcome to the Investigator and Site Personnel Good Clinical Practice (ICH GCP) online training program.

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 enable the mutual recognition of GCP training within the Australian clinical research industry. To satisfy these Minimum Criteria, the training includes GCP overview, the principles of ICH-GCP and investigator responsibilities.

Instructions

To begin a unit, click the unit title. You will be taken to a content page, which you should read through carefully. Some units contain short videos that we recommend you take the time to watch. External links appear as bold text and should automatically open in a new tab.

You can view and complete the course units in any order, however, we recommend that you progress through the units in the default order. At the end of each unit page, you will need to click the "Mark as Completed" button in order to confirm your progress.

You can revisit completed units at any time by returning to this page via the GRS site menu at the top of the page, or by using the Course Progress widget located on the right side of each unit page. Click on the plus (+) sign to expand a module and view the complete list of units. Completed units will be coloured green. To move onto the next unit or revisit the previous unit, click the "Next Unit" or "Previous Unit" buttons located at the bottom of the unit page.

Unit 14 (Module 2) is the GCP assessment quiz. You will need to correctly answer at least 16 of the 20 questions (a score of at least 80%) to pass the course.

Certification

GRS training providers will issue a GCP training certificate upon successful completion of the course. The course and certificate are compliant with the TransCelerate Site Qualification and Training (SQT) Initiative, reflecting professional recognition for ICH E6 Good Clinical Practice (GCP) Training targeted to investigator site personnel.

 

Module 1 Investigator and Site Personnel Good Clinical Practice - Introduction
Unit 1 Introduction to Clinical Trials
Unit 2 Good Clinical Practice in Australia – An Overview
Unit 3 The Australian Regulatory Environment
Unit 4 Roles and Responsibilities
Module 2 Investigator and Site Personnel Good Clinical Practice - The Principles of ICH GCP
Unit 1 Investigator Qualifications and Agreements
Unit 2 Resourcing
Unit 3 Medical Care of Trial Participants
Unit 4 Communication with HREC
Unit 5 Compliance with Protocol
Unit 6 Investigational Products
Unit 7 Randomization Procedures and Unblinding
Unit 8 Informed Consent of Trial Participants
Unit 9 Records and Reports
Unit 10 Progress Reporting / Final Reports
Unit 11 Safety Reporting
Unit 12 Premature Termination or Suspension of Trial
Unit 13 References, Links and Further Reading
Unit 14 GCP Assessment
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