Program Overview

Good Clinical Practice: A Refresher

Overview

This refresher course defines the minimum criteria for Good Clinical Practice (GCP) training of investigators and site personnel (based upon International Council of Harmonisation (ICH) E6 R2). To satisfy these minimum criteria, it includes an overview of current GCP, the principles of ICH-GCP, and investigator responsibilities, and is accredited by TransCelerate.

Course Content

Topics covered include:

• Current ICH GCP principles
• Current Australian regulatory requirements
• Audits and breaches
• Documentation and source data
• Ethical considerations
• Researcher roles and responsibilities
• Informed consent
• Protocol adherence, data management, and safety reporting.

Key Facts

• Course category: For Organisations - Scheduled Courses, Digital Health and Practice Excellence
• Options:
  • Option 1: Self-paced, start anytime, Workshop: Thursday 19th March 2026, Online (On demand)
  • Option 2: Self-paced, start anytime, Workshop: Tuesday 19th May 2026, Online (On demand)
  • Option 3: Self-paced, start anytime, Workshop: Wednesday 22nd July 2026, Online (On demand)
  • Option 4: Self-paced, start anytime, Workshop: Thursday 17th September 2026, Online (On demand)
  • Option 5: Self-paced, start anytime, Workshop: Tuesday 17th November 2026, Online (On demand)
• Duration: 2 hours
• Group Bookings: Enquire now
• Prerequisite/s: Good Clinical Practice
• Certification: Certificate of Achievement

Why this Course?

Accredited by TransCelerate BioPharma Inc, this course provides certification for researchers involved in clinical trials, meeting training requirements for many universities and institutions. It aligns with ICH-GCP principles, Australian regulations, and best practices for ethical, high-quality research and clinical trials with human participants.

Your Study Experience

The course is 2 hours in duration, with multiple-choice quizzes for assessment. Upon successful completion of the course, you will receive a certificate of completion valid for three years, after which you will be required to complete another Good Clinical Refresher course to maintain certification validity. The assessment will comprise a multiple-choice quiz, requiring a minimum score of 80% to pass.

You'll Learn

• To review and update your knowledge of Good Clinical Practice principles and policies in relation to Australia regulations
• Update your Study Conduct and Risk Management Skills consistent with ICH-GCP requirements
• Update your application of ICH-GCP principles.

Related Courses

Good Clinical Practice: An Introduction

• Duration: 3 hours
• Mode: Online
• Description: Delivering the essentials of Good Clinical Practice, this accredited course equips you to conduct ethical, high-quality clinical trials.
• Price: $495.00