Introduction to Good Clinical Practice (GCP) 2025

Introduction to GCP is TransCelerate-endorsed and facilitated by Dr Emma Kirk, Ms Charmain Strauss, Ms Belinda Fazekas, Dr Rayan Sala Moussa, Ms Jessie Hao and Prof Meera Agar who are TransCelerate-certified.

We invite you to participate in this dynamic and interactive training if you are a UTS staff or student currently involved with, or planning to be involved with, clinical trials or clinical studies which prospectively assigns human participants or groups of humans to one or more health-related interventions to evaluate the effects on health outcomes. All members of the research team (investigators, clinical trials staff, and site investigators) must hold appropriate and current training in Good Clinical Practice (GCP) as provided by a TransCelerate-approved provider.

GCP training will provide you with a foundation to help you carry out your roles and responsibilities in the research process with confidence. The content and approach of the day is focused on the practical aspects of applying the quality standards that are integrated into GCP to ensure that the rights, safety and well-being of research participants are always protected.

IMPORTANT: 

In order to successfully complete GCP, you are required to attend all five sessions on the day. If you can only partially attend the training, you will need to wait until the next GCP training is available to complete any missing incomplete/sessions before we issue a certificate. 

The online training will cover:

• the importance of the interwoven laws, frameworks and guidelines which govern the set up and conduct of clinical research
• the roles and responsibilities of different individuals and organisations in clinical research
• regulatory applications required before clinical research can be started in Australia
• essential documents and the purpose of maintaining a trial master file
• informed consent (and equivalent processes where appropriate) and the roles and responsibilities of those involved in this process
• correctly and accurately complete case report forms and other relevant documentation and understand the process for data query resolution
• correct reporting requirements that ensure participant/patient safety 

Workshop Program: