Clinical Trial Governance

Support is available for all aspects of clinical trial conduct, including:

Starting a new trial to be sponsored by the University
For staff considering conducting a clinical trial to be sponsored by the University, please contact Dr Vera Terry for assistance. A formal Risk Assessment will need to be arranged, and Dr Vera Terry will help you provide the required documentation.

Clinical Trial Notification (CTN) Changes Effective 1st July 2015
As of the 1st July 2015, a new online form is now available for the clinical trial notification (CTN) scheme. The paper-based notification form will no longer be available, as there are some differences in the required information for the new online form. Any paper based forms the TGA receives after the 1st of July will also need to be submitted online.Please contact the Clinical Trial Governance Manager on

Online Applied Good Clinical Practice (GCP) Training for Researchers

Clinical Trial Governance offers online training for researchers conducting clinical trials sponsored by the University and/or taking place at the University at no cost to researchers. The training provides an overview of Good Clinical Practice (GCP) in the following areas:

  1. Research and GCP Foundations (3 modules)
  2. Stakeholder roles and responsibilities (3 modules)
  3. Practical Considerations in the conduct of clinical trials (4 modules)

The training takes approximately 10 hours and, once registered, you are given two months to complete it. It can be stopped and resumed at any time and can be done at your own pace. On completion of the training, a Certificate of Completion will be issued, which is valid for three years.
For further information please email

Site File Templates (Essential Documents) for Researchers

Clinical Trial Governance offers assistance with setting up and maintaining your Investigator Site File (ISF). It is important to establish the Investigator’s Site File (ISF) prior to the start of a clinical trial and it is the responsibility of the investigator to maintain and update information in the ISF throughout progress of the trial.

Site file templates are a useful resource for maintaining Essential Documents and used to evaluate the conduct and the quality of the clinical trial. We are providing researchers the following templates to assist in setting-up their ISF:

  • Site File Guidance
  • Site File Index
  • Delegation Log
  • Subject Identification Code List

Self-Audit Checklist

Clinical Trial Governance have developed a tool to assist researchers who want to monitor or audit their own clinical trials. The Self-Audit Checklist is designed to help researchers reflect on their research conduct; CTG are happy to assist with any issues raised by the process.

Monitoring can help to ensure that the trial is conducted, recorded, and reported in accordance with the protocol, Standard Operating Procedures (SOPs), Good Clinical Practice (GCP), and the applicable regulatory requirements.

For further information please email