The government is now operating in accordance with the Guidance on Caretaker Conventions, pending the outcome of the 2025 federal election.
Learn about GCP inspections of clinical trial sites of investigational biologicals, medicines and medical devices.
Update October 2024: A metrics report covering inspections carried out in 2023 and 2024 will be published in the first quarter of 2025.
In 2022, we implemented an ongoing risk-based Good Clinical Practice (GCP) Inspection Program.
Clinical trials of medicines, biologicals and devices, regulated under the Clinical Trial Notification (CTN) scheme or Clinical Trial Approval (CTA) schemes, are subject to our GCP Inspection Program.
GCP is an international ethical and scientific quality standard for designing, conducting, recording and reporting clinical trials. Compliance with GCP provides assurance that the rights, safety and well-being of clinical trial participants are protected and that the trial data generated are credible.
All clinical trials carried out under the CTN or CTA schemes must be in accordance with the relevant GCP guideline(s). We recognise the following internationally accepted GCP guidelines:
You should refer to the current version of the ICH GCP E6.
You should refer to the current version of ISO 14155. Sites will need to obtain their own copy of ISO 14155 which may incur a cost. We cannot provide a copy of this standard.
We have published Preparing for Good Clinical Practice (GCP) inspections Guidance which describes:
We publish annual GCP metrics reports on inspection findings and compliance expectations. Use the metrics report to help ensure your trial is compliant and ready for an inspection. You can self-assess if similar compliance issues may need to be addressed at your site.
The information published does not identify individual clinical trial sponsor or investigator or investigator site names.
For any GCP-related enquiries, please email GCP.Inspection@health.gov.au.
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