Good Clinical Practice (GCP) Inspection Program
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.
About the Good Clinical Practice Inspection Program
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:
Medicines and biologicals
You should refer to the current version of the ICH GCP E6.
Medical devices
- International Organisation for Standardisation (ISO) 14155 – Clinical Investigation of Medical Devices for Human Subjects – Good Clinical practice (ISO 14155).
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.
GCP Inspection Guidance
We have published Preparing for Good Clinical Practice (GCP) inspections Guidance which describes:
- the type of inspections we may conduct
- who we inspect
- how we prioritise and schedule GCP inspections
- how to prepare for an inspection
- the inspection process, and
- how we report and follow-up on inspection.
Metrics reports
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.
Past webinar presentations
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WebinarsAbout the inclusion of medical devices to the GCP inspection program and the recent updates to the GCP inspection program guidance document in what to expect and how to prepare for an inspection. A recording of the webinar will be available.
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PresentationsWe showcased changes to the Clinical Trials Notifications (CTN) form and explained how the review of CTNs for the highest risk medical device clinical trials will operate in practice.
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WebinarsThis presentation provides an update on the GCP Inspection Program implemented in 2022.
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WebinarsA webinar to provide an overview on the new Good Clinical Practice (GCP) Inspection Program guidance document.
Contacts
For any GCP-related enquiries, please email GCP.Inspection@health.gov.au.