Good Clinical Practice (GCP) Inspection Program

Update May 2024: Clinical trials of medical devices are now in scope of the GCP inspection program. 

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 CTN or 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

• International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use Guideline for Good Clinical Practice (ICH GCP E6) with TGA annotations

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 guidance on our GCP Inspection Program for clinical trials involving medicines, biologicals and devices, 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. 

Good Clinical Practice Inspection Program metrics report July 2022 – December 2022 (pdf,247kb)

Past webinar presentations

Updates to the CTN form and first-in-human high-risk implantable or cardiac invasive medical device clinical trials, 14 March 2024

Insights from the TGA Good Clinical Practice (GCP) Inspection Program - Session one, 7 August 2023

Information on the TGA Good Clinical Practice (GCP) Inspection Program, 9 May 2022

Contacts

For any GCP-related enquiries, please email GCP.Inspection@health.gov.au.