The National Standard Operating Procedures for Clinical Trials in Australia (National SOPs) have been agreed to by all states and territories to provide nationally consistent guidance to organisations and people who conduct clinical trials.
The National SOPs have been revised to:
- Integrate teletrial principles
- Include SOP 14: Database Development and Data Management in Clinical Trials
- Reflect guidance documents and updates to key legislation, including:
- International Council for Harmonisation Guideline for Good Clinical Practice (2025) and related TGA comments
- National Statement on Ethical Conduct in Human Research (2025)
- Declaration of Helsinki (2024)
- National Clinical Trials Governance Framework (2022)
- Australian Clinical Trial Handbook (2024)
- Australian Code for the Responsible Conduct of Research (2018)
Together, these revisions verify the National SOPs as a nationally consistent framework to support the conduct of clinical trials. This will enhance regulatory clarity, improve consistency and strengthen Australia’s standing as a preferred destination for high‑quality clinical trials.
Consultation on the Draft National SOPs is open until 20 May 2026.
Scan the QR code or click the link to access the consultation.
An information session will be held on Wednesday, 6 May, 11:00 am-12:00 pm AEST.
Register to attend. For further enquiries, please contact IGPRG@health.gov.au.
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National Standard Operating Procedures for Clinical Trials in Australia
