National Standard Operating Procedures for Clinical Trials in Australia

The National Standard Operating Procedures for Clinical Trials, including Teletrials, in Australia (National SOPs) were published in February 2021 and endorsed for implementation by all jurisdictions, the Therapeutic Goods Administration (TGA) and the National Health and Medical Research Council (NHMRC).

Since their publication, the major underpinning reference materials have been updated. The revised National SOPs now adhere to the following documents:

• The International Council for Harmonisation Guideline for Good Clinical Practice (ICH GCP E6(R3)) (ICH, 2025) and related TGA comments
• The National Statement on Ethical Conduct in Human Research (National Statement) (Australian Research Council, NHMRC, Universities Australia, 2025)
• The Declaration of Helsinki (World Medical Association, 2024)
• The National Clinical Trials Governance Framework (Australian Commission on Safety and Quality in Health Care, 2022)
• The Australian Clinical Trial Handbook (TGA, 2024)
• The Australian Code for the Responsible Conduct of Research (Australian Research Council, NHMRC, Universities Australia, 2018)

On 19 March 2026, the Inter-Governmental Policy Reform Group (IGPRG) endorsed the proposed approach to commence sector-wide consultation with key stakeholders on the review of the National SOPs.

The Clinical Trials Policy team invites you to provide feedback on the draft revised National SOPs, to help ensure they:

• Align with the underpinning reference guidelines and regulations
• Use consistent and appropriate terminology
• Are relevant and applicable to your area

If you would like to provide feedback to this consultation, please email your feedback in paragraphs, or as a Word document with tracked changes to lwaheed@mtaa.org.au.