Clinical Trials – Phase 2 Advisory Committee Communique - Meeting 6, 1 October 2021

Topics:Advocacy

This Communique provides an update from The Australian Commission on Safety and Quality in Health Care (the Commission) on Clinical Trials – Phase 2 Advisory Committee (Advisory Committee) meetings.

We gratefully acknowledge the role of the Commission in leading this work.

Background

In November 2019, the National Clinical Trials Governance Framework (Governance Framework) was endorsed by all Health Ministers. The Governance Framework provides the first step toward the accreditation of health services for the conduct of clinical trials. The Australian Commission on Safety and Quality in Health Care (the Commission) conducted a national pilot of the Governance Framework between September 2020 and March 2021.

Clinical Trials – Phase 2 Advisory Committee: Meeting 6

The final meeting of the Advisory Committee was held on 1 October 2021 via videoconference. At the meeting, members discussed the final Governance Framework and the Pilot Report.

The Governance Framework Pilot Report has been provided to the Commission’s Inter-Jurisdictional, Private Hospital Sector Committees and Board and, the Clinical Trials Project Reference Group for endorsement. The Commission will then seek to gain agreement through Health Council in the coming weeks. The Commission is recommending implementation from July 2022 with health services being assessed against the maturity scale for the first three years. During that time, the Commission will develop the assessor training tools and update the resources to support health service organisations as they implement the Governance Framework.

Enquiries

If you would like to be added to the Clinical Trials – Phase 2 project distribution list and receive further correspondence about the progress of this project, please email your details to HMR@safetyandquality.gov.au

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