National Clinical Trials Governance Framework Pilot: Update

Clinical Trials – Phase 2 Advisory Committee
Communique - Meeting 4, 30 March 2021

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

This Communique was provided to participants to update their nominating organisations and other key agencies about the project.

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 4

The fourth meeting of the Advisory Committee was held on 30 March 2021 via videoconference. At the meeting, members received an update and early insights on the Governance Framework pilot. The Commission invited members to come forward with any feedback or issues received from their network on the pilot process.

Next Steps

In the coming weeks, the Commission project team will:

  • Collate the data and information gathered through the pilot process.
  • Include outcomes and recommendations in the final pilot report.
  • Progress the pilot outcomes and recommendations through the Commission’s governance process and the Health Council for endorsement by all Australian Health Ministers.

The pilot report will be provided to the Advisory Committee Members at the next Advisory Committee meeting in June 2021.

The Commission will be recommending implementation from 2022 with health services being assessed against the maturity scale for the first three years.

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 CTGovernance@safetyandquality.gov.au.

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