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National clinical trials governance framework

The Commission has developed the draft National Clinical Trials Governance Framework (Governance Framework), on behalf of all states and territories, as a first step towards accreditation of health services to conduct clinical trials.

The Governance Framework is a key element of the COAG Health Council’s revitalised clinical trials agenda. It also aligns with the Commission’s existing NSQHS Standards, particularly the Clinical Governance and Partnering with Consumers standards.

In November 2019, the COAG Health Council endorsed the draft Governance Framework, and agreed for the Commission to undertake a pilot in health service organisations currently accredited to the NSQHS Standards. The pilot of the Governance Framework was announced on 25 February 2020. Twelve pilot sites were selected to provide voluntary feedback on the Governance Framework, and supporting tools and resources. The pilot is anticipated to be completed in late 2020.