Implementation and Assessment to the National Clinical Trials Governance Framework

Accreditation provides assurance to the community that a healthcare service meets expected standards for safety and quality. It is a formal program in which trained independent reviewers assess a healthcare service’s evidence of implementation of the National Clinical Trials Governance Framework.

Assessment overview

Assessment to the Governance Framework is conducted by an accrediting agency approved the Commission. Health service organisation will need to enter a contractual agreement with an accrediting agency (this will usually be the same as the one assessing the National Safety and Quality Health Service (NSQHS) Standards).

Implementation of the Governance Framework will occur in two stages. In the first stage of implementation, the process will involve assessment against a maturity scale. The accrediting agency will:

  • Review evidence provided by health service organisations to demonstrate the clinical trial services have implemented the relevant actions and award a maturity rating for each action (established systems, growing systems or initial systems)
  • Advise of any actions rated as initial systems at the time of assessment
  • Provide an assessment report to the health service organisation within five business days of the assessment.

Maturity scale for health service organisation assessment

To give health service organisations time to implement the Governance Framework, for the first three-year accreditation cycle, they will be assessed against a maturity scale. That is, health service organisations will be assessed as either having Established systems, Growing systems, or Initial systems in place to meet the National Safety and Quality Health Service (NSQHS) Standards (as provided in the Governance Framework) for clinical trial service provision.

Established systems Evidence to demonstrate that all requirements of an action are in place and integrated within the operations of the health service organisation
Growing systems Evidence to demonstrate that some of the requirements of an action are in place, with plans prepared to implement improvements to address identified gaps
Initial systems Evidence to demonstrate that the requirements of the action are yet to be commenced or implemented

Beyond the first three-year accreditation cycle, health service organisations will transition fully to the assessment of their clinical trial services under the Australian Health Service Safety and Quality Accreditation Scheme (AHSSQA) Scheme and be assessed as either having met or not met the actions within the NSQHS Standards Clinical Governance Standard and Partnering with Consumers Standard (as provided in the Governance Framework) and receive 60 business days to remediate.

Assessments will commence in March 2023

Assessment process, rules and requirements