Advisory details
| Item | Details |
|---|---|
| Advisory number | CT25/01 |
| Version number | 1.0 |
| Publication date | September 2025 |
| Replaces | N/A |
| Compliance with this advisory | It is mandatory for approved accrediting agencies and Health Service Organisations (HSOs) to implement this Advisory. |
| Information in this advisory applies to |
|
| Key relationship | All NCTGF Standards |
| Attachment | None |
| Notes | Extension of the Maturity Rating Scale for the assessment of health service organisations (HSOs) conducting clinical trials services under the National Clinical Trial Governance Framework (NCTGF). Requirements under the Australian Health Service Safety and Quality Accreditation (AHSSQA) Scheme for the assessment of clinical trial services to the second edition of the National Safety and Quality Health Service Standards (NSQHS) leading to the introduction of the third edition. |
| Responsible officer | Suchit Handa Director, Measurement for Improvement Phone: 1800 304 056 Email: AdviceCentre@safetyandquality.gov.au |
| To be reviewed | August 2028 |
Purpose
To specify requirements for the use of the Maturity Rating Scale for National Clinical Trials Governance Framework (NCTGF) Assessment.
Issue
The National Clinical Trials Governance Framework (NCTGF) was introduced to embed clinical trial services within routine healthcare provision. The Australian Commission on Safety and Quality in Health Care (the Commission) recognises that HSOs across Australia are at different stages of implementing actions under the NCTGF. The Commission has applied a maturity rating scale to assist HSOs understand their current level of performance and build capability to meet the NCTGF requirements, regardless of their stage of implementation.
The maturity rating scale assists by:
- introducing the clinical trials sector to the processes and language of assessment
- providing an external review of the safety and quality systems of the clinical trial service to identify gaps and inform quality improvement
- supporting the HSOs to embed the safety and quality systems for clinical trial services within routine healthcare provision.
Assessment to the NCTGF commenced in May 2023. HSOs will become due for a second assessment from October 2025. To support clinical trials sites fully meet the NCTGF, the use of the maturity scale is to be extended.
Requirements
Assessment under the second edition of the NSQHS Standards
HSOs conducting clinical trials will be assessed to the NCTGF actions using the maturity rating scale, for the first accreditation cycle and all subsequent accreditation cycles conducted before 31 December 2029.
HSOs will be provided a rating using the maturity scale of ‘initial’, ‘growing’ or ‘established’ for each action assessed in their clinical trial services.
Assessment outcomes to the NCTGF occurring before 31 December 2029 will not impact the HSOs assessment outcome under the second edition of the NSQHS Standards.
Assessment under the third edition of the NSQHS Standards
From 1 January 2030, with the introduction of the NSQHS Standards (3rd ed.), all HSOs conducting clinical trials that have previously been assessed to the NCTGF, will be assessed using the rating scale applied to the NSQHS Standards and be subject to the same rules and timeframes specified under the Australian Health Service Safety and Quality Accreditation (AHSSQA) Scheme. The rating of actions from the clinical trial services will be considered in the overall assessment outcome.
If an established, accredited HSO with a newly established clinical trial services is assessed after 1 January 2030, the HSO can apply to the Commission for the clinical trials service to have its initial assessment to the NCTGF conducted using the maturity rating scale.
Newly established health service organisations commencing clinical trials services
From 1 January 2030, all newly established HSOs with clinical trial services operating at the time of commencement of services and undergoing interim assessments, will be assessed using the NCTGF maturity rating scale. There will be no remediation period or final assessment for the NCTGF assessment. The outcome of the initial assessment to the NCTGF will not impact the HSOs assessment outcome.
The second and subsequent accreditation cycle assessments will be subject to the same rules and timeframes specified under the AHSSQA Scheme and the rating of actions from the clinical trial services will be considered in the assessment outcome.