Assessment outcomes data and lessons learnt - National Clinical Trials Governance Framework

Summary of accreditation outcomes and lessons learnt from the assessment of health service organisations (HSOs) against the National Clinical Trials Governance Framework (NCTGF).

Overview

The purpose of this page is to provide a national aggregation of assessment outcomes against the NCTGF to provide an indicator to the sector on implementation progress.

Assessments have been undertaken within HSOs (including day procedure facilities) that provide a clinical trial service. Performance is measured against a maturity scale. See Maturity rating for clinical trial service assessment - Fact sheet.

Reporting period

The figures below provide information on the number and percentage of HSOs that have either registered or completed assessments to the NCTGF, along with the actions commonly rated initial and established systems across the sector.

The reporting period commenced in May 2023 and data is updated monthly.

Public reporting

Across the maturity scale period individual performance of an HSO against the NCTGF will not be publicly reported.

The intent of a maturity determination during assessments is to provide HSOs with a quality improvement measure for their clinical trial service ahead of formal assessment under the Australian Health Service Safety and Quality Accreditation Scheme.

Maturity scale

The NCTGF is made up of 27 actions across the Clinical Governance and Partnering with Consumer Standard of the NSQHS Standards. Each action is awarded a rating after assessment. The rating scale is as follows:

decision matrix for the maturity rating scale for the National Clinical Trials Governance Framework

Registering for assessment

It is the role of state and territory health departments to identify and register eligible HSOs within their jurisdiction for assessment to the NCTGF, alongside routine processes for registering HSOs for assessment to the NSQHS Standards.

If there is uncertainty regarding accreditation requirements, contact your state and territory health department who regulates accreditation. See state and territory health department contact details.

Reporting period

The reporting period commenced in May 2023 and data is updated monthly.

Public reporting

Across the maturity scale period individual performance of an HSO against the NCTGF will not be publicly reported.

Maturity scale

Registering for assessment

Assessment outcomes data

Maturity ratings

During the first assessment cycle each applicable action of the NCTGF is rated in accordance with the maturity rating scale and the HSO given an overall maturity rating for their clinical trial service provision based on the sum of these scores.

It is important to note that even if a minor part of an applicable action is not met, then that action will be awarded a 'growing' rating and this will impact the overall rating a health service organisation receives against the maturity scale for their clinical trial service. See Maturity rating for clinical trial service assessment - Fact sheet.

Lessons learnt

Initial ratings

Planning ahead of assessment - identification of not-applicable actions

Members of the clinical trial workforce should communicate with safety and quality teams within their HSO to identify the accrediting agency that has been procured and confirm the scope of assessment to the NCTGF.

It is important for HSOs to establish an ongoing dialogue with their accrediting agency to appropriately plan for assessment. Further information is included in Fact sheet 17: Short notice accreditation assessment.

Key topics for discussion during the Planning Phase include:

Determination of ‘not-applicable’ actions of the NCTGF that may apply to the HSO based on their service level context for clinical trials. Refer to Advisory AS18/01: Advice on not applicable actions.
Processes to regularly share information, including throughout the accreditation cycle and during assessment
Approaches to conducting on-site assessment including access arrangements to the site, systems and key members of the clinical trial workforce.

Action 1.11 – Incident Management

The aim of incident management systems in HSOs is to incorporate improved and updated approaches to effectively manage incidents, with the view to proactively reduce preventable patient harm.

It relies on strong governance arrangements to enable the HSO to effectively and efficiently identify risk, develop mitigation strategies, including processes to analyse and evaluate risks and uses risk assessments to set priorities for and to improve the safety and quality of clinical trial service provision.

A fact sheet is being developed by the Commission to describe the intent of Action 1.11 of the NCTGF with suggested strategies and related examples to support best practice incident management and open disclosure principles for clinical trial service provision among HSOs.

Assessment cycles

HSOs providing a clinical trial service must be assessed at least once to the NCTGF.

Assessment to the NCTGF operates under the short notice assessment process (SNAP) format. SNAP commenced in July 2023 and is mandatory for the accreditation of health services to the NSQHS Standards and where applicable, the NCTGF.

A standard accreditation cycle is three-years. Despite the launch of the NCTGF in May 2023, timings as to when a SNAP occurs will be variable across HSOs and is influenced by:

When the HSO moved from announced to short notice assessments
When they opened/registered for assessment.

For example, HSOs that moved to short notice earlier in their own accreditation cycle are likely to have commenced a new cycle in May, which will be different for those who moved mid-way through a cycle.

This means there is not an official end date for the maturity scale in recognition that HSOs were at varying stages of their own accreditation cycles when the NCTGF was launched. Fact sheet 18 provides breakdown around the timings of short notice assessment and related cycles.

Members of the clinical trial workforce are also encouraged to engage with their safety and quality teams to understand their HSOs own accreditation cycle to prepare for assessment to the NCTGF.