Assessment to the National Clinical Trials Governance Framework
Accreditation for the provision of clinical trial services located within health service organisations (HSOs) provides assurance to the community that a healthcare service meets expected safety and quality standards. It is a formal program in which trained, independent reviewers assess HSO's evidence of implementation against applicable actions in the National Clinical Trials Governance Framework (NCTGF).
Key messages
- Assessment to the NCTGF began in May 2023
- For the first accreditation cycle, HSOs will be assessed against a maturity scale for the safety and quality of their clinical trial service - see Fact sheet 18: Scheduling for short notice assessment
- Assessments will occur alongside an HSOs routine assessment to the NSQHS Standards - see Flow chart of an assessment to NSQHS Standards
- Advice on not-applicable actions, as they relate to the NCTGF, is in development to align with Advisory AS18/01: Advice on not applicable actions
Outline
Assessment overview
All public and private hospitals and day procedure services (HSOs) providing a clinical trial service are required to be assessed against applicable actions of the NCTGF relevant to their own level of service delivery. This assessment is conducted in accordance with the Australian Health Service Safety and Quality Accreditation Scheme (AHSSQA Scheme) by an accrediting agency approved by the Commission.
For HSOs already entered into a contractual agreement with an accrediting agency as part of their accreditation to the National Safety and Quality Health Service (NSQHS) Standards, this agency can also undertake an assessment to the NCTGF.
Implementation of the NCTGF 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 clinical trial services have implemented the relevant actions and award a maturity rating for each action.
- Advise of any actions rated as initial systems at the time of assessment and share strategies for quality improvement.
- Provide an assessment report to the health service organisation within five business days of the assessment.
Short notice assessment
Accreditation to the NCTGF is conducted via a Short Notice Assessment (SNA) format. The Commission has developed resources to support health service organisations with the process.
Maturity scale
To give HSOs time to implement the NCTGF, for the first accreditation cycle, they will be assessed against a maturity scale. This means HSOs will be assessed as either having Established, Growing, or Initial systems in place to meet applicable actions of the NCTGF for clinical trial service provision. The purpose of a maturity determination as an assessment outcome during this period is to:
- introduce the clinical trials sector to the processes and language of HSO accreditation
- serve as a quality improvement guide for HSOs to receive an external review of the safety and quality of their clinical trial service
- identify gaps (major or minor) and address them by investing in ongoing safety and quality measures against applicable actions of the NCTGF
- revise and/or implement robust systems and processes to deliver safe and high-quality clinical trial services to prepare for full accreditation at the next accreditation cycle according to the NSQHS Standards under the AHSSQA Scheme.
Decision Matrix
| 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 accreditation cycle, HSOs will transition fully to the assessment of their clinical trial services under the NSQHS Standards rating scale. They will be assessed as either having met or not met the actions within the NCTGF and receive 60 business days to remediate or risk accreditation of the entire health service.
Assessment overview
All public and private hospitals and day procedure services (HSOs) providing a clinical trial service are required to be assessed against applicable actions of the NCTGF relevant to their own level of service delivery. This assessment is conducted in accordance with the Australian Health Service Safety and Quality Accreditation Scheme (AHSSQA Scheme) by an accrediting agency approved by the Commission.
For HSOs already entered into a contractual agreement with an accrediting agency as part of their accreditation to the National Safety and Quality Health Service (NSQHS) Standards, this agency can also undertake an assessment to the NCTGF.
Implementation of the NCTGF 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 clinical trial services have implemented the relevant actions and award a maturity rating for each action.
- Advise of any actions rated as initial systems at the time of assessment and share strategies for quality improvement.
- Provide an assessment report to the health service organisation within five business days of the assessment.
Short notice assessment
Accreditation to the NCTGF is conducted via a Short Notice Assessment (SNA) format. The Commission has developed resources to support health service organisations with the process.
Maturity scale
To give HSOs time to implement the NCTGF, for the first accreditation cycle, they will be assessed against a maturity scale. This means HSOs will be assessed as either having Established, Growing, or Initial systems in place to meet applicable actions of the NCTGF for clinical trial service provision. The purpose of a maturity determination as an assessment outcome during this period is to:
- introduce the clinical trials sector to the processes and language of HSO accreditation
- serve as a quality improvement guide for HSOs to receive an external review of the safety and quality of their clinical trial service
- identify gaps (major or minor) and address them by investing in ongoing safety and quality measures against applicable actions of the NCTGF
- revise and/or implement robust systems and processes to deliver safe and high-quality clinical trial services to prepare for full accreditation at the next accreditation cycle according to the NSQHS Standards under the AHSSQA Scheme.
Decision Matrix
| 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 accreditation cycle, HSOs will transition fully to the assessment of their clinical trial services under the NSQHS Standards rating scale. They will be assessed as either having met or not met the actions within the NCTGF and receive 60 business days to remediate or risk accreditation of the entire health service.
