These assessments will be aligned to the National Safety and Quality Health Service (NSQHS) Standards accreditation surveys. Accrediting agencies will coordinate the assessment of clinical trial services when the health service organisation is undergoing assessment to the NSQHS Standards.
As clinical trial services are a new service type undergoing assessment, health services will be assessed to the actions in the Governance Framework for clinical trial service provision once in the first three years, against a maturity scale. That is, health services will be assessed as either having Established systems, Growing systems, or Initial systems in place to meet the actions in the NSQHS Clinical Governance Standard and the Partnering with Consumers Standard, as provided in the Governance Framework.
Accrediting agencies will negotiate with each health service organisation the additional assessment time and / or assessors required to ensure clinical trial sites are fully assessed.
Short notice assessments
From July 2023, short notice assessments will be mandatory for all health service organisations assessed to the NSQHS Standards.
All health services need to fully comply with the requirements of the NSQHS Standards for clinical and corporate service provision and have processes in place to demonstrate compliance at any time.
All eight NSQHS Standards will be assessed during a short notice assessment, which will occur once every three years. Health services with clinical trial services will include assessment to the Governance Framework.
Contact the team for more information on short notice assessments and the assessment of clinical trial services.
About the Governance Framework
The National Clinical Trials Governance Framework embeds clinical trials into routine health service provision under the Australian Health Service Safety and Quality Accreditation Scheme. Health service organisations will be assessed concurrently for clinical and corporate services and clinical trial service provision.
More information
Visit safetyandquality.gov.au/clinical-trials or contact HMR@safetyandquality.gov.au.
