National Clinical Trials Governance Framework

National Clinical Trials Governance Framework

Information sheet

Please see our information sheet for clinical trial participants and their families on the National Clinical Trials Governance Framework.

See information sheet

The Australia Commission on Safety and Quality in Health Care confirmed in May 2023 that all health service organisations conducting clinical trials will be assessed against the National Clinical Trials Governance Framework (NCTGF).

The NCTGF assessments will be conducted concurrently with the existing hospital accreditation surveys. The purpose of this framework is to ensure accountability of staff, patients and the community. This will ensure that clinical trials are delivered with high quality, integration into clinical care and provisions of continual improvement.

Short notice assessments under the Short Notice Accreditation Assessment Program (SNAAP) will be mandatory for all health service organisations assessed to the National Safety and Quality Health Service (NSQHS) Standards.

All health service organisations 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.

SCHN will be undergoing a single SNAAP against all eight NSQHS Standards between July 2023 and February 2024. Clinical and corporate service provision will be assessed against all eight NSQHS standards. Clinical trial service provision will also be included in this SNAAP and assessed against a maturity scale – that is, having an established system, a growing system or an initial system in place to meet two of the standards – Clinical Governance Standard and Partnering with Consumers Standard.

Please contact the SCHN Research Governance Office via email for further information.