Clinical Trials

Clinical Trials Governance Framework Implementation Working Group

The Australian Commission on Safety and Quality in Health Care (ACSQHC), on behalf of all jurisdictions, developed the National Clinical Trials Governance Framework (Governance Framework) as the first step towards a nationally consistent approach to the accreditation of health services for the conduct of clinical trials. The Framework will ensure health service organisations comply with the actions in the National Safety and Quality Health Service (NSQHS) Standards 1 and 2 for clinical trial services as provided in the Framework, and to identify additional resources that may be required for SESLHD to meet implementation requirements.

Clinical trial governance framework working party meetings are being organised. If you would like to be part of the meetings – please email: SESLHD-RSO@health.nsw.gov.au
For clinical trial governance work plans:

Please email SESLHD-RSO@health.nsw.gov.au for further information or to be included in the working group for SESLHD implementation of the Clinical Trials Governance Framework.

Clinical Trial Management System (CTMS)

Please ensure that you have explored the new CTMS system. From 01 September 2023, NSW Health is mandating the use of the Clinical Trial Management System (CTMS) for all new clinical trials conducted across New South Wales.

All SESLHD clinical trial governance applications must include:

A screenshot of the study Minimum Data Set entered into the CTMS
The study CCID code

Clinical trials will not receive full governance authorisation until the study has been entered into the CTMS.

For CTMS training, resources and user accounts, please register here.