Clinical Trials Management System (CTMS)
From September 2023 NSW Health Office for Health and Medical Research has mandated newly authorised interventional research on human participants or groups to be entered into the Clinical Trials Management System (CTMS).
The CTMS is a secure online platform supporting the management of research in NSW Public Health Organisations and will assist in the provision of evidence for accreditation purposes under the National Clinical Trials Governance Framework. The CTMS will not replace REGIS, and REGIS will continue to be the system used to manage ethics and governance approvals for research projects within NSW.
Any clinical trial that meets all of the following criteria must be entered into CTMS:
- Meets the World Health Organisation (WHO) definition of a clinical trial which involves prospectively assigning human participants or groups to health-related interventions to evaluate the effects on health outcomes. Interventions include, but are not restricted to drugs, surgical procedures, devices, behavioural treatments and preventive care (WHO, 2020);
- The clinical trial is conducted at a NSW Health public facility or service, by a NSW Health employee or contingent worker, requiring a SSA within that District;
- SSA authorisation is received on, or after, September 1st, 2023; and
- The clinical trial captures individual patient data.
If the research project meets the above criteria, evidence of entry into the CTMS (study ID page) is to be provided to the RGO as part of the SSA submission.
Register for access to CTMS.
For further information see the CTMS website or contact the MNCLHD RGO via email: MNCLHD-RGO@health.nsw.gov.au
For training, contact the CTMS team via email: MOH-StatewideCTMS@heatlh.nsw.gov.au