Clinical Trial Management System (CTMS)

NSW Health has secured a Clinical Trial Management System (CTMS) licence for all NSW public hospitals and health services conducting clinical trials.

The CTMS is a software system which will manage clinical trials in NSW. The system maintains and manages planning, performing and reporting functions, along with participant contact information, and tracks deadlines and milestones.

The electronic infrastructure of the CTMS is designed to assist the state’s clinical trials sector through reduced administrative burden, increased visibility of clinical trial activity, and improved financial management.

The CTMS has been rolled out and gone live across NSW LHDs over the last several months.

Use of the CTMS is now mandatory as of 1^st September 2023 for ALL NEW CLINICAL TRIALS that meet ALL of the following criteria;

1. 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 (WHO, 2020).

2. The clinical trial is conducted at NSW Health public facility or service, by a NSW Health employee or contingent worker, requiring a Site Specific Assessment (SSA) within that district.

3. HNE Site Specific Application (SSA) authorisation is received on, or after, September 1st, 2023.

4. Clinical trial captures individual patient data.

HNELHD Site Specific Assessment (SSA) authorisation is dependent on entering the clinical trial minimum data into the CTMS.

Please note use of the CTMS can occur at any time in the study start up process and it is recommended that trial sites start early during feasibility or HREC submission as 90% of the study minimum data set can be entered at this time in preparation for study activation.

All HNE Principal Investigators for clinical trials are to ensure the relevant team members have completed their CTMS training and competency assessment to access the CTMS.

Researchers are required to provide evidence of use of the CTMS as part of the SSA process in REGIS via the following;

Upload a screenshot into REGIS of the Study Details page including the CTMS Study CCID number located in the top-left corner of the study on the CTMS page.

For further information regarding CTMS training and access please visit the CTMS SharePoint Site or contact the CTMS Team at: MOH-StatewideCTMS@health.nsw.gov.au

For further information regarding the HNE SSA/CTMS compliance process please contact the HNE Research Governance Manager Kristy Morris kristy.morris@health.nsw.gov.au