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Clinical Trial Management System

NSW Health is introducing new software to support the delivery of clinical trials and research within public hospitals

NSW Health has launched a clinical trial management system (CTMS) 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 trial information, and tracking deadlines and milestones.

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

What is a Clinical Trial Management System?  

A clinical trial management system (CTMS) is software which enables oversight and management of clinical trials or clinical research. The software is online and accessed via a website and secure login using single sign on via Stafflink. NSW Health has contracted a company called Advarra to provide five linked systems which will comprise the ‘Statewide CTMS’.

These five systems are:

  1. Clinical Conductor: This is the core CTMS systemused by clinical trial staff. Clinical conductor has two linked parts:
    • Clinical Conductor Enterprise (CCE): used by trial managers, start-up specialists and study coordinators to build the study; link fees to trial items, set visit frequencies, and manage finances.
    • Clinical Conductor Site (CCS): used by study coordinators, research nurses, and investigators to store patient information and manage patient visits.
  2. eReg: eReg is a secure online document storage system accessible by clinical trial staff and external monitors. This system supports FDA CFR part 11; meeting the requirements of the US Food and Drug Administration as a secure and valid electronic signature system. eReg can replace hardcopy Investigator Site Files and supports electronic delegation, training, and signature.
  3. eConsent: provides a secure electronic platform for consent documents, so clinical trial consent can be reviewed and signed by participants wherever they are.
  4. eSource: enables the capturing of source data for investigator led trials. This platform is for later phase activation.
  5. CCText: enables two-way text messaging between participants and trial sites

Project progress?

NSW Health, through the Office for Health and Medical Research, began work on the Statewide CTMS program in mid-2020 with initial consultation with the sector to seek input about specific needs and scoping requirements for a clinical trial management system which could be applicable across the state.

Advarra, the preferred vendor, was contracted in August 2021 for a 5-year licence in line with NSW Health ICT procurement policies. The system is configured to meet the needs of NSW public health organisations. NSW eHealth has thoroughly tested the system to ensure compliance with NSW Health cybersecurity requirements.

Training of the first end-users began in August 2022, and the program has now progressed to a stepped training and implementation stage.

In mid-November 2022, system went live in the Pilot LHDs, with remaining LHDs following in early 2023.

Flow chart showing stages of CTMS



When will the CTMS be rolled-out at my LHD?

There will be a staggered roll-out of the CTMS throughout 2023. By staggering roll-out, we are best able to maximise support and resources for each LHD.

The staged roll-out of the CTMS

Milestone Local Health District Estimated Go-Live
Pilot LHDs: Illawarra Shoalhaven and Northern Sydney November 2022 – Live!
Phase 1 LHDs: Western NSW, Hunter New England, Central Coast and South Eastern Sydney February 2023 – Live!
Phase 2 LHDs: Sydney, Northern NSW and Mid North Coast Q1 2023
Phase 3 LHDs: Murrumbidgee, Nepean Blue Mountains and Southern NSW Q2 2023
Phase 4 LHDs: Western Sydney, Far West and  Justice Health and Forensic Mental Health Network Q2 2023

Frequently asked questions

For more information

For more information
For more information about CTMS support and training, or any other CTMS related information, send us an email.

Contact the CTMS team

NSW Health Staff can access CTMS information and resources through the CTMS SharePoint site:

Updated 4 weeks ago