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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 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.

What is a Clinical Trial Management System?  

A clinical trial management system (CTMS) is software which enables oversight and management of clinical trials. The software is online and accessed via a website and secure login. The Office for Health and Medical Research has contracted a company called Advarra to provide four linked systems which will comprise the ‘Statewide CTMS’.

These four systems are:

  1. Clinical conductor: This is the core CTMS system used by clinical trial staff. Clinical conductor has two linked parts:
    • clinical conductor enterprise: used by trial managers, start-up specialists and study coordinators to build in the study; link fees to trial items, set visit frequencies, and manage invoices.
    • clinical conductor site: used by study coordinators, research nurses, and investigators to manage patient visits and upload documents.
  2. eReg: eReg is a secure online document storage system accessible by clinical trial staff and external monitors. This system is fully FDA CFR part 11 compliant which means it meets the requirements of the US Food and Drug Administration to be accepted as a secure and valid electronic signature system. eReg can replace hardcopy Investigator Site Files and Trial Master Files and supports electronic delegation, training, and signature.
  3. eConsent: provides a secure electronic platform for consent documents, enabling clinical trial consent to 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.

Project progress?

NSW 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.

The preferred vendor was contracted in August 2021 for a 5-year licence in line with NSW ICT procurement policies.

The program is currently in the development stage and it is being adjusted to meet NSW state needs and tested to ensure compliance with NSW Health cybersecurity requirements.

System training will commence at Local Health Districts from May in line with their order of implementation, followed by go live soon after.

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

There will be a staggered roll-out of the CTMS throughout 2022. By staggering roll-out, we are best able to maximise support and resources for each LHD.

The staged roll-out of the CTMS

Milestone Date
Pilot LHDs: Illawarra/Shoalhaven, Northern Sydney
Phase 1 LHDs: Western NSW, Hunter/New England, Central Coast, South Eastern Sydney
Phase 2 LHDs: Northern NSW, Mid North Coast, Western Sydney
Phase 3 LHDs: Sydney, Murrumbidgee
Phase 4 LHDs: Far West, Nepean Blue Mountains, Southern NSW, Justice Health and Forensic Mental Health Network

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

 

Updated 8 months ago