NSW Health and Medical Research

Clinical Trial Management System

NSW Health has introduced a new software system to support the delivery of clinical trials across the health system. 

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 manages planning, performing and reporting functions, and maintains participant trial information, tracks deadlines and milestones for streamlined trial management.

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. The software is a secure website accessible to NSW Health staff via single sign on.

NSW Health has contracted Advarra to provide three linked systems which will comprise the ‘Statewide CTMS.’

These three 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 (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: is a secure online document storage system accessible to 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. CCText: is a text message application that enable trial sites to communicate important appointment information and reminders to participants via text

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 across 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 has been 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 and implementation has been a staggered approach with CTMS training for the first end-users beginning in August 2022 and official CTMS ‘Go Live’ occurring by June 2023. Currently there are 14 local health districts and one specialty health network with access to the NSW Health Statewide CTMS.

From the 1st of September 2023 it will be mandatory for all new clinical trials to be entered into the CTMS. Eligible clinical trials must meet all the following criteria:

  1. Meets the World Health Organisation (WHO) definition of a clinical trial.
  2. Conducted at NSW public health facilities or services (i.e., requires an SSA at that district), by a NSW Health employee or contingent worker.
  3. SSA authorised on, or after September 1st, 2023.
  4. The clinical trial captures individual patient data.

CTMS auditing and district reporting will commence from September 2023 and continue quarterly.

Flow chart showing stages of CTMS

 

 

Frequently asked questions

  • Who can use the CTMS?

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: https://nswhealth.sharepoint.com/sites/NSWH-CTMS

Updated 10 months ago