NSW Health & Medical Research | Clinical Trial Management System

NSW Health is introducing new software to support the delivery of clinical trials and medical 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 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.

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:

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.
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.
CCText: is a text message application that enable trial sites to communicate important appointment information and reminders to participants via text

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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 1^st 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:

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

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Who can use the CTMS?

Is CTMS training being provided?
Is CTMS training being provided?
Comprehensive training is essential for the successful implementation of the NSW Health Statewide CTMS. The CTMS project team is actively delivering training and support to clinical trial staff as they transition from current workflows to the CTMS.

A series of live online sessions for CTMS and eReg are available as well as a variety of training resources developed by the project team. These resources are available to NSW Health staff via the NSW Statewide CTMS SharePoint site.

Can the CTMS be accessed by external monitors?
Can the CTMS be accessed by external monitors?
The core component of the CTMS, Clinical Conductor, is for the organisation and overseeing of patient management, site administration and finances. It does not contain clinical data, and therefore external sponsors and monitors will not have access to this system. Currently, patient clinical data for trials will continue to be reviewed by monitors through the usual medical record system.
Clinical trial monitors can also access the eReg system, enabling them to remotely monitor clinical trial documents. The coordination of review sessions and monitor permissions are handled by NSW Health clinical trial staff.

What about security and privacy of information?
What about security and privacy of information?
The CTMS software and data are encrypted and hosted in a secure environment in accordance with NSW Government cybersecurity requirements. Access to the CTMS data is restricted to authorised NSW Health staff who work in clinical trials.

How do staff access the CTMS?
How do staff access the CTMS?
The CTMS is web-based software accessible through a standard URL, like any other website. Since the CTMS operates on the web, it can be conveniently accessed on various devices including computers, tablets, and mobile devices, both within office and clinical settings. This provides greater access and flexibility for clinical trial staff.

Is it mandatory to use the CTMS?
Is it mandatory to use the CTMS?
To ensure accurate data and realise the full benefits of a CTMS, all new clinical trials are required to be entered from September 1st, 2023. A study and patient minimum data set has been developed to assist in meeting accreditation requirements as well as LHD, state and national reporting. More information about the minimum data set can be found on the NSW Statewide CTMS SharePoint site.

Who manages the CTMS project?
Who manages the CTMS project?
The Statewide CTMS project is managed by the CTMS project team which operates within the NSW Health Office for Health and Medical Research (OHMR) at the Ministry of Health. This team is the central point of contact for all CTMS related matters and collaborates with all LHDs to support the transition to the CTMS.

What type of clinical trials are required to be entered into the CTMS?
Any clinical trial that meets all the following criteria must be entered into the NSW Health Statewide CTMS
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 SSA within that district.
3. SSA authorisation is received on, or after, September 1st, 2023.
4. The clinical trial captures individual patient data.

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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

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