The Clinical Trial Management System (CTMS) is available for all clinical trials conducted in NSW public health organisations and provides a shared online repository for clinical trial management.
Storage and organisation of clinical trial operational data within the CTMS aims to achieve streamlined financial management, participant management, forecasting and reporting.
The system supports public hospitals and health services to meet accreditation obligations under the National Clinical Trials Governance Framework.
What is a Clinical Trial Management System?
A CTMS is software which enables oversight and management of clinical trials. The NSW Health CTMS is located within a secure website accessible to staff via single sign on.
NSW Health contracted Advarra to provide three linked systems which comprise the ‘Statewide CTMS’.
These three systems are:
Clinical Conductor
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, report, and manage finances.
Clinical Conductor Site (CCS): used by study coordinators, research nurses, and investigators to manage patient information and visits.
eReg
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. Use of eReg is optional.
CCText
A text message application that enables trial sites to communicate important appointment information and reminders to participants via text messages. Use of CCText is optional.
Frequently asked questions
The CTMS is administrative software designed to support the management of clinical trials. The primary users of this software will be clinical trial coordinators, nurses and managers working in NSW public healthcare organisations.
Comprehensive training is essential for the successful implementation and quality use of the NSW Health Statewide CTMS. The CTMS project team have developed online training videos and resources to support users. These resources are available to NSW Health staff via the NSW Statewide CTMS SharePoint site.
It is mandatory for all eligible clinical trials to be entered into the CTMS, including investigator led, collaborative and commercial clinical trials. NSW Health staff are the primary users of the CTMS to manage clinical trial operations.
The core component of the CTMS, Clinical Conductor, is for the organisation and oversight 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 current processes.
Clinical trial monitors can access the eReg system (eISF), enabling them to remotely monitor clinical trial documents, staff credentials, training, and delegation logs. The coordination of review sessions and monitor permissions are handled by NSW Health clinical trial staff.
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.
The CTMS is web-based software accessible through a standard URL, like any other website. This feature means the CTMS 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.
The Statewide CTMS project is managed by our project team within the Ministry of Health. We serve as the central point of contact for all system-related matters and work closely with all districts to support implementation and collaboration.
Any clinical trial that meets all the following criteria must be entered into the NSW Health Statewide CTMS.
- 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).
- 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.
- SSA authorisation is received on, or after, 1 September, 2023.
- The clinical trial captures individual patient data.
The CTMS has the capability to share study builds across sites and districts, reducing the timeframes to start up multi-site studies.
Contact the CTMS team if you need more information or have any questions.