Clinical Trial Management System
NSW Health is introducing new software to support the delivery of clinical trials and research within public hospitals
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 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:
- 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.
- 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.
- eConsent: provides a secure electronic platform for consent documents, so clinical trial consent can be reviewed and signed by participants wherever they are.
- eSource: enables the capturing of source data for investigator led trials. This platform is for later phase activation.
- 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.
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
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Who can use the CTMS?
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Who can use the CTMS?
The CTMS is administrative software designed to support the management of clinical trials. The primary users of this software will be clinical trials coordinators, trial nurses and trial unit managers working in NSW public healthcare organisations.
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Is CTMS training being provided?
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Is CTMS training being provided?
Comprehensive training is essential for the successful implementation of the CTMS at NSW public hospitals. The CTMS project team is providing training and support to clinical trial staff as they transition from current workflows into the CTMS system.
CTMS training was delivered in a staggered approach throughout the last quarter of 2022, beginning with LHDs within the Pilot and Phase 1 stages. Training is continuing in 2023 for Phase 2, 3 and 4 LHDs.
Training has been provided in a variety of approaches to suit individual learning styles and availability. The CTMS Project Team will continue to provide:
• Live webinars with hands-on training in a sandbox system
• In-person training events
• Self-directed learning options including video tutorials and online quick reference guides
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Is CTMS support being provided?
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Is CTMS support being provided?
Each Local Health District has access to a change manager who is the primary point of contact for local support and training. Trial units can organise a specific time and day with the Change Manager for in-person training and troubleshooting of the system.
Support may also be provided by Super Users. Super Users are members of each trial unit who have received additional training and are proficient in using CTMS. They can be any member of the trial unit team who is interested in learning more about CTMS and is keen to be a trainer to assist their colleagues.
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Can the CTMS be accessed by external monitors?
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Can the CTMS be accessed by external monitors?
The core component of the CTMS, Clinical Conductor, is for the organisation and management of patients and site administration and finances. It does not contain clinical data, and so external sponsors and monitors will not have access to this system. At this stage, patient clinical data for trials will be reviewed by monitors through the usual medical record system. Clinical trial monitors will be provided access to the eReg system to support remote document monitoring of clinical trials. Monitors can secure access required documents for review by invitation from trial staff in eReg.
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What about security and privacy of information?
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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.
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How do staff access the CTMS?
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How do staff access the CTMS?
The CTMS is an online software that can be accessed using a URL, just like any other website. Logon to the CTMS is by single sign on with Stafflink. As the CTMS is a web-based program, it can be easily accessed on computers, tablets and mobile devices in office and clinical spaces. This will provide greater access and flexibility for clinical trial staff.
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Is it mandatory to use the CTMS?
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Is it mandatory to use the CTMS?
To ensure accurate data and realise the full benefits of a CTMS, new clinical trials are required to be entered after system go live. To make the transition to the new system as smooth as possible, sites will be supported with extensive training and Change Managers to ensure all new clinical trials are entered in the CTMS within the first 12 months of activation.
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Who manages the CTMS project?
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Who manages the CTMS project?
The Statewide CTMS Project is managed by the CTMS Project Team. The team sits within the NSW Health Office for Health and Medical Research (OHMR) at the Ministry of Health. The CTMS Project Team is the central point of contact for all CTMS related matters. The CTMS Project Team is working with all LHDs to coordinate the roll out of the CTMS.
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What type of clinical trials are required to be entered into the CTMS?
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The CTMS is for any clinical trial, including collaborative, investigator-initiated, and commercially sponsored trials. Observational studies or clinical research studies may be entered into the CTMS.
For more information
For more information
For more information about CTMS support and training, or any other CTMS related information, send us an email.
NSW Health Staff can access CTMS information and resources through the CTMS SharePoint site: https://nswhealth.sharepoint.com/sites/NSWH-CTMS
Updated 4 weeks ago