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 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:
- 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.
- 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.
- eConsent: provides a secure electronic platform for consent documents, enabling clinical trial consent to 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.
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
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Who will use the CTMS?
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Who will 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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Will CTMS training be provided?
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Will CTMS training be provided?
Comprehensive training is essential for the successful implementation of the CTMS at NSW public hospitals. CTMS project team will provide training and support to clinical trial staff as they transition from current workflows into the CTMS system.
CTMS training will be delivered in a staggered approach throughout 2022. For LHDs within the Pilot and Phase 1 stages, training will begin in May 2022.
Training will be provided in a variety of approaches to suit individual learning styles and availability. We will be providing:
• 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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Will CTMS support be provided?
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Will CTMS support be provided?
Each Local Health District will have access to a dedicated change manager who will be 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 will 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?
Clinical trial monitors will be provided access to the eReg system to support remote document monitoring of clinical trials.
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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. 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 within 12 months of system go live. To make the transition to the new system as smooth as possible, sites will be supported with extensive training and local 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 CTMS.
For more information, please contact MOH-StatewideCTMS@health.nsw.gov.au
For more information
For more information
For more information about CTMS support and training, or any other CTMS related information, send us an email.
Updated 8 months ago