Electronic study management systems
Clinical trials have historically been very paper heavy, as they need to maintain extensive records for trial regulators and to comply with various guidelines such as Good Clinical Practice. As with everything, triallists are looking to move to use more paper light systems with a growing interest in electronic solutions.
Electronic study management systems are a great solution.
- Multi-centre studies can be managed more efficiently, with less duplication.
- Use of paper in the study can be reduced, with environmental and storage benefits.
- Systems can be accessed remotely, particularly important as more people are working from home.
- System access can be more tightly regulated, enhancing protection of patient data.
- Study records can be monitored remotely, removing the need for travel.
- Removes the need to spend time printing and filing study documents.
- Study documents can be easily circulated to participating sites and acknowledgement of documents recorded remotely.
The Bristol Trials Centre (BTC) is a UK based Clinical Trials Unit (CTU), which has successfully used an in-house designed electronic study management system in a number of multi-centre trials. This system includes:
- The trial master site file, containing all generic study documents.
- Local site files for each participating site, managed by that site and allowing for remote monitoring.
- The study delegation log.
- A link to the study database.
More information on the system can be found by watching this presentation from the 2020 Trial Methodology Research Partnership webinar series.
The Mango Study Management System
Following the growing interest in electronic study management systems, the BTC applied for NIHR CTU Support Funding to develop a generic system as part of a call for projects supporting efficient and innovative delivery of NIHR research. This successful application was made in collaboration with Peninsula CTU, the Pragmatic Clinical Trials Unit at the London School of Medicine and Dentistry, the Clinical Trial Service Unit at the University of Oxford, the MRC Clinical Trials Unit at UCL and York Trials Unit.
This has led to the development of the Mango Study Management System, a generic online solution which will be available to UK based CTUs at minimal cost to facilitate management of clinical trials. The specification for the system is currently being finalised alongside the project collaborators, but key functionality will include:
- Accessibility: the system will be optimised for use on computers, mobile phones and tablets.
- Security: patient identifiable data will be protected, with all access requests overseen by local site Principal Investigators.
- Ease of use: the system will require minimal training for CTUs and site staff, and minimal ongoing support.
- Integration: the system will be able to interface with a range of patient database systems, e.g. RedCap.
- Inspection: the system will create a full audit trail and regular back-ups, as well as allowing view-only access for monitoring visits and inspections.
- Generalisable: the system will be suitable for use with numerous clinical trial designs, e.g. blinded, drug trial, device study.
- Archiving: the system will be archived and will allow sites to archive their own local site files, as required.
- Configurable: the system can be adapted to suit the needs of different CTUs and trials.
- Validated: the system will be rigorously tested.
- Capable: the system will be able to facilitate management of large multi-centre trials.
An overview of the system can be viewed here.
A report summarising the development process and next steps for the MANGO Study Management System can be found here.
Stay in touch
You can follow the progress of the Mango system development on this page, and by following us on Twitter @MangoStudyMS. If you would like more information, please contact the Mango team at firstname.lastname@example.org