By Carolyn Maloney
Clinical services have historically captured information about potentially research-interested participants from patient clinics. This data is often entered into Excel spreadsheets, with consent forms stored separately on other drives. The information is restricted and only accessible by people with legitimate access to shared drives (good), but can only be accessed when on a Trust computer system (bad).
We were approached by the National Institute for Health Research (NIHR) Clinical Research Network (CRN) East Midlands (EM) data team to explore the potential use of the Business Intelligence tool, EDGE, as an alternative solution. Here’s what we did and why.
EDGE is secure, accessible, easy to generate reports from, and has the capacity for consent forms to be stored. Information collected can be unique to each individual area, specialty, or consultant and can be adapted and added to as required. Every ‘dataset’ can be bespoke for each clinical area.
Benefits of using this system
Each patient consents to being added to the ‘Pre-consent’ database. The consent forms are held with the patient information, as opposed to separate locations, and can be viewed in real time. Access to the system is restricted and only individuals with legitimate access can be added to view the system.
The system is cloud based which makes it accessible wherever there is WiFi. The consultant can access the information and provide an intelligent assessment when conducting a feasibility for new research studies. Patients who have expressed a previous interest in clinical trials can be contacted directly and invited to participate in research studies.
Progress to date and next steps
The first example is up and running in a specialty area and the team are presenting on their experience at an event in November. We’re able to roll it out across our Trust to anyone who wants to develop their own ‘Pre-consent Database’. If you’ve already got a dataset in Excel we can transfer it into EDGE – no need for lengthy manual data entry!
For more information about pre-consent databases, contact Carolyn Maloney.
Carolyn Maloney is Head of Research Operations at Leicester’s Hospitals.