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The perspective of the trial database programmers: discovering their role and how this relates to SITU

Lucy Eldridge: Senior Database Officer

I’ve been working for OCTRU as the Senior Database Officer (DBO) for several years, which primarily involves building clinical databases for trial teams, along with providing user support for the IT systems we offer. I also oversee our two Database Officers (we form the snazzily named ‘Team Database’) as we work together to provide a range of programming and support services to 40+ trials. Fun fact – I’m not actually a ‘computer programmer’ (at least, not in the traditional sense!); I graduated with a multidisciplinary science degree and fell into this line of work. It was a happy accident - I’ve never looked back!

At any given time I have a number of trial database builds on the go; for SITU, I’m currently working on PART, NKP1, and FUTURE-GB, having recently finished FUTURE-GB IDEAL and PASHiOn. The structure of my day will depend on what comes into our virtual ticketing support system (‘Mantis’), but as the senior DBO, my day-to-day work is largely concentrated on builds, amendments, and supporting the rest of the team. Throw in a few meetings, emails, and a lot of paperwork, and the day is over before I know it!

In terms of what a build involves, I use REDCap to create online forms and questionnaires (the front end of the clinical database), following specifications from the trial team. Some of these forms will be for site staff/clinicians to complete as a patient progresses through the trial; others will be completed by the patient directly, and according to which category they fall into (most trials have a mix of both), I’ll need to tie questionnaires together and schedule email invitations and reminders. I also have to set up a randomisation system to enrol patients, and connect this with REDCap.

The aim is to create a slick interface for all users that satisfies our stakeholders. The data entered into the forms we create needs to be of the highest possible quality for the Trial Statisticians to be able to do robust analyses, so we use standardised coding where possible, and automate what we can for accuracy. We need to think about the Data Management teams who’ll track and query data as the trial progresses, and we’ll also make certain everything is in place to satisfy our SOPs and the Quality Assurance team. Of course crucially, we must ensure that everything we build is as user-friendly as possible for site staff and patients. The DBO role in a database build can become a bit of a balancing act to keep everyone happy, but there’s room in there to devise innovative solutions, and that’s the part of the job I enjoy the most.

I like working with the SITU team because they share a really positive approach when it comes to database builds. Ultimately I want to create the best databases I can, and the SITU trial teams are always supportive of me as I strive for this, even if it means providing me with more information, or giving me a little extra time to experiment or mock something up. I’ve also found the Data Managers to be really helpful, and keen to engage and learn more about our systems in anticipation of future projects. It all feeds into great working atmosphere for each build, and the positivity extends beyond programming; the SITU team are very friendly people, and easy to get along with.

Charlotte Drodge: OCTRU DATABASE OFFICER

I work in the Oxford Clinical Trials Research Unit as a Database Officer. There are currently 3 database officers on the Programming team, and our primary role is to build and maintain clinical trial databases for OCTRU trials. My workload is currently split between building new trial databases and managing RRAMP users (RRAMP is the randomisation system used for OCTRU trials).

I’m not currently building any databases for the SITU team, however, I used to work as a Clinical Trials Assistant on the SITU Team, and they are incredibly friendly and open - whatever question you may have, someone will have the answer. They are great to work with, and be with (at least when we were in the office!)

MALCOLM HART – OCTRU Database Officer

I joined OCTRU in 2018, and work as part of ‘Team Database’ (along with Lucy and Charlotte) as a Database Officer. I’m jointly responsible for building new clinical databases and updating existing ones, plus all the technical and user support that goes with maintaining and running our numerous IT systems.

I started out as a psychologist but gradually morphed into an IT support specialist (via an MSc in what we now call A.I.) and have worked at Middlesex University; the Institute of Psychiatry, Psychology and Neuroscience (IoPPN) in London; and at Yale University Medical School, interspersed with spells as a bookseller and a climbing shop manager. I then spent a few years in the public sector before gratefully finding my way back into academia at Oxford.

When building a clinical database, I think that it’s of the greatest importance that as well as accurately collecting the data required, the questionnaires and surveys that we write (particularly those that will be seen by patients and their relatives) should be top-notch in terms of appearance, readability and ease of use. A questionnaire that looks terrible will not inspire any confidence in the patients and proxies who will ultimately complete it. I’d like to think that attention to that sort of detail is one of my key skills.

I have worked on a number of SITU trials – most recently PRoCuRe – and am about to embark on another for DISCUS, which I’m looking forward to. I really do enjoy working with the SITU team; it seems to me that – as well as being a friendly and approachable bunch – they have similar goals to mine and are always happy to discuss and tweak a project if it will improve the end result. Their patience with this sometimes lengthy process is always appreciated. I also admire the way that the SITU team members support each other – it all adds up to a very positive experience.