clinical informatics research unit

Update from Dave Osler

 
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Well it is safe to say that the last few months have been somewhat eventful to say the least. The GDPR D-day has been and gone along with so much work happening across the NHS and academia to prepare for. It certainly feels like everyone has a better understanding of their data now and are more conscious about how it’s justified, where it’s stored, how long for, who the data controller is, alongside all the other stipulations and requirements of the regulations.

Clinical research data capture has for a long time been highly regulated and controlled due to the many other directives and frameworks under which we operate meaning that we should all have been in a fairly strong position to steer ourselves to GDPR compliance. As one University said to me ‘it’s not clinical research we are worried about so much, it’s research across other faculties’. This is where we come to realise that outside the sphere of clinical research, not all protocols include the basics such as a data management plan.

In line with our dedication to high quality research management, every member of the EDGE team from developers to account managers, Head of Operations to our directors PA have completed their GCP training alongside mandatory GDPR training.

We are starting to develop the next stage of the EDGE – CPMS interface called ‘SetStudySites’. This will transfer project sites from EDGE in order to create those site records on CPMS, therefore reducing the need to enter the same site data on 2 separate systems. This will lead us gradually towards our shared vision of a truly integrated research system.

Blog post written by Dave Osler
Head of EDGE Knowledge, CIRU

University of Southampton

My experience before joining CIRU

 
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My experience within research has been relatively short but a varied one up to this point. I have gained unique experiences and have learnt much about research over the last 4 years. Not only is research an extremely rewarding practice to be a part of but our governments drive for the UK to lead in research for patient care and economic growth also makes for a gratified career prospect.

I first got into research after working for 9 years within many different Pharmacy departments at Southampton General Hospital. Being well aware the step up to a Pharmacy technician wasn’t for me, I knew it was time to take another route. At that time I took an opportunity within the Clinical Trials Pharmacy department as a Senior Clinical Trials Assistant. Dispensing trial drugs and accountability were key aspects of my day to day duties within that role as well as ensuring nurses received their prescription drugs on time for their patient’s appointments. Due to the importance of time windows within most CTIMP protocols, each dispensing item had a time limit from receiving the script to a final technician check. This could be very stressful at times when the pharmacy was extremely busy and as most prescriptions were not presented in advance this could not be predicted. Other essential tasks involved recouping costings from commercial studies by collating finance figures from site file accountability logs. This was very important as our department mostly relied on funding coming in from commercial trials.

After 6 months I was employed as a ‘Pharmacy Clinical Trials Co-ordinator’, an extremely rewarding role where I was solely responsible for over a million pounds worth of trial medication. Good relations and communication with PI’s, Co-Investigators and Nurses were pivotal for preparing CTIMP deliveries and prescriptions, enabling chemotherapy and other trial IVs to be made in the aseptic’s in time for patient’s appointments. As IVs all have various expiries (once made) it’s imperative my organisation skills were on point. Some medication can quickly expire, wasting thousands of pounds of stock while also holding up a treatment chair in a busy cancer clinic, in turn wasting pharmacy and research teams’ valuable time.

With a taste of research I felt it was the right time to move away from Pharmacy after 10 years and I joined the Lung Research team within the same hospital. A small team of 5 (Including myself), consisting of 2 senior nurses and 3 research assistants.

My time was split supporting senior nurses with administration duties such as updating trial site files and inputting data into ECRFs after patient visits, while the other half was assisting in coordinating 100,000 genomes project implementation into the trust. Along with this I also gained consent from patients for the TargetLung study. This would entail following patients through their standard of care journey, taking their bloods and processing bodily fluids in a lab for scientists to process. I would also collect tumour tissues from many different procedures in order to help researchers try and improve their knowledge of how the immune system works with lung diseases. As you can imagine this was an extremely insightful way of learning how laboratories, theatres and various departments work together in research.

With the above hands on experience of clinical trials on my side, it has assisted me a great deal as a Knowledge Officer at the Clinical Informatics Research Unit, in understanding what clinical research teams need to carry out their occupations effectively. The CIRU team has a great diversity of experience from all aspects of research departments which helps us solve problems and brainstorm issues efficiently with good understanding of our users. Naturally there are times when issues arise where we are not familiar, but good relationships with CRNs and the Trusts keeps the CIRU team up to date with current affairs which is helpful for running the EDGE programme.

Blog post written by Lee Pearce,
EDGE Knowledge Officer, CIRU
University of Southampton

Clinical Informatics Research Unit Update

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We would like to take this opportunity to give you all an update on what is happening here at the Clinical Informatics Research Unit (CIRU). 

We would like to warmly welcome Dr Mike Head and Dr Rebecca Brown into the department. They are both Research Fellows at the University of Southampton and are currently running the ResIn study.

The Research Investments in Global Health study (ResIn) is funded by the Bill & Melinda Gates Foundation. The project previously focused on the UK research landscape and published widely on the strengths and gaps in the UK research portfolio for both infectious diseases and oncology. Levels of investment have been compared to global and national burdens of disease to gain an insight into relative levels of spend and inform priority-setting initiatives. Now, ResIn is building a global dataset and analysing funding trends and disease burdens for infectious disease research across the G20 nations and will report findings in 2018. The study, and results to date, have been presented multiple times to many high-level global health stakeholders including the World Health Organisation, European Commission and the Wellcome Trust. Findings have also been cited by others in numerous documents including journal publications and government reports.

See http://researchinvestments.org/ for more about the project.

Written by Dave Osler, Head of Knowledge, CIRU