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

A week of Pharmacy and EDGE by Emma Fleck

Emma Fleck, Salisbury Hospital

The EDGE conference 2018 really helped me to understand what this software has to offer. Listening to how different organisations find new and innovative ways to use EDGE was exciting. It’s also promising for the development of EDGE in conjunction with our local processes. However, when asked to write a blog for EDGE, I decided to focus on what I am currently using the system for in our pharmacy. I wanted to capture a week of EDGE use in pharmacy at Salisbury Hospital.

So, what have I used EDGE for this week?

I (very nervously) described in my presentation at the EDGE conference about how we are using patient appointment reports to anticipate trial prescriptions and improve the patient’s journey. After a week’s annual leave, I returned to work and updated the patient appointment report for the week ahead. Using this information I was able to request prescriptions in advance for one of our trials. This improves the patient’s experience as, after all, no one likes waiting in any pharmacy for their prescriptions. It also reduces the amount of urgent work for the dispensary.  By using EDGE in this way and requesting the prescriptions, a communication channel was created with the research team in which I could feed back how smoothly the dispensary team found the first cohort of repeat dispensing for this trial.

We got the green light for an ENT trial this week. I logged on to EDGE and completed the pharmacy work flow to indicate to the research team that pharmacy were green for go. I could also ensure we were opening to the correct version of the protocol by checking which version had been published by the research team on EDGE.

I updated the work flow of a trial in set up. We are now looking to arrange the SIV so wanted to make sure I had completed all that I could. I took this opportunity to add notes to the work flow so the research team could better understand pharmacy involvement (such as own stock used for the IMP).

There was some confusion with patient ID numbers on 2 trial prescriptions that we received in pharmacy. Using EDGE, I could look up the correct ID number, check all other patient details matched and correct the prescription accordingly without taking up the research team’s time and without delaying the patient too much.

These are just a few examples of what we use EDGE for here at Salisbury in the pharmacy. These may be simple tasks but they each save time for all, with EDGE providing a platform to effectively share information between the different teams involved in research. It’s exciting to think how our use will develop in the future, building on its current key role in our communication and service delivery.

Blog post written by Emma Fleck,
Pharmacy Technician, 
Salisbury NHS Foundation Trust

Life as an EDGE admin by Thomas Bower

Tom Bowers using EDGE

Similar to the universe clinical research at University Hospital Southampton (UHS) is continuously expanding, which has ultimately enabled more studies to be conducted here.  To ensure studies are efficient and hit recruitment targets an increase in staff numbers and departments has occurred to meet this demand.

Like clinical research at UHS, EDGE has constantly evolved since being developed by the Clinical Informatics Research Unit within the Faculty of Medicine at the University of Southampton. With such a great number of individuals and departments within UHS utilising such an intelligent research management system, the role of an EDGE champion was created to overcome any issues that may arise because of this. Alongside my job as a Clinical Research Coordinator, I am also an EDGE champion, who are the human and digital assistants of EDGE and direct users to their solution. We achieve this by providing the central support for individuals and enable efficient communication between clinical teams, management, R&D, finance teams, and support departments.

As a local admin we utilise EDGE in numerous ways from monitoring and providing access to individuals for specific studies, to capturing the current status of studies. In addition to this we are required to have knowledge in all areas of EDGE, which enables us to answer all queries that may be asked from a member of staff. This knowledge would cover aspects including, study statistics, requesting involvement to a study, transfer of ownership, document upload, reporting finances, recruitment activity and reports, study timelines, and so on.

The framework and support that has been created by using EDGE has brought people together and has allowed me as a local admin to create relationships across the trust, that enable me to be more efficient not just in using EDGE but in my role as a Clinical Research Coordinator.

Blog post written by Thomas Bower,
Clinical Research Coordinator, 
University Hospital Southampton

Pharmacy departments engagement with EDGE by NIHR CRN West Midlands

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Pharmacy departments in the NIHR Clinical Research Network West Midlands (CRN WM) Partner Organisations submit a set of data points every quarter to the Network relating to their approval and set up times for clinical trials involving investigational medicinal products. This information is used to create a report which shows how the West Midlands pharmacy departments are performing in relation to time to open studies. This information is used both locally and nationally to identify departments that may need additional support and to share best practice. 

Historically, data was not returned by all Trusts and data was often incomplete. This was due to pharmacy departments needing to contact Research and Development (R&D) for 10 of the 14 data points. These requests took time and effort from multiple people which led to the incomplete data return.

The data requested from R&D was already available in EDGE which meant that the data collection by pharmacy departments was duplication of work.

A project to support pharmacy departments’ engagement with EDGE was created, led by the CRN WM Senior Pharmacy Technician. Partner Organisations were asked to put themselves forward to take part in the project pilot which saw pharmacy staff from four NHS Trusts trained to use EDGE to collect their data, supported by experienced EDGE users at their Trust and the CRN WM.

In order to collect the data, a set of attributes was created in EDGE. The same attribute set was used by the pilot Trusts which then allowed the data to be reported on by the Network instead of pharmacy departments having to return data to the CRN WM.

The project pilot has seen the time and resources needed to collect data drastically reduced and the data return is more comprehensive.

Other Partner Organisations in the region are being trained to engage with EDGE and collect the pharmacy data this way.

As a result of this project, a pharmacy working group is being created to identify other ways in which EDGE can be utilised by pharmacy in the delivery of research.

 

Post by Jenny Warmington,
Senior Pharmacy Technician,
NIHR CRN West Midlands

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

A trip to the EDGE office

Visveswaran Mallayan, Leicester NHS Trust

We had Viswin Mallayan, Research and Innovation Information Manager at University Hospitals of Leicester NHS Trust join us in the EDGE office a few months back and we thought we would share his story with you:

"I had the great honour of working with the EDGE team in Southampton last month, where I spent my time sharing and gaining knowledge reporting in EDGE and Microsoft Power BI, as well as presenting two webinars on “'Using EDGE and Microsoft Power BI to provide intelligent reports and improved business decisions” to a Canadian Team and all the UK NHS trusts.

I have been an EDGE user for over 18 months and use the system to capture recruitment data and prepare reports for senior management and clinical management groups. I utilise EDGE in conjunction with Microsoft Power BI to provide intelligent reports and help shape and inform clinical management groups’ decisions.

EDGE is one of the best tools with greater flexibility for the end user. This means we are benefiting as we can use the system as an intelligent data management tool to fully integrate information from all departments to produce meaningful and quality data for outcome analysis.

Leicester’s Hospitals uses Microsoft Power BI as a primary reporting tool for research data and we are working with the EDGE team to make common Microsoft Power BI dashboards where any Trust using Edge can see their performance (similar to open data platform).

Since the EDGE Accelerate conference in March of this year, my colleague Carolyn Maloney has guided around 20 NHS trusts in the UK on how to use EDGE for Clinical Research." 

EDGE Case Study by Helene Jones

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The Lincolnshire Clinical Research Facility facilitates the implementation and management of clinical research for the United Lincolnshire Hospitals Trust across its multiple hospital sites within the large rural county of Lincolnshire in the East Midlands. The research undertaken within the trust encompasses a wide range of therapeutic areas including oncology, haematology, stroke, cardiology, paediatric, dermatology, diabetes, midwifery, ophthalmology, respiratory, anaesthesia, gastroenterology, renal and orthopaedics. The breadth of research disciplines managed by the research facility and the diversity of hospital sites within the trust called for a flexible clinical trials management system to support its continued growth and build upon operational processes. In April 2016 ULHT implemented EDGE across all of its sites providing a fully-integrated data platform for the benefit of clinicians, research nurses, radiologists, pharmacists and other research professionals, supporting their clinical research and providing real-time trial data and business intelligence.

The nature of research in the region is influenced by the diverse needs of a population and healthcare system in the large rural county of Lincolnshire, and Lincoln as one of the fastest growing cities in the UK. The trust needed a system to provide the flexibility to manage differing scales of operations and the requirements of individual units within its organisation but maximise communication, and provide consistent metrics and reporting. One of EDGE’s greatest qualities is its adaptability which makes it so flexible in managing the complexities of clinical trials and the range of contexts in which they are conducted. 

EDGE is an application which is logical and scalable. During the implementation of the CTMS within the organisation we were able to train and roll out the application around the busy work schedules of the research teams and do this in a stepped process by site. The software is user-friendly yet provides powerful functionality and the option to adapt the application, at multiple levels, to meet the needs of the organisation. A core strength of the system is its flexibility for end-user process adaption, allowing individuals and trusts to creatively develop their particular instance. This in turn contributes to the evolution of EDGE through the perspective of sites and researchers who understand evolving operational needs the most and builds benefits for the EDGE community. The developers have cleverly, through the provision of an attribute based system, created an application which is future-proofed and keeps pace with evolving processes. We can build on the global knowledge of users across the UK and beyond in how we can better use data and systems in the delivery of efficient clinical trials. The role out of the system within our Trust has also provided the unanticipated yet immeasurable benefit of engagement with the wider community of EDGE users in delivering research and in sharing best practices, both in terms of the application itself and sharing research ideas in general. 

Within the United Lincolnshire Hospitals Trust we use EDGE to support the setup, feasibility and approval process for studies, track recruitment, manage patient visits, record resource, interventions and inter-disciplinary departmental involvement such as logging studies requiring ECGs, RECIST criteria, all blood sciences requirements etc. We also use EDGE for substantive reporting and monitoring of metrics by maximising the use of core EDGE reports alongside bespoke attribute reporting at a study level, site level and patient level. We are also seeking to develop the system as a trial evaluation tool and workforce management application. 

EDGE has provided ULHT with an IT platform to support its strategic planning and growth, enhancing its reporting, communication and trial management to support enhanced participant engagement and patient outcomes. All this supports the delivery of efficient clinical trials. The following principles demonstrate the benefit of EDGE for individuals, trusts, networks and the NHS.  

EDGE provides; 

1. Complete flexibility to support specific needs of trusts, sites and individuals in managing clinical trials.
2. Creative power for trusts and sites to develop their own instances to meet local needs.
3. an EDGE community who collaborate to collectively evolve the system.
4. a system which is developed through the perspective of the end users who understand their individual needs the most.
5. a robust and secure integrated system and data set for enhancing operational delivery at trust, regional and national levels.

Post by Helene Jones, Research Support Officer
United Lincolnshire Hospitals NHS Foundation Trust

Helene.Jones@ULH.nhs.uk

A blog post from an EDGE user- Using EDGE to manage a complex primary care study

My name is Randeep Basra and I am a Clinical Studies Officer for the Clinical Research Network in North West London. I am part of the delivery team that helps with the setup and support at primary care sites and recruitment of participants for research projects that I am assigned to work on.

One of the projects currently in progress is iHealth-T2D, a multicentre, cluster randomised clinic trial on type 2 diabetes in the South Asian population. The study looks to provide evidence that the implementation of lifestyle modifications and health promotion is clinically effective in reducing the onset of type 2 diabetes in South Asians with central obesity or pre-diabetes compared to usual care. Managing the study has brought on some complex and challenging situations in terms of project management, where communication, organisation and team work has been key to the success we have experienced so far.

This has been helped significantly by the use of EDGE. In the early stages, large amounts of information about the study was kept in a number of places that were not so easy to access and were becoming difficult to manage by the team as a whole. An example of such information was the staff involved and their contact details, information about clinics being run at GP practices and patients recruited, just to name a few. When hearing about EDGE, we felt it could work to solve these issues.

Since then, we haven’t looked back. Once the process of uploading all the information to EDGE had taken place, we found it straightforward to access and the layout easy to navigate. We are able to effortlessly store different pieces of information about the project or primary care sites in one place that everyone can see. For example, I can find a particular recruiting site in a couple of clicks and can access information on how many patients were contacted from a particular site and on what date, when screening clinics are running and how many participants have been recruited so far. The outcome is that everyone is able to look at and maintain up-to-date information about the study from a single place from almost any location at any time.

Knowing that I can add users and have the contact details of any member of staff from any of the 50+ GP practices taking part is reassuring and allows a smooth stream of communication with everyone involved. Personally, the “notes” section is a highlight for me, as being able to communicate updates about an individual site for everyone to see in a free-text box saves time on administration and permits flexibility depending on what information can be stored here. Although it is not necessary to upload patient information to EDGE for our team, I have found using anonymous codes for each patient recruited at GP practices has been a safe and fool-proof way for me to keep an accurate record of how many participants are engaged with the study. Last, but certainly not least, the “project attribute reports” have been wonderful when requiring a snapshot of the study for team meetings and to assess data quality.

This hasn’t just been useful for me the delivery team – other staff who support the delivery team have found it a great way to pull off information from the system when it comes to arranging financial payments or tracking recruitment. In fact, this study was the first we have tried to store financial information on and while this is work in progress, it has been very useful so far. In this way, the whole team can be singing from the same hymn sheet without the need for endless spreadsheets and hard-to-follow email trails.

We would like to give a special thanks to Kaatje and Sean for all the support we have had in making this system work well for the project. We feel the adaptability and brains of the system, as well as the people behind it, are what make it work for us.

 Here is a shot of the team who have all been involved in delivering the study.

Here is a shot of the team who have all been involved in delivering the study.

Post by Randeep Basra, Clinical Studies Officer
CRN North West London
randeep.basra@nihr.ac.uk

Read an article from us

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You can find an article from our director James Batchelor in this months International Clinical Trials magazine. The title of the article is 'Strength through Collaboration', where James promotes research teams coordinating both nationally and internationally, in safely changing routine standards of clinical care to improve patient quality of life. 

This piece can be found here and has been taken from International Clinical Trials May 2017, pages 24-26 © Samedan Ltd

Visit the contents page of the current issue of PMPS here

 

Global Cyber Attack- advice for our users

As you may all be aware, there was a global cyber attack on Friday causing problems across the NHS.

EDGE is hosted at a secure Tier 4 centre at Carelink, one of the highest level of secure centres available. The EDGE service was not impacted by the attack however, as a precaution we decided to temporarily stop access to the EDGE service on Friday evening to allow time for the threat to be better understood and reduce the risk of any impact to the EDGE service. On Saturday morning after further assurances, access to EDGE was resumed.

This was done purely as a precautionary measure.

We would advise that all NHS staff follow the guidance given by their organisation regarding security patches, run windows updates on all machines and continue to keep all computer systems up to date with anti-virus software releases. Further to this we recommend for those trusts who are running Windows XP to contact their IT department to update to Windows 10 as an extra safety precaution.

In general please can all users be extra vigilant when opening emails and do not open any attachments or click on any links if you are not expecting communication from the sender. Malicious emails may appear to come from other NHS employees, so even if you recognise the sender please do not assume that the contents are safe. If you think your computer has been infected by a virus we advise that you immediately disconnect it from the network or shut it down and contact your IT department.

This is also good advice for your personal computers to limit the impact of these cyber attacks.

We will continue to monitor the situation and react appropriately to continue to provide a safe and reliable service.