Update from Dave Osler

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.

The Juravinski Cancer Centre – The Workflow of a New Study by Bianca Bier

A study is presented to the Juravinski Cancer Centre (JCC) Clinical Trials Department (CTD) – it could be presented by an investigator, an academic co-operative group, or a commercial sponsor – but how does it make its way into EDGE and what happens to it along the way?

Once a study is presented to the CTD, it is entered into EDGE by one of our Trial Activation Coordinators. All of the pertinent project and site level information goes in, as well as some site specific Attributes (e.g. research team assignment, specific dates and comments, etc). The study is booked to a Protocol Review Committee (PRC) meeting where the PI discusses the scientific merit of the study and resources required. Documents are posted into the site Files in EDGE for all to view and use to prepare for the meeting. Meeting dates are logged in EDGE in Attributes. Once the committee approves the study to move forward, the study moves to being “in set up” in EDGE and investigators and the research team can track the activation process and recruitment metrics through Shared Reports.

During activation, the Trial Activation Coordinator ensures all of the current approved regulatory documents are uploaded to EDGE and enters trial activation milestones into Attributes. A simple contract Attribute is used to track the contracts process from review to execution, and well as a finance Attribute to track per-case funding (if applicable). As the majority of our studies involve drugs, our Clinical Trials Pharmacy Team tracks their activation and amendment processes in Attributes. Other impacted departments use EDGE to reference protocols to create their internal procedures or view Shared Reports regarding utilization of resources.

Once activated, the study then transfers to the Clinical Research Coordinator (CRC), who is responsible for entering their patients into EDGE and for working in tandem with the assignment Clinical Research Associate (CRA) to ensure their patient statuses are up-to-date. CRCs and CRAs are frequently in EDGE to look up protocols, print consent forms, view study assignments, and book monitoring visits. They also work closely with the assigned Ethics Secretary who submits all post initial approval REB submission (e.g. amendments, annuals, etc), tracks this information in EDGE site Workflows, and uploads approvals and regulatory documents into site Files. Finance is able to track start-up costs and use the information entered in Workflows, Attributes, and the patient status workflow to determine payments. Investigators are in EDGE more and more as we have made EDGE our sharepoint for our current open trials via Shared Reports. As a study winds down, the CRC is in contact with our EDGE Lead Admin and the assigned Ethics Secretary to close out the study.

With all of these separate users working together, we are able to pull extremely detailed reports, which are circulated to management, senior leadership, investigators, and staff to keep everyone informed of the good work happening in the CTD. We merge EDGE reports with reports from our electronic medical record to create an even broader picture involving both the regulatory workload and the clinical workload associated with a study. The information is distributed regularly via email through dashboards, newsletters, and raw data, and is also posted in a special Investigator and Staff file area in General Documents.

We highly promote idea sharing and collaboration and we are very involved with our fellow Canadian EDGE sites (as well as our UK friends!). We look forward to rolling out new functionality around the Finance tab, tracking of CRF data entry to ensure timeliness of data submissions, tracking of training certifications, developing a patient level tracking system for lab specimens, and further refining our use of EDGE.

Blog post written by Bianca Bier
Network Coordinator, JCC

Identification of CTIMP studies in EDGE by CRN West Midlands

In the CRN West Midlands, the Research Pharmacy community has been working together towards integrating EDGE into their working practices. This includes activities such as workflows and attributes to enable the collection and reporting of data. In order to allow pharmacy involvement at the earliest opportunity (for the collection of study start up data) and to enable the inclusion of all pharmacy data in reports, it is important that these studies are identified as a CTIMP. 

Currently, trying to ensure that all CTIMP studies can be identified is a lengthy process of checking multiple data fields that may apply to this type of study and there is no guarantee that all studies of this type can be identified.

In an effort to resolve this issue, we would like to ask that the CTIMP Yes/No data field (on the main project details page) is completed by R&D /Commercial teams when adding a study onto EDGE.

If EDGE users notice this information is missing, we would like to ask that they contact the owner of the study to ask that this information is completed- thank you. 

Blog post written by CRN West Midlands
 

My experience before joining CIRU

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

A week of Pharmacy and EDGE by Emma Fleck

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

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