Exploration of EDGE Functionality


Our use of technology and the role it plays in our lives is increasing, both in and out of the workplace, with it even reaching levels of addiction in some instances, case in point where the World Health Organisations now includes a classification of ‘Gaming Disorder’ in their new International Classification of Disease (ICD-11). 

This raises an important question about how effectively we use technology and how that technology benefits us in return, especially within the workplace where most often the technology is provided to us, rather than being chosen by us. The Health Secretary Matt Hancock is a big advocate of digital technology and has already expressed a strong desire to unlock its full potential in the NHS, after describing it as the “worlds most frustrating place to work for its IT” at the Health and Care Innovation Expo in Manchester. 

Here in the Clinical Informatics Research Unit, our Knowledge Officers spend a lot of time working with hospitals and research organisations to ensure that the systems they use provide them with maximum benefit, helping them to understand the full range of functions available. This includes how they can utilize it in different ways in order to streamline processes and improve operational efficiencies, or in layman’s terms just making it more useful and helpful. 

Every organization uses the system differently, and subsequently every organisation will experience different benefits. This is not to say that the system is different between organisations, it is after all the same system, instead it is down to the heterogeneity of each organisation, notably which other systems are already being used, and how, in this case, EDGE has been implemented. 

Part of what we do as a team, and as a community is to share best practice and we see this in so many different areas, most recently with primary care and pharmacy groups being created, and this cooperative working is not limited to the NHS. Colleagues using EDGE from Canada are just as willing to share their work and are just as receptive to the innovations from the UK because, lets face it, we are all trying to provide the best environment and best infrastructure to provide opportunities for patients to take part in research. 

Something that I have noticed on my travels is that there are sometimes functions in EDGE that people didn’t realise were there, or maybe didn’t see how they could really benefit them. This is where I intend to offer out some advice on different aspects of how the system can be used over the next few months, to ensure that people can make the most of the system and ultimately to make sure that the technology is effective, is benefiting peoples work and ultimately reduces the view that the NHS, or other healthcare providers are ‘frustrating places to work for its IT’. 

In this first instalment, I bring some work from Gaurika Kapoor, Operations Manager at Alder Hey Clinical Research Facility, in which she has created an Entity on EDGE for the purposes of collecting data for their NIHR CRF Annual Reports. This is going to be used to standardise their approach to capturing the information and providing a central place for reporting. 

This has now been published into the Global Library, for all EDGE Admins to download if they so wish and can be found on EDGE by going to LIBRARY > ENTITIES > ADD GLOBAL ENTITY > click ‘CRF’. 

Once you click on it a copy will be downloaded into your library, allowing you to add, edit or delete sections in order to use it for your own data collection requirements. *And just to clarify, changing your version of it will not affect anyone else’s copy. 

There are many other Entities available in this library which have been shared by organisations who believe they would be useful to others, so go and check it out and see if anything you like. On a side note, over time this library has become quite busy, so I will add a ‘to do’ to my list and see if we can clean this up a bit. 

Thanks for reading and keep watching out for the next series, where I will go into more depth around other functions that you could use in EDGE.

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

Looking for inspiration for your next Power BI Report?

Microsoft Power BI

Microsoft has a growing community of users all across the globe. There are accomplished users within the community that are enthusiastic to show off the data analysis and report designs that they have created. Some of these reports are held in the Data Stories Gallery on Microsoft’s website, found here.

Within this Data Stories Gallery, you will find all sorts of different reports based on topics as far reaching as the North Korean missile capability to cheerier subjects such as the World Cup. Whilst the topic areas might not be strictly Clinical Research or even Healthcare, the reports demonstrate the wide array of methods of visualising data that are available to users.

If you wanted to take a look at how the reports are set up e.g. what visualisations are actually used, which fields go where, or what formatting has been used, you will find quite often that the author of the report has shared the Power BI file (.pbix file) in the description. You are able to download this file and open it in your Power BI Desktop application.

If any of these Power BI reports inspire you and you would like to share what you have created with the growing community of EDGE users using Power BI, please send an email to me at: p.oxford@soton.ac.uk.  We would love to supply the pedestal for talented users to demonstrate their skills and ultimately if the report is useful for you, there is a very good chance it will be useful for others in the EDGE community!

Blog post written by Pat Oxford,
Data Analyst & Knowledge Support, CIRU
University of Southampton

Utilising EDGE to Record, Monitor and Report on Studies Supported through the NIHR CRN West Midlands Early Contact Service


Data has never enthralled me but I understand the importance of capturing and recording accurate data in a timely manner to create a clear picture of how a service is performing and to install the confidence to then disseminate report findings to a wide audience. Plus my line manager is a data enthusiast so data accuracy is of paramount importance to ensure meaningful analysis and this is regularly communicated to the team.

My role is to manage the Early Contact service for the Clinical Research Network West Midlands. The Early Contact service supports Chief Investigators and their research team as early as the research idea stage and up until study set-up at key stages across the research delivery pathway. The team is made up of 12 Early Contact Leads who each have a caseload of up to 30 clinical trials that they are providing support for at any one time. Therefore, it is important to be able to maintain a record of each study, monitor progress at key stages, and provide accurate reporting on the service.

Prior to the use of EDGE, the CRN West Midlands Early Contact team were using an ever growing Excel spreadsheet to record all studies supported through the Early Contact service. This was becoming cumbersome with multi-user editing, data errors and speed issues to name a few of the challenges that made it difficult as a manager to maintain oversight of the service and have confidence in the accuracy of data. Not being a fan of spreadsheets or a data driven enthusiast, data management was becoming a dull routine that I was keen to change!

Once EDGE was introduced to the Network, it seemed the perfect solution to adopt and the Early Contact team have used the functionality of EDGE to make it specific to the team’s requirements for recording, monitoring and reporting on all Early Contact studies. As a team we were glad to see the back of the monster spreadsheet and embrace a new concept more suitable to our needs.

The use of EDGE has been a learning curve as it was new to the team initially and therefore quite challenging to learn how to use a new system as well as ensure the functionality had been explored and utilised to our advantage. A five step approach was adopted for rolling out the use of EDGE in the Early Contact service:

  1. Identify EDGE attributes specific to the  requirements of the Early Contact service

  2. Develop an EDGE Early Contact User Guide (and adapt with every changing requirement!)

  3. Train Early Contact Leads in use of EDGE

  4. Update EDGE attributes and Guide as necessary and communicate changes

  5. Monitor success of use of EDGE for Early Contact service (this was an easy one!)

As a result of utilising EDGE for the Early Contact service (compared to the previous clunky spreadsheet system), more accurate data has been achieved more easily and a considerable amount of time has been saved too (always a bonus!). The Early Contact team have also experienced the following benefits:

  • Production of more accurate and timely reporting (2 hours time saved in producing a monthly report)

  • Easier identification of capacity for Early Contact Leads to support more studies (over 2 hours time saved in producing workload reports)

  • Assurance that more accurate study records are produced and maintained due to mandatory attributes being set up specifically for the Early Contact service

  • Ability to add attributes to address changing requirements and reporting needs

  • Additional functionality of workflows to monitor progress of studies across the research delivery pathway

  • A more satisfied line manager (our data enthusiast) at these results!

In summary, EDGE has given the CRN West Midlands Early Contact team the ability to streamline current processes, ensure more accurate study records are maintained, and instill confidence in the data produced. As a team we are still chased for any data gaps and you can almost hear the groan in the office as the monthly data gaps email gets circulated! However, we have processes in place to rectify missing data to ensure the complete picture is captured.

It is inevitable that there will be changing requirements and reporting needs but EDGE currently gives us the ability to capture the data needs and stay agile to support future change.

Blog by Dr. Kirsty Hunter
Research Support Manager
CRN West Midlands

Update from Dave Osler

Dave Osler.jpg

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

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

Juravinski Cancer Centre

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