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ExploreWe successfully digitised a paper-based Government clinical research agency, while following GDS best practice.
About CPRD
The Clinical Practice Research Datalink (CPRD) supports real-world clinical research through innovative use of electronic health records. Anonymised health records from over 30 million UK patients, collected by the CPRD for almost 30 years, provide a historical database for clinical research.
This data is used by academics, regulators, and the pharmaceutical industry worldwide for public health research purposes only.
As part of the Medicines and Healthcare products Regulatory Agency (MHRA), the CPRD has been providing anonymised primary care records for public health research since 1987. Research using CPRD data has resulted in over 1,500 publications which have led to improvements in drug safety, best practice, and clinical guidelines.
The CRPD wanted to streamline the Independent Scientific Advisory Committee (ISAC) application process. As a result of winning an open tender process via the G-Cloud portal, Reading Room was appointed to undertake the project.
From day one, the CPRD required our team to follow GDS best practice. Building upon its internal discovery work, we performed a Discovery plus phase, to validate CRPD’s outputs. This was followed by an Alpha prototyping phase, which lead to public and private Beta phases.
In order to meet the primary aim of the project, we enabled:
- Researchers to submit ISAC applications via an online interface. They could follow their application through the process, view its current stage, determine when a response might be received or when to chase the ISAC team
- The CPRD-ISAC team to process applications more effectively within one system (rather than using a combination of Outlook, spreadsheets, and Salesforce), and ensure all stages of the process are completed within specified timelines
- The ISAC panel and internal reviewers to manage the applications they need to review more efficiently and reduce the time required to complete the process
Our team helped the CPRD bring together findings from its internal Discovery, and ran a Discovery plus phase to distil these into a set of recommendations.
The Discovery comprised three key stakeholder groups:
- Clients – external users of CPRD data from Pharmaceuticals and Research teams
- ISAC – the ISAC panel
- 3Internal – CPRD reviewers
After conducting the stakeholder research, our specialists identified a series of technical challenges. These included:
- A complex set of governance and data security processes
- A robust and detailed review process that needed to be digitised
- Complex logic and gating for the different stages of the application process
- Integrations with Salesforce CRM to securely hold user data
A common thread across the discovery work was the degree to which knowledge in the process was siloed with key individuals.
“Nobody knew what the end-to-end process was until we process mapped it with Reading Room. Until then parts of it only existed in different people’s heads.”
Approach
We worked with the CPRD team to make sure GDS standards were followed throughout the process, ensuring that the project was informed by user needs and followed service design methodology.
As part of a technical review, we investigated the systems behind the current service and the key points of integration. This gave our team a technical understanding to gather nonfunctional requirements. We also created a delivery plan that considered how the existing service would be maintained, and how applications would be transitioned to the new platform.
The output from Discovery was:
- Backlog of prioritised user requirements
- Roadmap of functionality (to be included in Alpha, Beta, and beyond)
- Scope of work
- Budget expectations
- Timeline for development
- Technical recommendations for both CMS and hosting architecture
Another key finding was the original system had no single point of truth with regards to data. It was imperative going forward for Salesforce to become the single point of truth and have close integration with the new electronic research applications portal (eRAP) system. This integration required a bi-directional API that allowed the eRAP system to pull on data to autofill forms and for eRAP to update Salesforce records.
Discovery highlighted the need to test specific features in alpha and refine them for delivery during the beta phase. These features include:
- Complex review process - it was imperative the eRAP system allowed all the users/stakeholders to know exactly where a protocol was in the process, and to let them know when there was a task or action required by them
- Roles and permissions - it was important to make the roles and responsibilities flexible, but stringent enough that permissions didn’t change what can be reviewed and seen
- Bespoke workflow - allowing for resubmission and additional review
- Form navigation - with over 60 fields, there was a need to provide user navigation hints and tips to allow them to move around the section and review inputs before final submission
- Form validation - intelligent ‘as you type’ checks so basic errors were picked up and could be corrected by users
- Exposure of fields - the user only sees what they need to see depending on their inputs
By following GDS best practice, the complexities of the project were flushed out early. This meant that onward phases allowed rigorous user testing and prototyping to evolve the eRAP system before the first launch.
Outcomes
The rigorous Alpha and Beta testing phases of this project (pre-live) resulted in a first release that exceeded the CPRD’s expectations for the MVP. Following an agile delivery process, the CPRD was in control of its product backlog, allowing it to meet its tight timescales with confidence.
The MVP was launched successfully with immediate user uptake and positive feedback from both applicants and ISAC reviewers.
Along the way, the CRPD was able to incorporate learning into a backlog of enhancements, allowing it to progress into a new phase of platform development.
Delighted with our work after the MVP launch, our relationship has continued into ongoing feature development, service, and maintenance of the platform.