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Innovation in the Management of Clinical Data Award 2021: Joint Winners

PHASTAR Data Operations

PHASTAR data scientists and data mangers have worked closely together to develop a novel AI and rule based approach for the production of auto-generated queries to identify potential data issues and inconsistencies in clinical trial data. The PHASTAR team have integrated the role of the human expert with intelligent process automation through a targeted approach. They are able to discover hotspots of data quality issues on studies through the application of AI (NLP) approaches to the meta data, identifying problematic forms and variables. They are now building labelled data sets to which machine learning methods maybe applied.

AstraZeneca RALPH team

While working on vaccines there was a need to code free text for adverse events. The team built a GXP compliant machine learning tool to review the free text and pick out the terms that should then be loaded into the coding tool. This resulted in many manual hours being saved and AZ being able to respond in a timely manner to the HA

Innovation in the Management of Clinical Data Award 2021: Runners Up

Derby Clinical Trials Support Unit

The DCTSU Power BI team are nominated for the outstanding initiative on streamlining and automating a lengthy and complex process about the development and presentation of the Central Monitoring and the TMG / TSC reports. They have created a Microsoft Power BI dashboard which is used for all active studies and as a template for future studies. The process has been complex prior to this initiative as multiple DCTSU staff (data managers, statisticians, trial managers) were involved in the development of the Central monitoring, TMG, and TSC reports. The data were extracted monthly from the EDC system and multiple data formatting was taking place in MS EXCEL by the data manager and the trial manager separately, before the data were in the appropriate format for constructing these reports. The trial manager was, then, following a lengthy process to create and maintain every month these reports using tables and graphs in MS EXCEL with support from the statistician and the data manager.

Individual Excellence in the Management of Clinical Data Award 2021: Winner

Sarah Huggett

Sarah has led an initiative implement Value Driven Data Cleaning principles at GSK aligning the data cleaning strategy with critical to quality data designations, thereby focussing on the data that matters. The initial impact of Value Driven Data Cleaning is to focus data cleaning efforts on the data points that are critical to the study and prompt multi-disciplinary study teams to reduce checking (and collection) of non-critical data. The longer term impact is expected to be a reduction in data collection. Risk based methodologies are applied to the data cleaning strategy to ensure that data cleaning approaches for critical data are interrogated appropriately in order to identify and mitigate risks. Non-critical data are subject to reduced data cleaning i.e.; reducing low value queries and thereby reducing the burden on site staff, monitors and data management.

Individual Excellence in the Management of Clinical Data Award 2021: Runner Up

Tracey Lavery

Tracey has been a member of the eDigital team for 2 years and the lead author on no less than three content pieces, which have been a great source of guidance and knowledge to our community. She is an valued contributor to the team and it is a pleasure to work with her.

The first two outputs which Tracey made for our group were on the role of a data manager and how it has changed. This enabled our community to understand the type of responsibilities that are attributed to each title and what skill sets they can work on in order to progress their careers.

The third is a collection of our team’s discussion on electronic health record integration, which is a thought leadership piece  to help set the tone for future reflection or position papers on whether we believe our industry is ready to take on the challenge of incorporating this data at large.

Team Excellence in the Management of Clinical Data Award 2021: Winners

EDGE team (University of Southampton) & the UHS R&D team (University Hospital Southampton)

The Research and Development (R&D) team at University Hospital Southampton (UHS) has developed an innovative approach to support remote monitoring during the coronavirus pandemic. This has been achieved through the use of the EDGE Programme, which is our units cloud-based clinical trials management system. The UHS R&D team has developed a new approach which allows sponsors to access trial information remotely. This has led to limiting the need for sponsors to visit the site in person which was proving a challenge at the start of the pandemic.

The team at UHS includes Mikayala King, Felicity Gibbons and Kim Lee who have worked closely with our EDGE team in getting this off the ground. In order to use EDGE in this way a lot of work has gone into it especially from UHS’s side. This includes having to validate the new process and ensure that their Information Governance and Information Security teams were happy. The team had to go through quite a process finding out what the issues were and then finding workarounds and solutions. I believe they should be recognised for their hard work, dedication and time on this, especially whilst working through a pandemic which already brought extra stress and workload to their R&D department

Team Excellence in the Management of Clinical Data Award 2021: Runner Up

DATACLin Clinical Data Management Team

DataClin are the first Egyptian CRO with a 100% females team in the middle east to implement EDC in our region, with no outsourcing tool or highly expensive software, they provide the highest quality with the minimum cost to support the middle east region to work with EDC and to shift from paper CRF.

DataClin initially struggled on delivering the highest quality of data management with the least cost. Unlike other CROs working till now with paper CRF, so the Team had to be creative and not to accept to work with minimum technology , they worked so hard to have a good quality system to include all the required steps and to learned to use this high technology by themselves to minimize the cost of EDC outsourcing/build , to be able to enforce the research field to use this technology.

DataClin started their journey in 2015 in implementing EDC, and worked with several opensource system, it was a very big challenge to learn to handle the system by themselves. The team not only perform data management activities, but also create studies, edit checks and every single step on the EDC till the study in cleaned and ready for analysis.

DataClin’s work appeared during COVID19 pandemic, due to lockdown, most of the paper studies stopped and most of the local CRO closed for a while, but the Team completed their work either in Egypt or in the region, the whole team completed all the requested study due to the initiative and innovative steps taken, and helped a lot of sponsors in the MENA to perform there studies using EDC.

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