BOSTON, January 12, 2022 /PRNewswire/ — Mendix, a Siemens company and global leader in enterprise application development, announced that Utrecht University Medical Center (UMCU), one of the largest public health establishments in the Netherlands, has developed a flexible, workflow-driven digital questionnaire to document side effects of coronavirus vaccinations for special groups and booster vaccinations. The data is transmitted fully automatically to the European Medicines Agency (EMA) for further research. The questionnaire is integrated with the existing “online research platform”, based on the Mendix enterprise low-code platform, which helps researchers with data management services to conduct large international clinical studies. ladder.
In order to measure the side effects of the coronavirus vaccine in special groups, such as pregnant women, through Europe, the EMA asked UMCU, with its famous online research platform, to support the dissemination and collection of research data. National institutions in various European countries study side effects in regular target groups, such as Lareb in the Netherlands.
Secure cloud environment and scalability
The online research platform is used in 45 countries by 6,500 end users – researchers, research nurses and monitors – and processes approximately 400,000 forms per year from more than 350,000 subjects. In addition to developing complex workflows for large-scale, long-term studies, the online research platform is a way for researchers to collect data internationally in a secure cloud environment that complies with laws and regulations. applicable regulations, such as Good Clinical Practice (GCP) .
Given that there will be at least 60,000 participants, and possibly hundreds of thousands more, for this specific study, scalability and capacity were significant challenges. UMCU has chosen to make a copy of the online research platform which allows them to react quickly if the number of participants increases. Additionally, a relatively complex workflow has been set up and new features have been developed to meet the research requirements of the EMA study.
New features developed in record time
A special feature of this workflow is the ability to ‘repeat measurement’, which means that at the time of the next measurement you can ask follow-up questions about previously entered side effect data. For example, if a participant reports signs of a headache during the first measurement, the app will automatically ask them if the headache is still present during the second measurement. The fact that different side effects questions use the same repeated measure question is unique. In addition, a new role has been developed for this research: that of reviewer. Using a common dictionary, the reviewer determines which category the side effect belongs to which is entered by the participant in an open comment box. For example, if a participant reports “chills,” this may be recorded as “flu symptoms.”
Participants register via an online form that creates a user profile in a system called SLIM. SLIM creates an anonymous user in Research Online, but the data in the two systems is strictly separated to prevent confidential information from being combined with research data. For this research, the UMCU developers also developed the possibility for an individual to complete a questionnaire for another participant. For example, a mother can now answer the questions for herself and her child and, in a row, select for which participant the data is entered.
“Without wishing to prejudice other systems or institutions, I believe that the online research platform is the most appropriate platform to conduct this research, both in terms of scalability, flexibility and compliance” , declares Joost Schotsmann, responsible for data management of the Julius Center at UMCU. “Because there was a certain urgency in the request from the EMA, we are very satisfied with the help and involvement we received from the Mendix experts. This collaboration enabled us to act quickly, without making any concessions on the usability and reliability of the search results.”
Joelle de Prez, Customer Success Manager at Mendix, says, “The online research platform is the foundation of many clinical studies, a platform that is constantly evolving and improving. The flexibility of the platform allows deploy new in-depth studies relatively quickly, which is unique in the market.We are delighted that UMCU has chosen Mendix to build this important new module, and that we have had the opportunity to bring our expertise to this project. ”
Mendix, a Siemens company and global leader in enterprise application development, is fundamentally reinventing the way applications are built in the digital enterprise. With the low-code Mendix platform, companies can “do more,” expanding a company’s development capability to overcome the software development bottleneck; “Make it Smart” by building apps with rich native experiences that are intelligent, proactive and contextual; and “Make at Scale” to modernize core systems and build broad application portfolios to keep pace with business growth. The Mendix low-code enterprise platform is designed to promote intense collaboration between business and IT teams and dramatically accelerate application development cycles, while maintaining the highest standards of security, quality, and reliability. governance – in short, to help businesses confidently embark on their digital future. . Mendix’s “Go Make It” platform has been adopted by over 4,000 leading companies worldwide.
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