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New App Tracks Side Effects of COVID-19 Vaccinations

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A powerful ‘Research Online Platform’ application was built with the Mendix enterprise low-code solution by University Medical Center Utrecht and is now used in 45 countries by 6,500 end users. Data from at least 60,000 participants will be sourced and analyzed for study by the European Medicines Agency (EMA). Flexibility and scalability are key features of successful Research Online Platform built on Mendix’ low-code platform. New features, such as repeat measure, quickly added to meet needs of EMA.

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Mendix, a Siemens business and the global leader in enterprise application development, announced that University Medical Center Utrecht (UMCU), one of the largest public health care institutions in the Netherlands, developed a flexible workflow driven digital questionnaire to document the side effects of coronavirus vaccinations for special groups and booster vaccinations. Data is delivered fully automatically to the European Medicines Agency (EMA) for further research. The questionnaire is built in the existing ‘Research Online Platform,’ based on the Mendix enterprise low-code platform, that helps researchers with data management services in conducting large-scale international clinical studies.

In order to measure the side effects of the coronavirus vaccine in special groups, such as pregnant women, across Europe, the EMA has asked the UMCU, with its acclaimed Research Online Platform, to support the distribution and collection of research data. National institutions in various European countries investigate the side effects in regular target groups, such as Lareb in the Netherlands.

Secure cloud environment and scalability

The Research Online Platform is used in 45 countries by 6,500 end users — researchers, research nurses, and monitors — and processes about 400,000 forms per year from over 350,000 subjects. In addition to developing complex workflows for large-scale and long-term studies, the Research Online Platform is a way for researchers to collect data internationally in a secure cloud environment that complies with applicable laws and regulations, such as Good Clinical Practice (GCP).

Because there will be at least 60,000 participants, and perhaps hundreds of thousands more, for this specific study, both scalability and capacity were important challenges. UMCU chose to make a copy of the Research Online Platform that allows them to respond quickly if the number of participants increases. In addition, a relative complex workflow has been configured and new features developed to meet the research requirements for the EMA study.

New features developed in record time

A special feature of this workflow is the possibility of ‘repeat measure,’ which means that, at the next measurement moment, you can ask follow-up questions on side effect data that was previously entered. For example, if a participant reports signs of a headache at the first measurement, he or she will be automatically asked by the application whether the headache is still present at the second measurement. The fact that different side effect questions make use of the same repeat measure question is unique. Also, a new role has been developed for this research: the reviewer. Using a common dictionary, the reviewer determines to which category the side effect belongs that is entered by the participant in an open comment box. For example, if a participant reports ‘chills’ this can be recorded as ‘flu symptoms.’

Participants register themselves via an online form which creates a user profile in a system called SLIM. SLIM creates an anonymous user in Research Online, but the data of the two systems is strictly separated in order to protect privacy information from being combined with research data. For this research, the developers at the UMCU also developed the capability for an individual to fill in a questionnaire for another participant. For example, a mother can now answer the questions for herself and her child and, in a sequel, select for which participant the data is entered.

“Without wanting to shortchange other systems or institutions, I think the Research Online Platform is the most suitable platform to conduct this research, both in terms of scalability, flexibility, and compliance,” says Joost Schotsman, head of Julius Center data management at UMCU. “Because there was some urgency in the EMA’s request, we are very pleased with the help and involvement we received from the experts at Mendix. This collaboration enabled us to act quickly, without making concessions on the usability and the reliability of the research results.”

Joelle de Prez, customer success manager at Mendix, says, “The Research Online Platform is the foundation for many clinical studies, a platform that is constantly evolving and getting better. The flexibility of the platform makes it possible to roll out extensive new studies relatively quickly, which is unique in the market. We are delighted that UMCU chose Mendix to build this important new module, and that we had the opportunity to contribute our expert knowledge to this project.”

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Editor in chief is Linda Hohnholz.

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