JMIR Publications

ABSTRACT

Case report forms (CRFs) are the instrument used by research organizations worldwide to collect information about patients and study participants with the purpose to answer specific questions, assess efficacy and safety of medical products and in general to improve prevention and treatment in healthcare. To obtain significant research results out of the collected data, CRFs should be designed following the recommendations issued by regulatory authorities. However, we believe that semantic interoperability in CRFs has not yet been properly addressed. Within an international consortium comprising several COVID-19 cohorts, we scrutinized the questions included in the different CRFs with the purpose to establish semantic interoperability across the different study data elements. Based on the experience acquired, in this article, we provide five guiding principles on how to design CRFs to support semantic interoperability and increase data quality while also facilitating the sharing of data. We conclude by urging authorities to establish an international coordination board for standards and interoperable clinical study data with competence in clinical data, interoperability standards and data protection as part of a preparedness plan for future pandemics or other health threats.