Use of Terminology Standards to Harmonize COVID-19 Case Report Forms

Clinical studies base their analysis on patient data collected often across cohorts. The COVID-19 pandemic has highlighted the need for collective responses to global health emergencies. This requires swift sharing of information among different research groups based on interoperable data on an international level. We analyzed case report forms used in two multi-country observational COVID-19-related studies and evaluated the selection of semantic standard codes previously used to uniquely identify common clinical study variables (questions and answers) based on the category of information they comprised. Of the 743 variables used commonly in both studies, 79% could be mapped to standard terminologies. There was no terminology that could universally represent all variables; comprehensive mapping of the study variables required the use of concepts from several semantic standards. Furthermore, standard codes for information newly emerging about COVID-19, such as variant details, were not available at the time of mapping.