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Chapter 9 218 Health Questionnaire 9), and healthcare utilization and productivity loss (Medical Consumption Questionnaire, Productivity Cost Questionnaire). Patients received invitations via email containing a HTML-link to the electronic environment (Castor EDC). If a patient had not completed the questionnaire within two days, two automatic reminders were sent via email. Automated routing, response requirements, and real- time data verification were built in to increase data-quality and completeness. Electronic Case Report File (eCRF) During the study visits and telephone follow-up calls, investigators documented all findings in a cloud-based eCRF (Castor EDC). The eCRF forms were built by the first author with input from the other authors and contained items regarding e.g. demographics, Rome IV diagnostic criteria for IBS, history and physical examination, adverse events, and general wellbeing. Investigators were given unique usernames and passwords to view and add data for their respective inclusion centers. To achieve registration uniformity, the investigators were trained on how to enter data and additional step-by-step instructions were given in standard operating procedure documents. Real time automated data verification and corresponding pop-up notifications were built in to prevent typing errors or other erroneous entries. Automated routing of questions and response requirements ensured that correct items were displayed and filled in. An audit trail enabled tracking of all data changes. Information on the eCRF, the web-based tool used by investigators to monitor study logistics, and privacy and data storage are given in the Supplementary Material. Planning tool – Ldot Ldot is a web-based tool developed by MEMIC and was used to monitor study logistics. All personal patient data were entered into Ldot and the application supported the study workflow by indicating when each study event, e.g. randomization, follow-up call, etc., needed to take place per patient. Ldot was able to communicate with the digital diary and the web-based questionnaires (Castor EDC). For example, all email invitations for the questionnaires were sent automatically via Ldot. Patients’ adherence to the diary and web-based questionnaires could be monitored within Ldot and investigators were notified if patients failed to complete three consecutive days in the diary. Investigators were also notified if patients failed to complete a web-based questionnaire after a reminder was given. To guarantee the anonymity and quality of research data, no research data could be entered into Ldot. Investigators could view and add personal data for their respective inclusion centers. There was no possibility of viewing data from