RABBIT-SpA-register description

Patients and physicians complete pseudonymized electronic case report forms (eCRF) in a web-based documentation system, which was specifically designed for RABBIT-SpA, without the need to install specific desktop software. Physicians and patients complete questionnaires after 3 and 6 months and thereafter twice a year for 5 years with the possibility of extension to up to 10 years. Sociodemographic parameters, laboratory values, clinical parameters, treatment details, and physician and patient endpoints as well as safety events are collected. The DRFZ receives physician and patient questionnaires electronically. Configurable roles with individual rights are assigned to each participant (physician, study nurse, patient, technical administration, and trustee and research group). This ensures that only the content and data assigned to the role can be accessed at any time, thus complying with the applicable German and European data protection regulations. To allow the study centers and patients a convenient entry into the system, several instructional videos, for example on how to add patients and how to access the eCRFs, were created and posted on the study homepage. As the documentation is often carried out during consultation hours with limited time, the eCRFs and the documentation system have to be as intuitive and user friendly as possible. To achieve this, several functions have been implemented. The system reminds the participants of pending questionnaires. If a questionnaire has not been completed in a predefined period, it automatically expires and will be submitted automatically. In case the required data such as laboratory values are not yet completely available, the eCRF can still be submitted. Therefore, the eCRF can be submitted despite implausible or missing values. Only the date of the survey and the information on medication are mandatory fields, without which the eCRF cannot be submitted manually. Although plausibility checks have also been implemented on patient eCRFs, the monitoring process refers exclusively to eCRFs filled in by physicians.