Is RITA Registry safe?
Safeguarding patient data in the RITA Registry is of great importance to RITA. Data is collected in Castor EDC, a platform with ISO 27001 certification. Access to patient data is restricted to the treating centre and the registry team, guaranteeing confidentiality. Patient data is pseudonymized, accessible only to authorized personnel in the patients treating centre via unique codes.
How does data entry work?
Data entry will be within Castor EDC. The data entry can be done either manually per patient, or as a bulk upload where you upload data for multiple patients at once. For this latter option, a spreadsheet file can be uploaded into the Castor environment, which could be done, for example, once or twice a year.
Which coding system is the RITA Registry using for diagnoses?
For Autoimmune (AI), Autoinflammatory (AID) and Paediatric Rheumatological (PR) patients, the Orpha code system is used in the RITA Registry. In case of manual data entry, the diagnoses names are used and linked to Orpha codes on the back-end. For PID patients, an HGVS code or OMIM code can be entered for genetic diagnoses. If no genetic code is known, we ask you to provide an Orpha code for this patient.
How does reimbursement work?
Healthcare Providers can request reimbursement for their participation in the RITA Registry after obtaining ethical approval in their own hospital and setting up a system for data entry. Reimbursement will be based on the data upload (bulk or manually). For more details, please refer to the RITA Registry Reimbursement protocol.
Can non-RITA HCPs join?
Currently, the RITA Registry primarily targets ERN RITA HCPs. Given that 71 HCPs are ERN RITA members, our focus initially lies in assisting these hospitals with RITA Registry implementation, mainly due to the fact that there will be European Commission Key Performance Indicators for the HCPs participating in the RITA Registry.