RITA Registry

RITA Registry – EU4H grant

With the new EU4H grant (2023-2027), ERN RITA will develop and implement an ERN registry in accordance with the grant agreement and corresponding registry Key Performance Indicators (KPIs) as defined by the European Commission. During the grant action the RITA Registry will monitor new patients (diagnosis from 01.01.2024  onwards) with rare immunological diseases treated in RITA HCPs, allowing identification of patients with rare diseases and their respective treating centres within the RITA network.

The KPIs measure the number of new patients uploaded to the ERN registry and the percentage of the total ERN patients uploaded to the ERN registry. Therefore all HCPs in the RITA network are expected to join this registry.

Objective of the RITA Registry

The RITA Registry aims to identify patients (both adults and children) with rare immunological diseases in Europe. For this goal, the RITA Registry will only collect and report Common Data Elements (CDEs) as defined by the European Commission: EU_RD_Platform_CDS_Final.pdf (europa.eu). These CDEs include diagnosis, sex, age, and age at diagnosis. An additional focus of the RITA Registry is cataloguing the treating centres of patients with specific rare diagnoses, thus simplifying engagement with participants for future scientific research.

Target group of the RITA Registry

The RITA Registry is developed for all RITA HCPs and their patients who are diagnosed in January 2024 or later. Researchers and physicians that are planning or conducting research into rare immunological diseases can consult the registry to find how many eligible patients are registered within the network. They can subsequently receive information of the treating hospitals/HCP and contact them via the RITA Registry team for further research collaboration and patient inclusion.

The RITA registry will not replace or compete with existing scientific registries of the partnering scientific societies as it will only contain CDEs and only of patients treated at a RITA HCPs.

Benefits of the RITA Registry

The RITA Registry will make it easier to identify substantial numbers of eligible patients for future research. Future researchers can contact the registry coordinator to discover numbers and location of possible future participants, removing the need to contact over 70 individual hospitals. The Registry will make it clear as to where patients with specific rare diseases are treated and, thus, where specific expertise is likely to be concentrated.

Inclusion & exclusion criteria

Inclusion criteria for patients in the RITA Registry are:

• Treated in a RITA HCP and has provided informed consent.
• Diagnosed with a RITA immunological disease and treated in the European Union and Norway.

Exclusion criteria for patients in the RITA Registry are:

• Diagnosis was made before 01.01.2024.

Data entry

Data entry will be made as easy as possible. Only a very limited number of variables are required for patient entry. HCPs can choose to enter individual patient data manually or bulk upload data for multiple patients at once. The RITA registry coordinating team endorses the setup of electronic data collection (e.g. extraction for electronic medical records) and bulk upload for each HCP. Bulk upload can be performed once every 3-6 months or in any schedule that is convenient. This setup will take some effort once and allow easy and fast data sharing afterwards. An alternative pathway would be to transfer CDEs data of patients already registered in an existing scientific registry of a partner society in order to avoid double data entry. Castor EDC will be the data capture tool to record the CDEs of patients with a RITA diagnosis. This system will also create pseudonyms for every new patient.

Would you like to be one of the first RITA hospitals to contribute to the RITA Registry? Please contact us at rita-registry@umcutrecht.nl. Hospitals that do not contact us will be invited to join the Registry in the upcoming months. More information on the RITA Registry will be available on the RITA website in the near future.

Status update March 2024

The UMC Utrecht, which will host the RITA Registry as RITA coordinating centre, is currently working with the local research board for ethical approval for this project. The implementation of the RITA Registry is scheduled for spring 2024. We will start with a limited number of HCPs and expand gradually.

For questions on the new RITA Registry you can contact us at: rita-registry@umcutrecht.nl

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.