MeRITA main objective is the creation of a metadata registry for sharing essential clinical data provided by all the RITA registries according to the EU standards.

Our main aim is to support the merging of key information (so called common data elements see Documents )from all registries to ensure their interoperability with other European rare disease registries for cross fertilisation of ideas and further development of clinical research.

Moreover, one of the objective of MeRITA project is to identify potential additional items which could be common for all diseases within the boundaries of the diseases taken care by RITA.

Your registry will remain independent and continue to run on its own, your registry data will remain property of your registry: the participation to MeRITA will give to participating registries a greater international visibility, making them findable through a structured search function.

Stakeholders, once logged in with a verified account, will get in contact with each registry’s owner participating in MeRITA in order to request the export of the data, this will help to assess the feasibility of clinical trials, to facilitate the planning of appropriate clinical trials and to support the enrolment of patients.

Medium and long-term sustainability

Currently operational, the MERITA registry only needs minimal financial resources for technical operation of the registry. MeRITA receives data from existing ERN RITA affiliated registries. These ERN RITA affiliated registries are established registries with their own funding. Therefore, MERITA can operate with a minimum of costs, which makes it sustainable. The centralised registry approach will be maintained, but needs adjustments in the future in order to align with the criteria of the new EU4H grant, the Joint Action starting in 2024 (JARDIN project) and the European Health Data Space (in the long term ERN RITA wants develop a federated registry system).

Transition phase of MeRITA from Istituto Giannina Gaslini to UMC Utrecht, ERN Coordinating Centre

In the new ERN EU4H grant, UMC Utrecht will be responsible for developing and implementing a registry that will enable network HCPs to enter new patient data on an annual basis. The planned registry will collect prospective data compared to the retrospective data collected by MeRITA. The MeRITA data will be migrated to a dedicated and secure server at UMC Utrecht in the beginning of 2024. The exact date will be depend on the collaboration agreements between UMC Utrecht and existing registries for the new registry collecting prospective network HCP data. These agreements also guarantee that when new network HCP patients are identified but not yet enrolled in existing registries (such as Pharmachild, ESID): HCPs will be referred to these existing registries for patient enrolment. This mutual benefit will enhance collaboration with scientific societies, which is key to the sustainability of the registry.

In line with the criteria of the new ERN EU4H call, ERN RITA will develop an additional registry system that also enables direct patient data entry by network HCPs. HCPs will be able to enter Common Data Element data of new patients on an annual basis. Sustainability will be ensured by a new web-based registry system that is accessible and free of charge to use by all network HCPs. In addition, it also facilitates easier transfer in case an ERN RITA HCP takes over the coordination of the network. Sustainability, efficient use of expertise and resources will be ensured through:

1. The establishment of a Registry Governance involving all stakeholders and making use of the expertise built up by the MeRITA project core team. The Registry Governance will consist of Executive- , Steering- , Legal/Ethical- Committee, Implementation Team (+ training/FAIR), RITA Registry Local Investigator (at every HCP).
2. the continuous close collaboration with:

-Existing registries and scientific societies

-EC Joint Research Centre Registry Team, with the main focus on the use of ERDRI and SPIDER

-European Rare Disease Research Coordination and Support Action consortium ERICA

-The new 10 year ERDREA project (starting fall 2024) as a follow-up on the EJP-RD European Joint Programme on Rare Diseases project, incorporating also the ERICA project outcomes.

-The Orphanet Data for Rare Disease project (OD4RD): ERN RITA actively takes part in meetings and activities to improve (the use of) Orphanet nomenclature and orphacodes to be used by HCPs for patient number monitoring, registries, CPMS (also future integration of SPIDER in CPMS).

-ERN registry teams of other ERNs using the same approach

ERN RITA will maintain its centralised registry approach during the new ERN EU4H grant, but will also explore the options for the long-term development of a federated approach, using both the retrospective data of existing registries (scientific societies, national, regional, local) and the prospective data of network HCPs. For this, ERN RITA collaborates closely with the above-mentioned partners and will use its results and structures. ERN RITA is also a stakeholder in the JARDIN Joint Action. The overall objective of JARDIN is sustainability of ERNs as networks as well as their specific activities such as registries.

ERN RITA also makes use of the results of registry related activities aimed at a federated infrastructure, such as the EHDS Pilot 2 (the pilot implementation phase of the European Health Data Space - EHDS).