Datasets

The ERN eUROGEN platform will be built on the collection of core data set elements and domain specific elements and will be combined with data from existing registries for specific rare urogenital diseases, and thus the registry will comprise the following sets of data:

  1. The JRC common data set (CDS) defined by the EU RD Platform with 16 data elements describing the general health status of the patients. The CDS is common to all rare disease registries and the connecting point for all ERN databases and ensures that each individual is uniquely identified and not duplicated in different RD registries.
  2. Urogenital pilot data set initially consisting of six clinical questions (around 10 data elements) about the last 30 cases/workstream for each HCP, in order to perform a clinical snapshot of the current practices in EU. After finalization of the present project, the dataset will be expanded with additional data points (key performance and outcome indicators) defined by the experts of the three ERN eUROGEN workstreams, relevant for all 114 rare urogenital diseases and complex conditions.
  3. Disease-specific modules will incorporate (in the future) the information already contained in AGORA, Saturn, Venus, ARM-Net in a modular system to allow expansion with future registries or trials.

The data in the eUROGEN Registry will be made Findable, Accessible, Interoperable, and Reusable for humans and computers (i.e., FAIR). To achieve this, eUROGEN will work with Bruna Dos Santos Vieira, “FAIRification” steward of the European Joint Program on Rare Diseases (EJP-RD).

During the project period the HCP centres will add their cases while existing disease-specific registries will undergo a process of fairification to be integrated into ERN eUROGEN using the common data elements. In the future, other national registries will be considered, and a patient portal will be created for surveys on quality of life, among others