Implementation

• The eUROGEN registry
• Aim
• Implementation
• Datasets
• Stakeholders
• Projects Granted Access
• Research Results
• Communication Strategy
• Project Management
• GDPR Responsibilities

Implementation

The Principal Investigators at Healthcare Providers (HCPs) involved in ERN eUROGEN as Full Members or Associated National Centres will make sure that implementation of the ERN eUROGEN registry complies with the rules and regulations of their HCP. This may mean that they need to apply for local approval for the implementation of the ERN eUROGEN registry. Participation in the ERN eUROGEN registry is also open to other HCPs.

HCPs will start with retrospective inclusion if they are recognised as a centre of expertise for one or more of the five disease areas for which the Clinical Practice Snapshots were initially developed (1.5 posterior urethral valves, 1.7 anorectal malformations, 1.8 paediatric kidney transplantations, 2.1 complicated & pelvic floor disorders: AMS800 and 3.3 adrenal tumours). These HCPs will start with the prospective inclusion of new patients three months after the start of the retrospective inclusion (which will by then be finalised).

HCPs that are not recognised as a centre of expertise for the five disease areas will start prospective inclusion immediately. For prospective inclusion, all patients treated for a rare uro-recto-genital disease or complex condition for which the HCP is recognised as a centre of expertise will be asked for informed consent using the ERN eUROGEN Informed Consent Forms.

In the retrospective inclusion, all HCPs will make sure that the last 50 new patients per disease area who visited the HCP before 1 January 2022 are identified and asked for their informed consent to have their data entered in the ERN eUROGEN registry. This will be done by sending the specific Patient Information letter for retrospective inclusion and Informed Consent Forms via regular mail to the patient and/or their parents, depending on the age of the patient.

Only patients who provided (or whose parents/legal representatives provided) informed consent will be included in the ERN eUROGEN registry.

In addition, we will start to integrate four existing rare uro-recto-genital disease-specific registries into the ERN eUROGEN registry by assessing their interoperability and the data elements to be imported. We will also prepare the next expansion phase of the registry by defining the data elements for the Clinical Practice Snapshots of the remaining disease areas and by defining the data elements for 25 years of follow-up.