The ERN eUROGEN patient registry

The ERN eUROGEN Patient Registry

The ERN eUROGEN Coordination Team is now actively working to set up the ERN eUROGEN patient registry, which will contain the 16 Joint Research Centre core data elements plus several urogenital-specific data elements.

You can find further information on our registry strategy via the links below:

  1. Aim
  2. Datasets
  3. Stakeholders
  4. Communication strategy
  5. Project management

July 2021 Update:

Before proceeding with the real registry (which will involve 25 years of follow-up), we would like to start with a pilot; the ERN eUROGEN Clinical Practice Snapshots. The aim of this pilot is to get insight into the diagnostic and treatment procedures used, which may differ considerably across healthcare providers (HCPs) and across Europe due to the lack of clear guidelines.

The ERN eUROGEN Clinical Practice Snapshots will cover 5 of the ERN eUROGEN disease areas: 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 tumors. The pilot will only entail very basic information about the diagnosis and treatment procedures performed. The Clinical Practice Snapshots will start with the Common Data Elements (for all patients) followed by 6 disease-specific questions per disease area.

Our initial plan was to perform the pilot anonymously and without asking the patients or their parents for informed consent. However, considering the fact that we are dealing with rare diseases, opinions differ on whether the ERN eUROGEN Clinical Practice Snapshots are anonymous. In addition, opinions differ on whether the data can be collected without asking for informed consent. Therefore, we performed a survey among the HCPs that would contribute to the ERN eUROGEN Clinical Practice Snapshots. The results of this survey were as follows:

  • 10 HCPs did not respond
  • 1 HCP is awaiting the response of their legal department
  • 17 HCPs responded to our survey
    • 6 HCPs need ethical approval, informed consent, and a data transfer agreement to perform the Clinical Practice Snapshots
    • 2 HCPs need informed consent and a data transfer agreement to perform the Clinical Practice Snapshots
    • 4 HCPs need informed consent to perform the Clinical Practice Snapshots
    • 1 HCP needs a data transfer agreement to perform the Clinical Practice Snapshots
    • For 2 HCPs it is unclear what they need to perform the Clinical Practice Snapshots as two persons responded with different answers
    • 2 HCPs are allowed to perform the Clinical Practice Snapshots

With these results, the ERN eUROGEN Registry Advisory Board decided not to make a separate (semi-anonymous) pilot version of the registry, but to just start with the final ERN eUROGEN registry including pseudonymised patients.

We suggest that the HCPs involved start asking for informed consent from the last 50 new patients they treated, then start filling out the Common Data Elements (CDE) and the 6 disease-specific questions. Later, we can add 25 years of follow-up for these patients.

This means that we will need ethical and juridical approval before we can start with the registry. We are currently working hard to get all materials ready for the HCPs to start working on the registry:

  • Practical: We are writing instructions about how to enter patients in Castor and we are finalising the eCRFs in Castor. Once these are ready, we can provide the HCPs involved in the 5 pilot disease areas with login details of a “test version” of the registry, which will allow you to enter imaginary patients and test the registry. We expect this “test version” to be ready in August/September.
  • Legal: We are also working on the legal documents that will be needed to allow the HCPs to enter data in the registry. Once these are ready, we will share them with you, so you can arrange the contracts with your legal department. We expect these documents in September/October.
  • Ethical: We are working on a protocol describing the ERN eUROGEN registry. Besides the documents we are working on, we are waiting for the European informed consent forms that are currently being developed and translated into the different European languages by the European Commission Joint Research Center (EC JRC). Once these forms and the protocol for the ERN eUROGEN registry are ready, we will send you the documents, so you can apply for ethical approval. We expect these documents in October/November. 

In addition, we will start with setting up the data elements to be collected for the 25 years of follow-up and for the Clinical Practice Snapshots for the disease areas that were not included in the pilot. So you may be requested for input there, too.

In conclusion, we are moving forward, and you will be hearing more from us soon.