How to join the Registry

Essential for participation in the Registry is the informed consent from patients, as required by the EU General Data Protection Regulation (GDPR) 2016/679. Patients must clearly be informed how their data will be collected, stored, processed, and used and sign an ICF. Full details are outlined in the Patient Information Sheet and Consent Form.

Please be aware that your country may have additional legal requirements. We recommend discussing the sample ICF provided by the Registry with your local Data Protection Officer to ensure compliance with national regulations and use it as a guide.

Depending on whether your country has existing patient consent forms or not, choose A or B

A) If you already have a consent form that meets your national requirements:

• Verify with your local DPO if the existing ICF at your centre aligns with the Registry standards. You can use the Registry (ECFSPR) ICF template as a reference.
• Send a copy of the approved ICF to coordination@ecfregistry.eu.

B) If you need to create or update your ICF:

• Use the Registry (ECFSPR) ICF template as a basis, adapt it to comply with local legal and ethical standards, and translate it into your national language.
• Send a copy of the approved ICF to coordination@ecfregistry.eu.

You must obtain approval from your national data protection authority confirming that:

• centres in your country are authorised to collect data and transfer pseudonymised data to the Registry;
• this data will be stored on the Registry’s secure webserver located at Hetzner Online GmbH in Germany.

In cases where national approval is not possible, individual centres will need to apply directly to their local hospital ethics committees.

Once approval has been granted, please send a copy of the official documents to coordination@ecfregistry.eu. If the documentation is not in English, you will also need to provide an English translation alongside the original.

A signed statement is required from your official representative—either from the national registry lead (Statement NR ) or the centre lead (Statement Centre) – that your centre meets the Legal and ethical requirements. The document should also include the name of the person who will represent your country in the ECFSPR Steering Group.

To support your submission to your local data protection authorities, all the necessary documents are available for download on this page (see below).

If you need guidance or have any questions, feel free to contact us at coordination@ecfregistry.eu.

It is the responsibility of the reporting centres, national registries, or countries to ensure they have obtained the necessary permissions to export or report data to the ECFSPR. The ECFS and the Registry’s Steering Committee are responsible for verifying that these permissions are in compliance with applicable regulations before any data is received. They are also responsible for ensuring that all data is stored and managed in accordance with current EU data protection legislation.

The Registry was formerly registered under the Danish Data Protection Agency, file no. 2013-41-2105. Since the new EU General Data Protection Regulation (GDPR) 2016/679, which came into effect on 25 May 2018, formal registration or approval for private registries is no longer required. Instead, organisations must implement internal procedures that comply with the Regulation and are subject to review by the relevant Data Protection Authorities.