The ERN GUARD-Heart coordination team, in collaboration with the Legal Office of Amsterdam UMC, has developed a template for a Joint Data Registry Agreement (JDRA). This template is an adapted version of the agreement developed by the Dutch Federation of Universities and is intended to facilitate arrangements regarding governance, data sharing, and data access for multicentre patient registries. The template has been specifically designed for use within ERN GUARD-Heart and can be used by centres that wish to establish a registry within the ERN and make use of the coordination and data hosting services provided by Amsterdam UMC. The JDRA consists of several appendices that need to be completed and attached.
The JDRA can be completed by the applying centre for a specific disease or condition and subsequently shared with the centre’s local legal department. The legal department may then provide comments and share the document with Amsterdam UMC for review and further processing.
Importantly, in addition to the JDRA, centres intending to set up a registry are responsible for obtaining local medical ethics approval for the proposed registry and for preparing a patient informed consent form. A template for the informed consent form in all EU languages is available on the website of the ERICA Generated Documents
Download Forms here:
template JDRA_ERN-GUARD-Heart_v0.1 LRS 29Okt2025
JDRA_Projectplan_appendixA_20230718
MASTER_ERN-Registry_Generic-ICF_parents_representatives_en
MASTER_ERN-Registry_Generic-ICF_adult-patients_en
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