Objectives of the European Porphyria Registry
The EPR aims primarily to conduct an investigation of the natural history, efficacy of treatment regimens and actual clinical practice for people with porphyria across Europe. It also aims to improve quality of care and serve research.
Recruitment of participants
EPR participants are recruited by the European Porphyria Network’s (Epnet) porphyria centres of expertise or by physicians with a special interest in porphyria. Participants were recruited when their diagnosis was established (symptomatic or as part of predictive testing), for treatment and for follow-up.
Data for AIP patients was collected until 2019 during regular and emergency visits to the hospital or primary health care. The registry recorded data such as gender, date of birth, porphyria diagnosis, laboratory test results, symptoms and treatment. Physicians were able to enter consecutive visits for the same participant.
Confidentiality and data protection
Information included in the registry is anonymous (i.e. each record will have a personal pseudonym/code), so that nobody, except the treating clinician can identify the participant. Data stored in the registry is transmitted via a secured encrypted internet system, so that nobody else using the internet can gain access to it.
The registry is located at Haukeland University Hospital, Bergen, and originally has a license from the Norwegian Data Inspectorate in accordance with the EU Data Protection Directive (reference no. 12/00657-3/1UR). From 20.07.2018 the registry is operated in accordance with the new Norwegian Personal Data Act and the EU General Data Protection Regulation (GDPR).
In addition to the data protection, porphyria centres of expertise are required to obtain national and/or local ethical committee approval. All members of Epnet have signed a strict confidentiality agreement concerning access and the publication of data.
Approval by an EPR Steering Committee will be required, as well as local ethical approval for the specific research project when relevant.
The development of the EPR has been funded by NAPOS, Bergen, Norway and the Directorate General for Health & Consumers (DG SANCO), Brussels, Belgium.