About the European Porphyria Registry (EPR)
The European Porphyria Registry (EPR) is a multi-centre, international, observational prospective cohort study to include all porphyrias. As a first step, the EPR is developed for patients with acute intermittent porphyria (AIP), but will with time be expanded to include all porphyrias.
- For a more detailed explanation of the EPR and for those with access, please see the ‘EPR Protocol Synopsis’ available from the home page
- For more information about porphyria, including diagnosis and management, or European Porphyria Network (EPNET), visit the EPNET website: http://www.porphyria-europe.org
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. Patients will be informed about the project and will in most countries, depending on local ethical laws, be asked to sign a consent form. Participants are recruited when their diagnosis is established (symptomatic or as part of predictive testing), for treatment and for follow-up. Data will be collected during regular and emergency visits to the hospital or primary health care. The registry will record data such as gender, date of birth, porphyria diagnosis, laboratory test results, symptoms and treatment. Physicians are able to enter consecutive visits for the same participant and have access to their own data.
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, Norway, and has a license from the Norwegian Data Inspectorate in accordance with the EU Data Protection Directive (reference no. 12/00657-3/1UR). 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.
If you are a healthcare professional working with porphyria patients and would like to start using the registry, please contact your local/national porphyria porphyria centres of expertise to find out if they are a member. If they are not, you can contact the EPR Steering Committee to request access: firstname.lastname@example.org
If you are a physician and are interested in becoming an EPR investigator, then please contact us at email@example.com for further information
The development of the EPR has been funded by NAPOS, Bergen, Norway, and the Directorate General for Health & Consumers (DG SANCO), Brussels, Belgium.