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Table 1 Schematic overview of the European Register of Cystic Echinococcosis (ERCE) features

From: The first meeting of the European Register of Cystic Echinococcosis (ERCE)

Patients enrolled in ERCE
 − with confirmed or probable CE (direct evidence of infection, imaging-based diagnosis alone or associated with positive serology)
 − in- and out-patients
 − all ages and both sexes
 − first visit or follow-up visit
Data recorded for each patient
 − personal data: year of CE first diagnosis and history of treatments
 − clinical data: cyst(s) localization, size and stage, administered treatment(s)
 − data on the biological samples collected (if any)
 − ERCE complies with Italian (Italian Personal Data Protection Code n. 196, 2003) and European (2000/C 364/01, and Directive 95/46/EC) regulations on the protection and use of personal data
 − two informed consent forms must be signed by patients at initial registration to allow:
  * their data to be recorded in the Register
  * their biological samples to be shipped to the Echino-Biobank
ERCE structure
 − single multicenter database located within the secured IT network of the Italian National Institute of Health (Istituto Superiore di Sanità, ISS) in Rome
 − organized in sheets where patient data are recorded
 − each registered patient is automatically given a unique ERCE ID code
 − data are uncoupled and anonymized
ERCE users
 − physicians working in health centers where patients with CE are managed
 − join ERCE network voluntarily
 − are provided with personal credentials to login to the register
 − different roles are envisaged:
  * the “person in charge” in each centre enters patients’ data
  * the “supervisor” in each centre can read only data of his/her centre
  * the Register “coordinator” has access to and can download data from all national centres
Requirements to join ERCE
 − to be a physician working in centers where CE patients (in- and out-patients) are visited
 − to get the approval from the Ethics Committee (EC) of each centre/country involved (although the implementation of the Register is only observational and does not involve clinical experimentation)
Ownership of data
 − data from individual centres belongs to the individual centres themselves
 − the coordinator can only use cumulative data for periodic presentations on the progress of ERCE
 − publication of data requires the consent of the individual centres