Patient Registry
   
A crucial objective of EuroPa is the establishment of a central registry of clinically well described patients, combined with a web-based entry system. This registry will give EuroPa an advantage in planning and conducting multi-centre clinical trials and research projects. Recruiting patients that both fulfil diagnostic criteria and who are interested in participating in trials can be time consuming. A regularly updated central data base will be beneficial in accelerating the patient recruitment process. In the long term, research results will be gained in a shorter period of time and new therapies will be available earlier.

Participation in the EuroPa registry is voluntary and each patient signs a consent form prior to data entry. At present, only patients at the participating clinical centres will be included into the registry. A uniform questionnaire – the minimal data set – will be used to gather comparable clinical data from all patients. Clinical data of all patients are stored pseudonymised. Only the responsible staff at the treating clinical centre is able to re-identify a certain patient. Re-identification will be necessary for follow-up visits in order to update the clinical data and to inform patients about any planned study or trial.

Technical implementation

Access to the patient registry is password-protected and reserved to authorised staff only. Each participating clinical centre can only access its own data. Clinical data is be stored anonymised, that is, patient personal data (name, date of birth, address) is not stored in the central database. As it is illustrated in the figure below, a pseudonym (Patient Identification Code - PID) will be allocated randomly to each patient in order to reference the medical data in the central database. A document mapping the PID and the respective personal data has to be printed and stored safely by the responsible physician in compliance with local data protection regulations.
   
IT infrastructrue of the EuroPa patient registriy
Schematic view on IT infrastructure of the EuroPa patient registry
 
Besides a regular web browser, no additional software is required at the site of the user. EuroPa participants who are authorised will access the external web server in order to send information to the central database. Information is exchanged by means of a web application, providing the questionnaire and various options for data entry. The external web server is then requesting the required information from the database and passing information back to the EuroPa participant. Data transfer will be encrypted. The database on the central server is only communicating with the internal web server. The patient registry is further protected against misuse by various security measures.

The EuroPa IT-infrastructure is being developed by the interActive Systems GmbH, Berlin (Germany).
 

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