European Cystic Fibrosis Society

Obtaining the necessary patient consents is an essential part of joining the ECFS Patient Registry, as required by the EU Directive 95/46/EC. As each participating country will have its own legal interpretation of this Directive, it is important to check the suggested sample consent forms with your local Data Protection Officers.

Furthermore, patients should be notified accurately of all plans for collecting and processing their data, and this is determined by the design of the ECFS Patient Registry. The explanatory information sheet provides fuller information. The various documents needed for application to your local data protection authorities can be downloaded from this page.   If you have any questions, please contact Hanne Vebert Olesen (), before you get started.

Please follow the relevant course below depending on whether your country already has patient consents or not.

If you have existing consents which satisfy your local laws:

• If you already have existing consents, please check with your local Data Protection Officer to make sure these forms meet the requirements of the new European Registry or whether you will need new patient consents. e.g. using the
  "Patient Information Sheet" Template and
  "Patient Consent Form" Template.
• If your local Data Protection Officer approves your existing consents, please inform Hanne Vebert Olesen () along with a copy of the approval from your data protection authorities.  This approval should be in English.  if not we will need both the original document and a translation.  Furthermore, we will need a signed statement from either your country representative if you have a national registry, or from the single center representative (download the statement here).

If you do not have existing consents, or you need new patient consents:

• Make an application to your local/national data protection authorities for storing data on your local computer as well as exporting anonymous data to the ECFS.  The following documents downloadable from this page will be needed for the application:
  ECFR Registration 
  ECFR Registration Terms 
  ECFR Software Security.
• The Patient Information Sheet Template and Patient Consent Form Template must be changed to meet any requirements of your local legal and ethics laws, and translated to your own language.
• When your application has been approved by your local data protection agency, please inform Hanne Vebert Olesen () along with a copy of the approval from your data protection authorities. This approval should be in English.  If not we will need both the original document and a translation.  Furthermore, we will need a signed statement from either your country representative if you have a national registry, or from the single center representative (download the statement here).
• Patients can only be entered into the registry once you have received their signed, informed consent to do so.  Please store all the consent forms that your patients have signed safely in your local hospital.

It is the responsibility of the reporting centres/countries/registries to have the acquired permissions to export/report data to the European registry.  It is the responsibility of the ECFS and the European registry steering committee to check these permissions before any data are received.  It is the responsibility of the ECFS and the ECFS Patient Registry Steering Committee that the data are stored and handled according to Danish, Italian and EU Data Protection laws.  The ECFS Patient Registry is registered under the Danish Data Protection Agency, file no 2007-41-0909.

For questions concerning the above please feel free to contact Hanne Vebert Olesen ()