The goal of WP2 is to define the roadmap and operational framework for the successful accomplishment of SCOPE.

The WP2 specific objectives are:

  • to develop the SCOPE study protocol considering ethics, GCP conformity and documentation;
  • to finalise the documents - also supporting the relevant translations into the local languages of the study sites - and other requirements for the observational study;
  • to inform and train Site Investigators and other associated study personnel regarding study procedures;
  • to fulfil regulatory requirements for conducting the study;
  • to obtain the approval of the SCOPE protocol by Ethical Committees relevant for the study sites.

WP Leader: University of Lodz