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