The goal of WP3 is the coordination of the operational management of the study, the successfully accomplishment of patients’ recruitment and follow-up, the cumulative review of study data to evaluate safety, study conduct, and scientific validity and data integrity of the study.

The WP3 specific objectives are:

• to perform the activities related to study initiation/monitoring/closure;
• to provide data management and quality control of data and filing;
• to manage safety data and procedures;
• to perform patient screening and enrolment in the study;
• to follow up patients according to protocol procedures;
• to register and follow up major clinical events

WP Leader: Erasmus University Medical Center