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