Quality Assurance and networking is dedicated to ensure high-quality trial outcomes by implementing quality assurance systems in all trial sites and closely monitoring study activities and safety data and the sustained development of CHMI capacities and CHMI platform that ensures vaccine development activities beyond the project. Trial specific DSMBs are established to provide oversight for CHMI trials and field efficacy trials.
The sponsors with delegation to EVI and the CROs (selected by EVI) ensures that the studies and trials are performed and data are generated, documented and reported in compliance with ICH GCP and applicable regulatory requirements, and are standardised across the sites.
This work package is led by the European Vaccine Initiative EWIV (EVI) in collaboration with the clinical trial sites. Its specific objectives are, to: