Study subject approvals package

TASK 33 Execution of the study M8M17 UMCU Ava Julius Clinical The partners of the consortium have extensive experience in the setup site selection recruitment and the monitoring of large multicountry studies for both academic and pharma industry purposes with study results used in the context of regulatory decisionmaking JCR will manage and monitor the study and its progress making sure timelines are being met and performing quality and data monitoring to assure the delivery of data of a quality fit for purpose A higher level of support is expected to be required than in traditional studies to address concerns specifically related to the remote monitoring approach