Balancing on-site and central monitoring: Where does new evidence leads us? SCT/ICTMC 2017 – Invited Session

Setting On-site monitoring is… time-consuming resource hungry Many interpret GCP to require much site monitoring Academic trials = fewer site visits, industry trials = more Many suggest to focus more on central monitoring Many suggest that only site visits can find key problems Limited evidence to judge central vs on-site balance Some teams have run studies: ADAMON, OPTIMON, TEMPER

Session plan Will Cragg + Sally Stenning TEMPER – first results 18 min MRC Clinical Trials Unit at UCL, London, UK Valerie Journot OPTIMON 18 min INSERM, Paris, France Dirk Hasenclever ADAMON – first results 18 min IMISE, University of Leipzig, Germany Anne Lindblad Discussion 15 min Emmes Corporation, USA Panel discussion With audience questions To end