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Data and Safety Monitoring Boards (DSMBs) are a common feature of long-term clinical studies in serious and life-threatening conditions. This Workshop describes the remit and composition of DSMBs, and how their work relates to other parties involved in the study, such as the sponsor, the study project team, the investigators, the Steering Committee and the data management centre. The importance of pre-trial preparation by the DSMB is stressed. Consideration is given to the nature and purpose of safety and efficacy data reports presented to the DSMB, and the balance between the timeliness and the accuracy of the data available is discussed. Statistical problems inherent in repeatedly making multiple treatment comparisons are highlighted, and formal stopping guidelines based on repeated safety analyses are presented. The role of the DSMB in trials with pre-specified interim efficacy analyses will be discussed. Date: 10 October 2016 Time: 13:30 - 17:00 Location: Lancaster University Register and further details at: http://www.lancaster.ac.uk/maths/postgraduate/short-courses/list-of-courses/ -- Thomas Jaki, PhD Medical and Pharmaceutical Statistics Research Unit Department of Mathematics and Statistics Lancaster University Lancaster LA1 4YF United Kingdom (+44) 01524 592318 www.mps-research.com http://www.lancaster.ac.uk/maths/about-us/people/thomas-jaki <http://www.maths.lancs.ac.uk/%7Ejaki/> www.ideas-itn.eu You may leave the list at any time by sending the command SIGNOFF allstat to [log in to unmask], leaving the subject line blank.