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Workshop key objectives:


 Understanding the terms diagnosis, signs and symptoms; and investigations
 Assessment of causality: the rules within the framework
 Assessment of expectation: when is an event considered expected?
 Downgrading of SUSARs: when is this allowed?
 Query of SAEs
 Interpretation of the RSI
 Managing updates to the RSI
 Coding and the use of MedDRA
 Working through some real examples of SAEs


Note: the workshop is focused on CTIMPs, but several aspects of this are relevant to nonCTIMPs. It will
not cover the rules for Medical Device trials.


To book your place, please email octrutrialshub@ndorms.ox.ac.uk