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29 December 2010


Laurent BASSET

Dear Dr Stark,

According to your sentence just below, could you precise me if all the AE (not serious ones) will have to be sent to Ethics Committee during a study on MD?


The first difference is the heavy level of adverse event reporting in Europe. Even for European Class I and IIa devices, all adverse events are reportable to sponsors, Ethics Committees

Nancy J Stark

Yes, ALL adverse events, including stubbed toes, bar fights, and cat bites must be reported. The test is if the subject told the investigator. If the subject mentions any unwanted medical occurrence it must be reported--poor ECs, they won't know what's hit them!

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