Suspected unexpected serious adverse reaction SUSAR

If the events are classified as Suspected Unexpected Serious Adverse Reactions (SUSARs) that are fatal or life-threatening, the sponsor must then report them to the Ethics Committee and the Competent Authority within 7 days. Other SUSARs must be reported within 15 days. The sponsor must also inform all other investigators involved in the trial. The Competent Authority is required to enter the information... 

SUSAR suspected unexpected serious adverse reaction (Eudravigilance CT module)... 

In clinical trials of IMPs without a MA, sponsors must report all serious unexpected suspected adverse drug reactions (SUSARs) within eight calendar days if they were fatal or life threatening, and within fifteen days for other serious cases. The initial report has to be followed up within seven days for fatal or life-threatening cases and within fifteen days for other serious reports. These expedited reporting requirements mean that the treatment code in blinded trials must be broken, as it is otherwise impossible to decide which treatment the patient received and, therefore, impossible to determine whether an event could possibly be a reaction if a patient received placebo, then there is no suspicion of a possible adverse reaction to the IMP and authorities do not require expedited... 

SUSAR Serious unexpected suspected adverse drug reaction ... 

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