Adverse event reporting and harms
Death
ADVERSE EVENTS, EVENTS, EVENT
Unexpected problems (UP) are defined according to each institutional IRB of record. The UP will be defined and reported per institutional policy. All serious adverse events will be reported to the local site PI within 24 h of knowledge of the event. Unless stated otherwise in the protocol, all significant adverse events (SAE), expected or unexpected, will be reported to the DSMB as soon as possible, but in all cases within 5 working days of knowledge of the event regardless of the attribution. Death or life-threatening events that are unexpected, possibly, probably, or definitely related to drugs must be reported within 24 h of knowledge of the event. Serious adverse events will be captured from the time of the first protocol-specific intervention, unless the protocol states otherwise, and be reported until 30 days after the last protocol-specific data collection timepoint. Serious adverse events must be followed until clinical recovery is complete and standard of care laboratory tests have returned to baseline, progression of the event has stabilized, or there has been acceptable resolution of the event. Additionally, any serious adverse events that occur after the 30-day time period or protocol-specific timeline that is related to the study treatment must be reported to the relevant IRB.