Table 3 SAE reporting

cIRB (SMART IRB definition)

Yearly (minimum)/at continuing review

For continuing review;

Submitted to IRB via DCOC

Local IRB

Per local IRB policies and procedures

DCOC (Sponsor, per SMART IRB definitions, and lead trial team)

Immediately, but no later than 48 h after finding out about the event

CO-SOP-012.v1.0/SOP

Overall PIs (per SMART IRB definitions)

Immediately, but no later than 24 h after finding out about the event

Medical Monitor

Per DSMB charter

DSMB

Per DSMB charter