'Serious Adverse Event/Adverse Event Process Flow'

Adverse Event occurs at Study Site' is next to 'Must be reported on Adverse Event form' and leads to 'Is this adverse event serious?'.

If 'Is this adverse event serious?' is 'YES', then 'PI is notified as soon as event is known' which leads to 'Principal Investigator (or designee) notifies NIA, DSMB Chair or Safety Officer within 24 hours of being notified, and also notifies IRB', which leads to 'DSMB Chair, Safety Officer, or NIA may ask for additional information', which leads to 'Is it an IP?'.

If 'Is it an Investigational Product?' is 'YES', then 'Is the event fatal, unexpected, or life threatening?'. If 'Is the event fatal, unexpected, or life threatening?' is 'YES', then 'Report to FDA within 7 days.', which leads to 'Is the serious event unexpected, related or possibly related?'.

If 'Is the serious event unexpected, related or possibly related?' is 'YES', then 'Notify other study investigators for reporting to their IRBs', which leads to 'Event is included in listing of serious adverse events in DSMB report', which leads to 'STOP'.

If 'Is the serious event unexpected, related or possibly related?' is 'NO', then 'Event is included in listing of serious adverse events in DSMB report', which leads to 'STOP'.

If 'Is the event fatal, unexpected, or life threatening?' is 'NO', then 'Report other serious and unexpected events within 15 days to FDA', which leads back to 'Is the serious event unexpected, related or possibly related?'.

If 'Is it an Investigational Product?' is 'NO', then 'Marketed Drug?'. 

If 'Marketed Drug?' is 'YES', then it leads back to 'Report other serious and unexpected events within 15 days to FDA'.

If 'Marketed Drug?' is 'NO', then it leads back to 'Is the serious event unexpected, related or possibly related?'.

If 'Is this adverse event serious?' is 'NO', then 'Is event unexpected re nature, severity or frequency?'.

If 'Is event unexpected re nature, severity or frequency?' is 'YES', then 'Is adverse event definitely related, probably related, or possibly related to participation in the research?'.

If 'Is adverse event definitely related, probably related, or possibly related to participation in the research?' is 'YES', then 'Does adverse event suggest that the research places participants or others at a greater risk of physical or psychological harm that was previously known or recognized?'.

If 'Does adverse event suggest that the research places participants or others at a greater risk of physical or psychological harm that was previously known or recognized?' is 'YES', then 'Report to IRB, OHRP, and NIA generally within 2 weeks of event.', which leads to 'Report to other participating sites for their IRB notification', which leads to 'STOP'.

If 'Does adverse event suggest that the research places participants or others at a greater risk of physical or psychological harm that was previously known or recognized?' is 'NO', then 'Submit with routine DSMB/Safety officer reports', which leads to 'STOP'.

If 'Is adverse event definitely related, probably related, or possibly related to participation in the research?' is 'NO', then 'Submit with routine DSMB/Safety officer reports', which leads to 'STOP'.

If 'Is event unexpected re nature, severity or frequency?' is 'NO', then 'Submit with routine DSMB/Safety officer reports', which leads to 'STOP'.