National Institute on Aging
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* Investigational Product
-----------------------
Serious Adverse Event/Adverse Event Process Flow
Is event
unexpected
re nature,
severity or
frequency?
Is adverse event
definitely related,
probably related or
possibly related
to
participation in the
research?
Adverse Event
occurs at Study
Site
Submit with
routine
DSMB/Safety
officer reports
PI is notified as soon as
event is known.
Principal Investigator (or designee)
notifies NIA, DSMB Chair or Safety
Officer within 24 hours of being
notified, and also notifies IRB
DSMB Chair, Safety Officer,
or NIA may ask for
additional information
Event is included in
listing of serious adverse
events in DSMB report
Is the serious
event
unexpected,
related or
possibly
related?
Notify other study
investigators for
reporting to their IRBs
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?
Report to IRB,
OHRP, and NIA
generally within 2
weeks of event.
Report to other
participating sites
for their IRB
notification
Is it an IP*?
Report to FDA within 7
days.
Report other serious
and unexpected
events within 15 days
to FDA.
Must be reported
on Adverse
Event form
Is this
adverse
event
serious
?
NO
YES
NO
STOP
Marketed
Drug?
Is the event
fatal,
unexpected, or
life threatening?
YES
NO
YES
YES
YES
NO
NO
YES
NO
YES
NO
YES
STOP
STOP
NO
................
................
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