National Institute on Aging



[pic]

* 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

................
................

In order to avoid copyright disputes, this page is only a partial summary.

Google Online Preview   Download