ACRP CRC Exam Questions With Correct
Answers
An /adverse /event /is /defined /as /one /which:
a) /Results /in /hospitalization
b) /Causes /a /disability
c) /Is /not /necessarily /causally /related /to /the /drug
d) /Is /life /threatening /- /verified /answer(s)-✔✔C) /Is /not /necessarily /causally /related /to /drug
An /adverse /event /is /one /which:
a) /Is /an /unfavorable /and /unintended /sign, /symptom, /or /disease
b) /Is /one /that /is /temporally /associated /with /drug /regardless /of /whether /it /is /related /or /not
c) /A /Only
d) /A /and /B /- /verified /answer(s)-✔✔d) /A /and /B
A /subject /in /an /arthritis /clinical /trial /develops /a /severe /cold /and /flu /like /symptoms. /This /event
/is /most /likely /classified /as:
a) /an /adverse /event
b) /an /adverse /drug /reaction
c) /an /unexpected /adverse /drug /reaction
d) /a /serious /adverse /event /- /verified /answer(s)-✔✔A) /An /adverse /event
A /response /to /a /medical /product /means /(Select /all /that /Apply):
a) /A /causal /relationship /between /drug /and /adverse /event /is /established
,b) /A /causal /relationship /between /drug /and /adverse /event /is /a /reasonable /possibility
c) /The /relationship /of /the /event /to /drug /cannot /be /ruled /out
d) /An /event /that /requires /active /medical /intervention /- /verified /answer(s)-✔✔b /and /c. /B) /A
/causal /relationship /between /drug /and /adverse /event /is /a /reasonable /possibility /and /C) /The
/relationship /of /the /event /to /drug /cannot /be /ruled /out.
An /adverse /drug /reaction /is /one /which:
a) /Results /in /death /or /hospitalization
b) /A /noxious /and /unintended /response /to /a /drug
c) /Occurs /frequently /and /with /greater /severity /than /usual.
d) /Likely /occurs /at /normal /doses /of /the /drug /- /verified /answer(s)-✔✔B) /A /noxious /and
/unintended /response /to /a /drug
For /a /drug /that /is /in /a /Phase /IV /trial /an /adverse /drug /reaction /is /one /which:
a) /Is /noxious /and /unintended
b) /Occurs /at /normal /doses /used /for /prophylaxis
c) /A /only
d) /A /and /B /- /verified /answer(s)-✔✔d) /A /and /B
A /serious /adverse /event /is /one /which /results /in:
a) /Death /or /life-threatening /event
b) /A /hospitalization /or /prolongation /of /hospitalization
c) /Persistent /or /significant /disability
d) /All /of /the /Above /- /verified /answer(s)-✔✔d) /All /of /the /above
The /term, /life-threatening, /in /a /serious /adverse /event /refers /to:
a) /An /event /which /required /hospitalization
,b) /An /event /where /risk /of /death /was /evident /at /the /time /of /the /event
c) /An /event /that /required /treatment /in /an /emergency /room
d) /An /event /which /might /have /caused /a /death /if /left /untreated /- /verified /answer(s)-✔✔b) /An
/event /where /risk /of /death /was /evident /at /the /time /of /the /event.
An /event /may /be /classified /as /serious /if /it:
a) /Not /immediately /life /threatening, /but /may /jeopardize /the /patient
b) /Not /immediately /life /threatening, /but /may /require /an /intervention /to /prevent
/hospitalization
c) /A /only
d) /A /and /B /- /verified /answer(s)-✔✔d) /A /and /B
A /patient /in /a /clinical /trial /for /joint /pain /experiences /a /bronchospasm /while /at /home. /The
/event /would /be:
a) /not /reportable /because /it /occurred /in /a /home /setting
b) /An /adverse /event /which /does /not /require /reporting
c) /An /unexpected /adverse /event /which /does /not /require /expedited /reporting
d) /May /be /considered /serious /and /should /be /considered /for /expedited /reporting /- /verified
/answer(s)-✔✔d) /May /be /considered /serious /and /should /be /considered /for /expedited
/reporting
Events /which /may /be /classified /as /serious /even /though /they /do /not /result /in /hospitalization
/include:
a) /Allergic /bronchospasm
b) /Blood /dyscrasias
c) /Convulsions
d) /All /of /the /above /- /verified /answer(s)-✔✔d) /All /of /the /above
, An /unexpected /adverse /reaction /is /one /which /is:
a) /Not /expected /by /the /investigator
b) /Not /mentioned /in /the /Investigator's /brochure /or /relevant /source /document
c) /Classified /as /such /by /the /IRB
d) /Classified /as /such /by /the /sponsor's /medical /safety /officer. /- /verified /answer(s)-✔✔b) /Not
/mentioned /in /the /Investigator's /brochure /or /relevant /source /document.
Which /of /the /following /is /an /unexpected /adverse /event?
a) /A /report /which /adds /significant /information /to /an /already /documented /serious /adverse
/event.
b) /A /report /of /interstitial /nephritis /in /a /patient /with /acute /renal /failure
c) /A /report /of /fulminant /hepatitis /in /patient /with /an /initial /report /of /hepatitis.
d) /All /of /the /above /- /verified /answer(s)-✔✔d) /All /of /the /above
For /expedited /reporting /an /event /must /be:
a) /Serious
b) /Serious /and /Unexpected /
c) /Only /temporally /associated /with /drug /administration
d) /Causally /related /to /drug /administration. /- /verified /answer(s)-✔✔b) /Serious /and
/Unexpected
According /to /ICH /serious /unexpected /reaction /to /a /drug /should /be:
a) /Submitted /to /the /appropriate /regulatory /authority /within /one /week.
b) /Submitted /to /the /appropriate /regulatory /authority /within /15 /days.
c) /Submitted /to /the /appropriate /regulatory /authority /on /an /expedited /basis.
d) /Submitted /promptly /to /the /IRB /- /verified /answer(s)-✔✔c) /Submitted /to /the /appropriate
/regulatory /authority /on /an /expedited /basis.
Answers
An /adverse /event /is /defined /as /one /which:
a) /Results /in /hospitalization
b) /Causes /a /disability
c) /Is /not /necessarily /causally /related /to /the /drug
d) /Is /life /threatening /- /verified /answer(s)-✔✔C) /Is /not /necessarily /causally /related /to /drug
An /adverse /event /is /one /which:
a) /Is /an /unfavorable /and /unintended /sign, /symptom, /or /disease
b) /Is /one /that /is /temporally /associated /with /drug /regardless /of /whether /it /is /related /or /not
c) /A /Only
d) /A /and /B /- /verified /answer(s)-✔✔d) /A /and /B
A /subject /in /an /arthritis /clinical /trial /develops /a /severe /cold /and /flu /like /symptoms. /This /event
/is /most /likely /classified /as:
a) /an /adverse /event
b) /an /adverse /drug /reaction
c) /an /unexpected /adverse /drug /reaction
d) /a /serious /adverse /event /- /verified /answer(s)-✔✔A) /An /adverse /event
A /response /to /a /medical /product /means /(Select /all /that /Apply):
a) /A /causal /relationship /between /drug /and /adverse /event /is /established
,b) /A /causal /relationship /between /drug /and /adverse /event /is /a /reasonable /possibility
c) /The /relationship /of /the /event /to /drug /cannot /be /ruled /out
d) /An /event /that /requires /active /medical /intervention /- /verified /answer(s)-✔✔b /and /c. /B) /A
/causal /relationship /between /drug /and /adverse /event /is /a /reasonable /possibility /and /C) /The
/relationship /of /the /event /to /drug /cannot /be /ruled /out.
An /adverse /drug /reaction /is /one /which:
a) /Results /in /death /or /hospitalization
b) /A /noxious /and /unintended /response /to /a /drug
c) /Occurs /frequently /and /with /greater /severity /than /usual.
d) /Likely /occurs /at /normal /doses /of /the /drug /- /verified /answer(s)-✔✔B) /A /noxious /and
/unintended /response /to /a /drug
For /a /drug /that /is /in /a /Phase /IV /trial /an /adverse /drug /reaction /is /one /which:
a) /Is /noxious /and /unintended
b) /Occurs /at /normal /doses /used /for /prophylaxis
c) /A /only
d) /A /and /B /- /verified /answer(s)-✔✔d) /A /and /B
A /serious /adverse /event /is /one /which /results /in:
a) /Death /or /life-threatening /event
b) /A /hospitalization /or /prolongation /of /hospitalization
c) /Persistent /or /significant /disability
d) /All /of /the /Above /- /verified /answer(s)-✔✔d) /All /of /the /above
The /term, /life-threatening, /in /a /serious /adverse /event /refers /to:
a) /An /event /which /required /hospitalization
,b) /An /event /where /risk /of /death /was /evident /at /the /time /of /the /event
c) /An /event /that /required /treatment /in /an /emergency /room
d) /An /event /which /might /have /caused /a /death /if /left /untreated /- /verified /answer(s)-✔✔b) /An
/event /where /risk /of /death /was /evident /at /the /time /of /the /event.
An /event /may /be /classified /as /serious /if /it:
a) /Not /immediately /life /threatening, /but /may /jeopardize /the /patient
b) /Not /immediately /life /threatening, /but /may /require /an /intervention /to /prevent
/hospitalization
c) /A /only
d) /A /and /B /- /verified /answer(s)-✔✔d) /A /and /B
A /patient /in /a /clinical /trial /for /joint /pain /experiences /a /bronchospasm /while /at /home. /The
/event /would /be:
a) /not /reportable /because /it /occurred /in /a /home /setting
b) /An /adverse /event /which /does /not /require /reporting
c) /An /unexpected /adverse /event /which /does /not /require /expedited /reporting
d) /May /be /considered /serious /and /should /be /considered /for /expedited /reporting /- /verified
/answer(s)-✔✔d) /May /be /considered /serious /and /should /be /considered /for /expedited
/reporting
Events /which /may /be /classified /as /serious /even /though /they /do /not /result /in /hospitalization
/include:
a) /Allergic /bronchospasm
b) /Blood /dyscrasias
c) /Convulsions
d) /All /of /the /above /- /verified /answer(s)-✔✔d) /All /of /the /above
, An /unexpected /adverse /reaction /is /one /which /is:
a) /Not /expected /by /the /investigator
b) /Not /mentioned /in /the /Investigator's /brochure /or /relevant /source /document
c) /Classified /as /such /by /the /IRB
d) /Classified /as /such /by /the /sponsor's /medical /safety /officer. /- /verified /answer(s)-✔✔b) /Not
/mentioned /in /the /Investigator's /brochure /or /relevant /source /document.
Which /of /the /following /is /an /unexpected /adverse /event?
a) /A /report /which /adds /significant /information /to /an /already /documented /serious /adverse
/event.
b) /A /report /of /interstitial /nephritis /in /a /patient /with /acute /renal /failure
c) /A /report /of /fulminant /hepatitis /in /patient /with /an /initial /report /of /hepatitis.
d) /All /of /the /above /- /verified /answer(s)-✔✔d) /All /of /the /above
For /expedited /reporting /an /event /must /be:
a) /Serious
b) /Serious /and /Unexpected /
c) /Only /temporally /associated /with /drug /administration
d) /Causally /related /to /drug /administration. /- /verified /answer(s)-✔✔b) /Serious /and
/Unexpected
According /to /ICH /serious /unexpected /reaction /to /a /drug /should /be:
a) /Submitted /to /the /appropriate /regulatory /authority /within /one /week.
b) /Submitted /to /the /appropriate /regulatory /authority /within /15 /days.
c) /Submitted /to /the /appropriate /regulatory /authority /on /an /expedited /basis.
d) /Submitted /promptly /to /the /IRB /- /verified /answer(s)-✔✔c) /Submitted /to /the /appropriate
/regulatory /authority /on /an /expedited /basis.
