ACRP CCRC Exam Prep Questions With
Correct Answers
What /are /expected /or /possible /consequences /of /over-estimation /of /recruitment /potential? /-
correct /answer(s) /✔✔ /- /The /trial /will /overrun /its /projected /timeline
/
- /The /recruitment /period /will /be /prolonged /and /more /sites /may /be /needed
- /The /study /will /not /have /sufficient /data /within /the /required /timeframe /and /will /be /stopped
/because /of /lack /of /budget
What /should /be /the /first /consideration /when /conducting /a /clinical /trial? /- /correct /answer(s)
✔✔ /Subject /welfare
/
When /is /the /investigator /allowed /to /deviate /from /the /protocol? /- /correct /answer(s) /✔✔
/When /there /is /an /immediate /hazard /to /a /patient.
If /the /investigator /wanted /to /deviate /from /the /protocol /for /an /immediate /hazard /to /a
/patient, /according /to /ICH /E6 /guidelines /who /world /they /need /to /report /the /deviation /and
rationale /to, /if /appropriate? /- /correct /answer(s) /✔✔ /- /The /Sponsor
/
- /IRB/IEC
- /Regulatory /Authorities
Which /conditions /should /be /fulfilled /when /enrolling /a /subject /into /your /trial? /- /correct
answer(s) /✔✔ /- /Subject /meets /all /inclusion /criteria
/
- /Subject /has /given /written /informed /consent
,You've /been /delegated /to /handle /the /storage /and /inventory /of /IP. /The /study /drug /must /be
/stored /below /25C/77F. /On /a /summer /Monday /morning /you /discover /that /the /temperature
/recording /machine /in /the /storage /room /has /failed /so /you /doin't /know /what /the /temperature
/has /been /over /the /weekend. /You /check /the /current /temperature; /it's /24C/75F. /What /should
/you /do? /- /correct /answer(s) /✔✔ /- /Contact /the /Sponsor, /explain /what /happened /and /ask /for
/instructions
- /Set /up /a /site /staff /meeting /to /conduct /a /root /cause /analysis
A /protocol /amendment /was /issued /for /a /trial. /Your /site /received /IRB /approval /for /the
/amendment /and /wants /to /implement /the /increase /in /PO /dose /for /your /trial /subjects /as
/identified /in /the /amendment /trial /subjects. /As /delegated /consenting /duties /you /must /re-
consent /trial /subjects /before /being /able /to /administer /the /adjusted /dose. /You /decide /to /only
/re-consent /trial /subjects /who /are /still /taking /the /IP /and /not /from /the /subjects /woh /already
/completed /their /drug /intake /period. /Is /this /allowed /according /the /E6 /Guideline /for /GCP? /-
/correct /answer(s) /✔✔ /No, /these /subjects /are /still /enrolled /in /the /trial /and /therefore /need /to
/be /updated /on /any /changes /to /the /protocol.
A /trial /subject /informs /you /she /no /longer /wants /to /participant /in /the /trial. /What /should /your
/course /of /action /be? /- /correct /answer(s) /✔✔ /You /ask /if /the /patient /wishes /to /share /the
/reason /why /she /wants /to /leave /the /trial. /If /not, /you /exclude /the /subject /from /the /trial
/immediately.
A /patient /cannot /recall /the /name /of /the /heart /condition /medication /he /took /a /few /years /ago.
/This /is /important /information /for /deciding /whether /the /patient /may /be /enrolled /in /a /clinical
/trial /(IC/EC). /What's /your /best /course /of /action? /- /correct /answer(s) /✔✔ /You /attempt /to
/retrieve /the /patients /medical /history /by /contacting /previous /caregivers /and /you /wait /for
/additional /information /before /enrollment.
Who /has /ultimate /trial /responsibility /for /each /subject? /- /correct /answer(s) /✔✔ /The /principle
/investigator.
,A /trial /subject /suffers /from /severe /repeat /headaches. /Should /this /adverse /event /be /reported
to /the /IRB? /- /correct /answer(s) /✔✔ /No
/
What /statements /are /true /concerning /an /adverse /drug /reaction? /- /correct /answer(s) /✔✔ /- /All
/noxious /and /unintended /responses /to /a /medicinal /product /related /to /any /dose /should /be
/considered /as /an /ADR
- /An /ADR /suggests /a /relationship /to /trail /medication
- /All /ADRs /must /be /documented
What /Adverse /Events /(AEs) /are /Serious /Adverse /Events /(SAEs)? /- /correct /answer(s) /✔✔ /- /Any
/AE /that /results /in /death
- /Any /AE /that /results /in /inpatient /hospitalization
- /Any /AE /that /is /a /congenital /anomaly
During /a /study /visit /a /patient /tells /the /investigator /that /she /visited /an /emergency /room /and
/received /intensive /treatment /for /allergic /bronchospasm. /Since /the /patient /was /in /the
/emergency /room /for /only /three /hours, /the /investigator /did /not /assess /the /event /as /serious.
/Is /this /a /correct /assessment? /- /correct /answer(s) /✔✔ /No, /this /would /be /a /medically
/important /event /and /should /be /considered /serious
What /data /points /minimally /need /to /be /reported /by /the /site /when /reporting /an /SAE, /so /that
/the /sponsor /can /process /the /event? /- /correct /answer(s) /✔✔ /Identification /of /event, /product,
/and /trial /subject
During /a /visit /with /investigator, /a /subject /reported /feeling /heart /palpitations /for /a /brief
/period /of /time /during /the /previous /evening. /The /heart /palpitations /resolved /without
/reoccurrence. /The /investigator /considered /these /symptoms /to /be /unrelated /to /study /drug.
/The /next /day, /the /subject /told /a /fellow /student /that /he /felt /tired /and /was /planning /on /taking
/a /nap. /Later, /the /subject /was /found /dead. /A /preliminary /report /from /the /medical /examiner
/indicated /the /subject /died /of /pulmonary /embolism. /What /should /your /next /course /of /action
be? /- /correct /answer(s) /✔✔ /- /Record /these /events /in /case /report /form
/
, - /Immediately /notify /sponsor /about /serious /adverse /events
When /asked /by /a /regulatory /body /why /they /received /SAE /related /information /on /12/2013
/from /an /incident /that /occurred /in /5/2013, /the /sponsor /explained /the /reason /being /they
/received /the /trial /related /SAE /information /from /the /investigator /in /12/2013. /Is /the /sponsor
/correct /in /only /holding /the /investigator /accountable /for /their /late /reporting? /- /correct
/answer(s) /✔✔ /No, /the /sponsor /should /support /the /conduct /QC /activities /with /the /sites /to
/help /them /ensure /timely /SAE /reporting.
A /trial /subject /in /a /cardiology /trial /is /admitted /to /hospital /with /heart /attack. /The /investigator
/considers /this /event /possibly /related /to /the /study /drug /even /though /this /is /not /listed /in /the
/IB /as /a /potential /adverse /reaction. /What /would /the /investigator /report /this /event /to /the
sponsor /as? /- /correct /answer(s) /✔✔ /An /unexpected, /serious /adverse /event
/
A /22y/o /male /was /entered /into /a /clinical /study /for /treatment /of /schizophrenia /The /study
/drug /was /administered /orally, /BID. /One /week /later, /the /subject /visited /the /investigator
/complaining /of /sever /sore /throat. /The /IB /lists /this /as /an /occurrence /reported /by /1% /of
/subjects /receiving /drug. /How /should /this /severe /throat /be /classified? /- /correct /answer(s) /✔✔
/- /An /adverse /event
- /An /adverse /drug /reaction
In /regards /to /AE /and /ADR /reporting, /what /statements /are /true? /- /correct /answer(s) /✔✔ /- /All
/ADRs /are /AEs /but /not /all /AEs /are /ADRs
- /Worsening /in /pre-existing /medical /conditions /is /an /AE
-Preplanned /hospitalization /is /usually /not /an /SAE
What /determines /the /causality /of /an /adverse /event? /- /correct /answer(s) /✔✔ /The /investigator
Which /term /best /describes /the /cyclical /process /that /involves /the /Plan, /Do, /Check, /Act
activities? /- /correct /answer(s) /✔✔ /Quality /improvement
/
Correct Answers
What /are /expected /or /possible /consequences /of /over-estimation /of /recruitment /potential? /-
correct /answer(s) /✔✔ /- /The /trial /will /overrun /its /projected /timeline
/
- /The /recruitment /period /will /be /prolonged /and /more /sites /may /be /needed
- /The /study /will /not /have /sufficient /data /within /the /required /timeframe /and /will /be /stopped
/because /of /lack /of /budget
What /should /be /the /first /consideration /when /conducting /a /clinical /trial? /- /correct /answer(s)
✔✔ /Subject /welfare
/
When /is /the /investigator /allowed /to /deviate /from /the /protocol? /- /correct /answer(s) /✔✔
/When /there /is /an /immediate /hazard /to /a /patient.
If /the /investigator /wanted /to /deviate /from /the /protocol /for /an /immediate /hazard /to /a
/patient, /according /to /ICH /E6 /guidelines /who /world /they /need /to /report /the /deviation /and
rationale /to, /if /appropriate? /- /correct /answer(s) /✔✔ /- /The /Sponsor
/
- /IRB/IEC
- /Regulatory /Authorities
Which /conditions /should /be /fulfilled /when /enrolling /a /subject /into /your /trial? /- /correct
answer(s) /✔✔ /- /Subject /meets /all /inclusion /criteria
/
- /Subject /has /given /written /informed /consent
,You've /been /delegated /to /handle /the /storage /and /inventory /of /IP. /The /study /drug /must /be
/stored /below /25C/77F. /On /a /summer /Monday /morning /you /discover /that /the /temperature
/recording /machine /in /the /storage /room /has /failed /so /you /doin't /know /what /the /temperature
/has /been /over /the /weekend. /You /check /the /current /temperature; /it's /24C/75F. /What /should
/you /do? /- /correct /answer(s) /✔✔ /- /Contact /the /Sponsor, /explain /what /happened /and /ask /for
/instructions
- /Set /up /a /site /staff /meeting /to /conduct /a /root /cause /analysis
A /protocol /amendment /was /issued /for /a /trial. /Your /site /received /IRB /approval /for /the
/amendment /and /wants /to /implement /the /increase /in /PO /dose /for /your /trial /subjects /as
/identified /in /the /amendment /trial /subjects. /As /delegated /consenting /duties /you /must /re-
consent /trial /subjects /before /being /able /to /administer /the /adjusted /dose. /You /decide /to /only
/re-consent /trial /subjects /who /are /still /taking /the /IP /and /not /from /the /subjects /woh /already
/completed /their /drug /intake /period. /Is /this /allowed /according /the /E6 /Guideline /for /GCP? /-
/correct /answer(s) /✔✔ /No, /these /subjects /are /still /enrolled /in /the /trial /and /therefore /need /to
/be /updated /on /any /changes /to /the /protocol.
A /trial /subject /informs /you /she /no /longer /wants /to /participant /in /the /trial. /What /should /your
/course /of /action /be? /- /correct /answer(s) /✔✔ /You /ask /if /the /patient /wishes /to /share /the
/reason /why /she /wants /to /leave /the /trial. /If /not, /you /exclude /the /subject /from /the /trial
/immediately.
A /patient /cannot /recall /the /name /of /the /heart /condition /medication /he /took /a /few /years /ago.
/This /is /important /information /for /deciding /whether /the /patient /may /be /enrolled /in /a /clinical
/trial /(IC/EC). /What's /your /best /course /of /action? /- /correct /answer(s) /✔✔ /You /attempt /to
/retrieve /the /patients /medical /history /by /contacting /previous /caregivers /and /you /wait /for
/additional /information /before /enrollment.
Who /has /ultimate /trial /responsibility /for /each /subject? /- /correct /answer(s) /✔✔ /The /principle
/investigator.
,A /trial /subject /suffers /from /severe /repeat /headaches. /Should /this /adverse /event /be /reported
to /the /IRB? /- /correct /answer(s) /✔✔ /No
/
What /statements /are /true /concerning /an /adverse /drug /reaction? /- /correct /answer(s) /✔✔ /- /All
/noxious /and /unintended /responses /to /a /medicinal /product /related /to /any /dose /should /be
/considered /as /an /ADR
- /An /ADR /suggests /a /relationship /to /trail /medication
- /All /ADRs /must /be /documented
What /Adverse /Events /(AEs) /are /Serious /Adverse /Events /(SAEs)? /- /correct /answer(s) /✔✔ /- /Any
/AE /that /results /in /death
- /Any /AE /that /results /in /inpatient /hospitalization
- /Any /AE /that /is /a /congenital /anomaly
During /a /study /visit /a /patient /tells /the /investigator /that /she /visited /an /emergency /room /and
/received /intensive /treatment /for /allergic /bronchospasm. /Since /the /patient /was /in /the
/emergency /room /for /only /three /hours, /the /investigator /did /not /assess /the /event /as /serious.
/Is /this /a /correct /assessment? /- /correct /answer(s) /✔✔ /No, /this /would /be /a /medically
/important /event /and /should /be /considered /serious
What /data /points /minimally /need /to /be /reported /by /the /site /when /reporting /an /SAE, /so /that
/the /sponsor /can /process /the /event? /- /correct /answer(s) /✔✔ /Identification /of /event, /product,
/and /trial /subject
During /a /visit /with /investigator, /a /subject /reported /feeling /heart /palpitations /for /a /brief
/period /of /time /during /the /previous /evening. /The /heart /palpitations /resolved /without
/reoccurrence. /The /investigator /considered /these /symptoms /to /be /unrelated /to /study /drug.
/The /next /day, /the /subject /told /a /fellow /student /that /he /felt /tired /and /was /planning /on /taking
/a /nap. /Later, /the /subject /was /found /dead. /A /preliminary /report /from /the /medical /examiner
/indicated /the /subject /died /of /pulmonary /embolism. /What /should /your /next /course /of /action
be? /- /correct /answer(s) /✔✔ /- /Record /these /events /in /case /report /form
/
, - /Immediately /notify /sponsor /about /serious /adverse /events
When /asked /by /a /regulatory /body /why /they /received /SAE /related /information /on /12/2013
/from /an /incident /that /occurred /in /5/2013, /the /sponsor /explained /the /reason /being /they
/received /the /trial /related /SAE /information /from /the /investigator /in /12/2013. /Is /the /sponsor
/correct /in /only /holding /the /investigator /accountable /for /their /late /reporting? /- /correct
/answer(s) /✔✔ /No, /the /sponsor /should /support /the /conduct /QC /activities /with /the /sites /to
/help /them /ensure /timely /SAE /reporting.
A /trial /subject /in /a /cardiology /trial /is /admitted /to /hospital /with /heart /attack. /The /investigator
/considers /this /event /possibly /related /to /the /study /drug /even /though /this /is /not /listed /in /the
/IB /as /a /potential /adverse /reaction. /What /would /the /investigator /report /this /event /to /the
sponsor /as? /- /correct /answer(s) /✔✔ /An /unexpected, /serious /adverse /event
/
A /22y/o /male /was /entered /into /a /clinical /study /for /treatment /of /schizophrenia /The /study
/drug /was /administered /orally, /BID. /One /week /later, /the /subject /visited /the /investigator
/complaining /of /sever /sore /throat. /The /IB /lists /this /as /an /occurrence /reported /by /1% /of
/subjects /receiving /drug. /How /should /this /severe /throat /be /classified? /- /correct /answer(s) /✔✔
/- /An /adverse /event
- /An /adverse /drug /reaction
In /regards /to /AE /and /ADR /reporting, /what /statements /are /true? /- /correct /answer(s) /✔✔ /- /All
/ADRs /are /AEs /but /not /all /AEs /are /ADRs
- /Worsening /in /pre-existing /medical /conditions /is /an /AE
-Preplanned /hospitalization /is /usually /not /an /SAE
What /determines /the /causality /of /an /adverse /event? /- /correct /answer(s) /✔✔ /The /investigator
Which /term /best /describes /the /cyclical /process /that /involves /the /Plan, /Do, /Check, /Act
activities? /- /correct /answer(s) /✔✔ /Quality /improvement
/
