ACRP CCRC EXAM PREP QUESTIONS AND CORRECT AN
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SWERS
1. What are expected or possible consequences of over-
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h estimation of recruit- ment potential?: -
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The trial will overrun its projected timeline
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- The recruitment period will be prolonged and more sites may be ne
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eded
- The study will not have sufficient data within the required timeframe an
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d will be stopped because of lack of budget
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2. What should be the first consideration when conducting a c
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linical trial?: - h h
Subject welfare h
3. When is the investigator allowed to deviate from the p
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rotocol?: When there is an immediate hazard to a patient.
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4. If the investigator wanted to deviate from the protocol for a
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n immediate hazard to a patient, according to ICH E6
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guidelines who world they need to report the deviation and
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,rationale to, if appropriate?: - The Sponsor
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- IRB/IEC
- Regulatory Authorities h
5. Which conditions should be fulfilled when enrolling a su
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bject into your trial?: - Subject meets all inclusion criteria
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- Subject has given written informed consent
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6. You've been delegated to handle the storage and inventory of I
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P.The study drug must be stored below 25C/77F. On a summer
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Monday morning you discover that the temperature recording m
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achine in the storage room has failed so you doin't know what th
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e temperature has been over the weekend. You check the curren
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t temperature; it's 24C/75F. What should you do?: -
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h Contact the Sponsor, explain what happened and ask for instructions
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- Set up a site staff meeting to conduct a root cause analysis
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7. A protocol amendment was issued for a trial. Your site recei
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ved IRB approval for the amendment and wants to implemen
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t the increase in PO dose for your trial subjects as identified in
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h the amendment trial subjects. As delegated
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,consenting duties you must re- h h h h
consent trial subjects before being able to administer the adjust
h h h h h h h h h
ed dose. You decide to only re-
h h h h h h
consent trial subjects who are still taking the IP and not from th
h h h h h h h h h h h h
e subjects woh already completed their drug intake period. Is thi
h h h h h h h h h h
s allowed according the E6 Guideline for GCP?: No, these subjects a
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re still enrolled in the trial and therefore need to be updated on any chang
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es to the protocol.
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8. A trial subject informs you she no longer wants to participant in
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h the trial. What should your course of action be?: You ask if the patie
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nt wishes to share the reason why she wants to leave the trial. If not, you
h h h h h h h h h h h h h h h h
exclude the subject from the trial immediately.
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1h/h26
, ACRP CCRC EXAM PREP QUESTIONS AND CORRECT AN
h h h h h h h
SWERS
9. A patient cannot recall the name of the heart condition medicat
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ion he took a few years ago. This is important information for deci
h h h h h h h h h h h h
ding whether the patient may be enrolled in a clinical trial (IC/EC
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). What's your best course of action?: You attempt to retrieve the pati
h h h h h h h h h h h h
ents medical history by contacting previous caregivers and you wait for ad
h h h h h h h h h h h
ditional information before enrollment. h h h
10. Who has ultimate trial responsibility for each subject?: The p
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rinciple in- vestigator. h h
11. A trial subject suffers from severe repeat headaches. Should t
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his adverse event be reported to the IRB?: No
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12. What statements are true concerning an adverse drug react
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ion?: - h
h All noxious and unintended responses to a medicinal product related t
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o any dose should be considered as an ADR
h h h h h h h h
- An ADR suggests a relationship to trail medication
h h h h h h h
h h h h h h h
SWERS
1. What are expected or possible consequences of over-
h h h h h h h
h estimation of recruit- ment potential?: -
h h h h h
The trial will overrun its projected timeline
h h h h h h h
- The recruitment period will be prolonged and more sites may be ne
h h h h h h h h h h h
eded
- The study will not have sufficient data within the required timeframe an
h h h h h h h h h h h
d will be stopped because of lack of budget
h h h h h h h h
2. What should be the first consideration when conducting a c
h h h h h h h h h
linical trial?: - h h
Subject welfare h
3. When is the investigator allowed to deviate from the p
h h h h h h h h h
rotocol?: When there is an immediate hazard to a patient.
h h h h h h h h h
4. If the investigator wanted to deviate from the protocol for a
h h h h h h h h h h
n immediate hazard to a patient, according to ICH E6
h h h h h h h h h
guidelines who world they need to report the deviation and
h h h h h h h h h
,rationale to, if appropriate?: - The Sponsor
h h h h h h
- IRB/IEC
- Regulatory Authorities h
5. Which conditions should be fulfilled when enrolling a su
h h h h h h h h
bject into your trial?: - Subject meets all inclusion criteria
h h h h h h h h h
- Subject has given written informed consent
h h h h h
6. You've been delegated to handle the storage and inventory of I
h h h h h h h h h h
P.The study drug must be stored below 25C/77F. On a summer
h h h h h h h h h h h
Monday morning you discover that the temperature recording m
h h h h h h h h
achine in the storage room has failed so you doin't know what th
h h h h h h h h h h h h
e temperature has been over the weekend. You check the curren
h h h h h h h h h h
t temperature; it's 24C/75F. What should you do?: -
h h h h h h h h
h Contact the Sponsor, explain what happened and ask for instructions
h h h h h h h h h
- Set up a site staff meeting to conduct a root cause analysis
h h h h h h h h h h h
7. A protocol amendment was issued for a trial. Your site recei
h h h h h h h h h h
ved IRB approval for the amendment and wants to implemen
h h h h h h h h h
t the increase in PO dose for your trial subjects as identified in
h h h h h h h h h h h h
h the amendment trial subjects. As delegated
h h h h h
,consenting duties you must re- h h h h
consent trial subjects before being able to administer the adjust
h h h h h h h h h
ed dose. You decide to only re-
h h h h h h
consent trial subjects who are still taking the IP and not from th
h h h h h h h h h h h h
e subjects woh already completed their drug intake period. Is thi
h h h h h h h h h h
s allowed according the E6 Guideline for GCP?: No, these subjects a
h h h h h h h h h h h
re still enrolled in the trial and therefore need to be updated on any chang
h h h h h h h h h h h h h h
es to the protocol.
h h h
8. A trial subject informs you she no longer wants to participant in
h h h h h h h h h h h
h the trial. What should your course of action be?: You ask if the patie
h h h h h h h h h h h h h
nt wishes to share the reason why she wants to leave the trial. If not, you
h h h h h h h h h h h h h h h h
exclude the subject from the trial immediately.
h h h h h h
1h/h26
, ACRP CCRC EXAM PREP QUESTIONS AND CORRECT AN
h h h h h h h
SWERS
9. A patient cannot recall the name of the heart condition medicat
h h h h h h h h h h
ion he took a few years ago. This is important information for deci
h h h h h h h h h h h h
ding whether the patient may be enrolled in a clinical trial (IC/EC
h h h h h h h h h h h
). What's your best course of action?: You attempt to retrieve the pati
h h h h h h h h h h h h
ents medical history by contacting previous caregivers and you wait for ad
h h h h h h h h h h h
ditional information before enrollment. h h h
10. Who has ultimate trial responsibility for each subject?: The p
h h h h h h h h h
rinciple in- vestigator. h h
11. A trial subject suffers from severe repeat headaches. Should t
h h h h h h h h h
his adverse event be reported to the IRB?: No
h h h h h h h h
12. What statements are true concerning an adverse drug react
h h h h h h h h
ion?: - h
h All noxious and unintended responses to a medicinal product related t
h h h h h h h h h h
o any dose should be considered as an ADR
h h h h h h h h
- An ADR suggests a relationship to trail medication
h h h h h h h
