ACRP CCRC EXAM PREP QUESTIONS AND CORRECT
ANSWERS
1. What are expected or possible consequences of over-
estimation of recruit- ment potential?: - 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
2.What should be the first consideration when conducting a
clinical trial?: -
Subject welfare
3. When is the investigator allowed to deviate from the
protocol?: When there is an immediate hazard to a patient.
4. 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?: - The Sponsor
- IRB/IEC
- Regulatory Authorities
5. Which conditions should be fulfilled when enrolling a
subject into your trial?: - Subject meets all inclusion criteria
- Subject has given written informed consent
6. 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?: - Contact the Sponsor, explain what happened and ask for
instructions
- Set up a site staff meeting to conduct a root cause analysis
7. 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?: No,
these subjects are still enrolled in the trial and therefore need to be
updated on any changes to the protocol.
8. A trial subject informs you she no longer wants to participant
in the trial. What should your course of action be?: 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.
, ACRP CCRC EXAM PREP QUESTIONS AND CORRECT
ANSWERS
9. 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?: You
attempt to retrieve the patients medical history by contacting previous
caregivers and you wait for additional information before enrollment.
10.Who has ultimate trial responsibility for each subject?: The
principle in- vestigator.
11.A trial subject suffers from severe repeat headaches. Should
this adverse event be reported to the IRB?: No
12.What statements are true concerning an adverse drug
reaction?: - 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
ANSWERS
1. What are expected or possible consequences of over-
estimation of recruit- ment potential?: - 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
2.What should be the first consideration when conducting a
clinical trial?: -
Subject welfare
3. When is the investigator allowed to deviate from the
protocol?: When there is an immediate hazard to a patient.
4. 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?: - The Sponsor
- IRB/IEC
- Regulatory Authorities
5. Which conditions should be fulfilled when enrolling a
subject into your trial?: - Subject meets all inclusion criteria
- Subject has given written informed consent
6. 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?: - Contact the Sponsor, explain what happened and ask for
instructions
- Set up a site staff meeting to conduct a root cause analysis
7. 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?: No,
these subjects are still enrolled in the trial and therefore need to be
updated on any changes to the protocol.
8. A trial subject informs you she no longer wants to participant
in the trial. What should your course of action be?: 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.
, ACRP CCRC EXAM PREP QUESTIONS AND CORRECT
ANSWERS
9. 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?: You
attempt to retrieve the patients medical history by contacting previous
caregivers and you wait for additional information before enrollment.
10.Who has ultimate trial responsibility for each subject?: The
principle in- vestigator.
11.A trial subject suffers from severe repeat headaches. Should
this adverse event be reported to the IRB?: No
12.What statements are true concerning an adverse drug
reaction?: - 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
