ACRP CCRA EXAM PREP/STUDY GUIDE EXAM
QUESTIONS AND CORRECT ANSWERS LATEST UPDATE
When is the investigator allowed to deviate from the protocol?
ANS >>>When there is an immediate hazard to a patient.
What should be the first consideration when conducting a clinical
trial? ANS >>>Subject welfare
What are expected or possible consequences of over-estimation
of recruitment potential? ANS >>>- 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
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? ANS >>>- The Sponsor
- IRB/IEC
- Regulatory Authorities
,Which conditions should be fulfilled when enrolling a
subject into your trial? ANS >>>- 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 don’t know what
the temperature has been over the weekend. You check the
current temperature; it's
,24C/75F. What should you do? ANS >>>- 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 who already
completed their drug intake period. Is this allowed according the
E6 Guideline for GCP? ANS >>>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? ANS >>>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? ANS >>>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? ANS >>>The
principal investigator.
A trial subject suffers from severe repeat headaches. Should this
adverse event be reported to the IRB? ANS >>>No
What statements are true concerning an adverse drug reaction?
ANS >>>- All noxious and unintended responses to a medicinal
product related to any dose should be considered as an ADR
QUESTIONS AND CORRECT ANSWERS LATEST UPDATE
When is the investigator allowed to deviate from the protocol?
ANS >>>When there is an immediate hazard to a patient.
What should be the first consideration when conducting a clinical
trial? ANS >>>Subject welfare
What are expected or possible consequences of over-estimation
of recruitment potential? ANS >>>- 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
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? ANS >>>- The Sponsor
- IRB/IEC
- Regulatory Authorities
,Which conditions should be fulfilled when enrolling a
subject into your trial? ANS >>>- 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 don’t know what
the temperature has been over the weekend. You check the
current temperature; it's
,24C/75F. What should you do? ANS >>>- 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 who already
completed their drug intake period. Is this allowed according the
E6 Guideline for GCP? ANS >>>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? ANS >>>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? ANS >>>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? ANS >>>The
principal investigator.
A trial subject suffers from severe repeat headaches. Should this
adverse event be reported to the IRB? ANS >>>No
What statements are true concerning an adverse drug reaction?
ANS >>>- All noxious and unintended responses to a medicinal
product related to any dose should be considered as an ADR
