ACRP CCRC Exam Prep Questions and
Answers with Verified Solutions | Latest
Updated 2026
What are expected or possible - The trial will overrun its projected
consequences of timeline-The recruitment period will
over-estimation of recruitment be prolonged and more sites may be
potential? 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 Subject welfare
consideration when
conducting a clinical trial?
When is the investigator When there is an immediate hazard
allowed to deviate from the to a patient.
protocol?
If the investigator wanted to - The Sponsor-IRB/IEC-Regulatory
deviate from the protocol for Authorities
an immediate hazard to a
patient, according to ICH E6
guidelines who world they
need to report the deviation
and rationale to, if
appropriate?
Which conditions should be - Subject meets all inclusion
fulfilled when enrolling a criteria-Subject has given written
,subject into your trial? informed consent
You've been delegated to - Contact the Sponsor, explain what
handle the storage and happened and ask for
inventory of IP. The study drug instructions-Set up a site staff
must be stored below meeting to conduct a root cause
25C/77F. On a summer analysis
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?
A protocol amendment was No, these subjects are still enrolled
issued for a trial. Your site in the trial and therefore need to be
received IRB approval for the updated on any changes to the
amendment and wants to protocol.
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?
A trial subject informs you she You ask if the patient wishes to
no longer wants to participant share the reason why she wants to
in the trial. What should your leave the trial. If not, you exclude
course of action be? the subject from the trial
immediately.
A patient cannot recall the You attempt to retrieve the patients
name of the heart condition medical history by contacting
medication he took a few previous caregivers and you wait for
years ago. This is important additional information before
information for deciding enrollment.
whether the patient may be
enrolled in a clinical trial
(IC/EC). What's your best
course of action?
Who has ultimate trial The principle investigator.
responsibility for each subject?
A trial subject suffers from No
severe repeat headaches.
Should this adverse event be
reported to the IRB?
What statements are true - All noxious and unintended
concerning an adverse drug responses to a medicinal product
reaction? related to any dose should be
considered as an ADR-An ADR
suggests a relationship to trail
medication-All ADRs must be
Answers with Verified Solutions | Latest
Updated 2026
What are expected or possible - The trial will overrun its projected
consequences of timeline-The recruitment period will
over-estimation of recruitment be prolonged and more sites may be
potential? 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 Subject welfare
consideration when
conducting a clinical trial?
When is the investigator When there is an immediate hazard
allowed to deviate from the to a patient.
protocol?
If the investigator wanted to - The Sponsor-IRB/IEC-Regulatory
deviate from the protocol for Authorities
an immediate hazard to a
patient, according to ICH E6
guidelines who world they
need to report the deviation
and rationale to, if
appropriate?
Which conditions should be - Subject meets all inclusion
fulfilled when enrolling a criteria-Subject has given written
,subject into your trial? informed consent
You've been delegated to - Contact the Sponsor, explain what
handle the storage and happened and ask for
inventory of IP. The study drug instructions-Set up a site staff
must be stored below meeting to conduct a root cause
25C/77F. On a summer analysis
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?
A protocol amendment was No, these subjects are still enrolled
issued for a trial. Your site in the trial and therefore need to be
received IRB approval for the updated on any changes to the
amendment and wants to protocol.
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?
A trial subject informs you she You ask if the patient wishes to
no longer wants to participant share the reason why she wants to
in the trial. What should your leave the trial. If not, you exclude
course of action be? the subject from the trial
immediately.
A patient cannot recall the You attempt to retrieve the patients
name of the heart condition medical history by contacting
medication he took a few previous caregivers and you wait for
years ago. This is important additional information before
information for deciding enrollment.
whether the patient may be
enrolled in a clinical trial
(IC/EC). What's your best
course of action?
Who has ultimate trial The principle investigator.
responsibility for each subject?
A trial subject suffers from No
severe repeat headaches.
Should this adverse event be
reported to the IRB?
What statements are true - All noxious and unintended
concerning an adverse drug responses to a medicinal product
reaction? related to any dose should be
considered as an ADR-An ADR
suggests a relationship to trail
medication-All ADRs must be
