ACRP-CP CERTIFICATION EXAM |COMPLETE
QUESTIONS WITH EXPERT SOLUTIONS | 2026
LATEST UPDATED | GET A+
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Terms in this set (216)
What would be the first priority for Try to obtain the subject's reason for withdrawal.
an investigator when a subject
wishes to withdraw prematurely
from the trial?
CRO recently switched from paper Validation
CRF to an EDC system. The EDC Accuracy
system must conform to the Reliability
established requirements for Completeness
Part of a sponsor's responsibility maintain an audit trail, data trail, and edit trail.
pertaining to electronic trial data
handling is to
,A research subject's responsibilities ICF
for study participation should be
described in the
What document would an Investigators brochure
investigator reference to learn
more about the previous clinical
and nonclinical results of studies of
the IP?
During a multi site clinical study: The CRA
whose responsibility is it to report
subject recruitment rate?
An unconscious adult subject was Obtain consent from the subject for the study
enrolled in a study after obtaining
consent from an LAR: and protocol
therapy was initiated. The subject
showed significant improvement in
his clinical condition: and regained
consciousness. The Investigator
should inform the subject about the
study and
A site is in the start up phase of an A signed clinical trial agreement between the site
industry sponsored phase 3 trial: and sponsor is in place.
and has received IRB approval. The
site can begin enrolling subjects
after...
, A site is screening potential A research assistant who is certified to administer
subjects for a study looking at mild the psychometric test
cognitive impairment. One of the
inclusion criteria is a score of 25 or
less on a psychometric test: a
research specific tool which
measures cognitive ability. Which of
the following individuals can
administer the psychometric test to
the potential subjects?
A research study: in which there is Wording indicating that there is no expected
no intended clinical benefit to the benefit should be included
subject: is being submitted to the
IRB. What benefit information
should be included in the ICF?
A CRA notices during an onsite visit Confirm dates of initial receipt of the sponsor
that the date on IRB approval letter protocol and the IRB submission dates.
for a protocol is prior to the
effective date indicated on the
cover page of the protocol and the
signatures of the investigator and
sponsor. What should the CRA do
FIRST?
In a multi arm: randomized clinical PI
trial: one arm of the protocol was
terminated due to an increased risk
of cancer in subjects. Who is
responsible for providing a written
report to the IRB?
QUESTIONS WITH EXPERT SOLUTIONS | 2026
LATEST UPDATED | GET A+
Save
Terms in this set (216)
What would be the first priority for Try to obtain the subject's reason for withdrawal.
an investigator when a subject
wishes to withdraw prematurely
from the trial?
CRO recently switched from paper Validation
CRF to an EDC system. The EDC Accuracy
system must conform to the Reliability
established requirements for Completeness
Part of a sponsor's responsibility maintain an audit trail, data trail, and edit trail.
pertaining to electronic trial data
handling is to
,A research subject's responsibilities ICF
for study participation should be
described in the
What document would an Investigators brochure
investigator reference to learn
more about the previous clinical
and nonclinical results of studies of
the IP?
During a multi site clinical study: The CRA
whose responsibility is it to report
subject recruitment rate?
An unconscious adult subject was Obtain consent from the subject for the study
enrolled in a study after obtaining
consent from an LAR: and protocol
therapy was initiated. The subject
showed significant improvement in
his clinical condition: and regained
consciousness. The Investigator
should inform the subject about the
study and
A site is in the start up phase of an A signed clinical trial agreement between the site
industry sponsored phase 3 trial: and sponsor is in place.
and has received IRB approval. The
site can begin enrolling subjects
after...
, A site is screening potential A research assistant who is certified to administer
subjects for a study looking at mild the psychometric test
cognitive impairment. One of the
inclusion criteria is a score of 25 or
less on a psychometric test: a
research specific tool which
measures cognitive ability. Which of
the following individuals can
administer the psychometric test to
the potential subjects?
A research study: in which there is Wording indicating that there is no expected
no intended clinical benefit to the benefit should be included
subject: is being submitted to the
IRB. What benefit information
should be included in the ICF?
A CRA notices during an onsite visit Confirm dates of initial receipt of the sponsor
that the date on IRB approval letter protocol and the IRB submission dates.
for a protocol is prior to the
effective date indicated on the
cover page of the protocol and the
signatures of the investigator and
sponsor. What should the CRA do
FIRST?
In a multi arm: randomized clinical PI
trial: one arm of the protocol was
terminated due to an increased risk
of cancer in subjects. Who is
responsible for providing a written
report to the IRB?