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ACRP-CP Certification Exam
Questions and Correct Answers
Already Graded (2025)
What would be the first priority for an investigator when a subject
wishes to withdraw prematurely from the trial?
Ans: Try to obtain the subject's reason for withdrawal.
CRO recently switched from paper CRF to an EDC system. The EDC
system must conform to the established requirements for
Ans: Validation
Accuracy
Reliability
Completeness
Part of a sponsor's responsibility pertaining to electronic trial data
handling is to
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Ans: maintain an audit trail, data trail, and edit trail.
A research subject's responsibilities for study participation should be
described in the
Ans: ICF
What document would an investigator reference to learn more
about the previous clinical and nonclinical results of studies of the IP?
Ans: Investigators brochure
During a multi site clinical study: whose responsibility is it to report
subject recruitment rate?
Ans: The CRA
An unconscious adult subject was enrolled in a study after obtaining
consent from an LAR: and protocol therapy was initiated. The
,3|Page
subject showed significant improvement in his clinical condition: and
regained consciousness. The Investigator should inform the subject
about the study and
Ans: Obtain consent from the subject for the study
A site is in the start up phase of an industry sponsored phase 3 trial:
and has received IRB approval. The site can begin enrolling subjects
after...
Ans: A signed clinical trial agreement between the site and sponsor is in
place.
A site is screening potential subjects for a study looking at mild
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?
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Ans: A research assistant who is certified to administer the psychometric
test
A research study: in which there is no intended clinical benefit to the
subject: is being submitted to the IRB. What benefit information
should be included in the ICF?
Ans: Wording indicating that there is no expected benefit should be
included
A CRA notices during an onsite visit that the date on IRB approval
letter 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?
Ans: Confirm dates of initial receipt of the sponsor protocol and the IRB
submission dates.
ACRP-CP Certification Exam
Questions and Correct Answers
Already Graded (2025)
What would be the first priority for an investigator when a subject
wishes to withdraw prematurely from the trial?
Ans: Try to obtain the subject's reason for withdrawal.
CRO recently switched from paper CRF to an EDC system. The EDC
system must conform to the established requirements for
Ans: Validation
Accuracy
Reliability
Completeness
Part of a sponsor's responsibility pertaining to electronic trial data
handling is to
,2|Page
Ans: maintain an audit trail, data trail, and edit trail.
A research subject's responsibilities for study participation should be
described in the
Ans: ICF
What document would an investigator reference to learn more
about the previous clinical and nonclinical results of studies of the IP?
Ans: Investigators brochure
During a multi site clinical study: whose responsibility is it to report
subject recruitment rate?
Ans: The CRA
An unconscious adult subject was enrolled in a study after obtaining
consent from an LAR: and protocol therapy was initiated. The
,3|Page
subject showed significant improvement in his clinical condition: and
regained consciousness. The Investigator should inform the subject
about the study and
Ans: Obtain consent from the subject for the study
A site is in the start up phase of an industry sponsored phase 3 trial:
and has received IRB approval. The site can begin enrolling subjects
after...
Ans: A signed clinical trial agreement between the site and sponsor is in
place.
A site is screening potential subjects for a study looking at mild
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?
, 4|Page
Ans: A research assistant who is certified to administer the psychometric
test
A research study: in which there is no intended clinical benefit to the
subject: is being submitted to the IRB. What benefit information
should be included in the ICF?
Ans: Wording indicating that there is no expected benefit should be
included
A CRA notices during an onsite visit that the date on IRB approval
letter 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?
Ans: Confirm dates of initial receipt of the sponsor protocol and the IRB
submission dates.
