ACRP-CP CERTIFICATION EXAM
|COMPLETE QUESTIONS MERGED WITH
CORRECT COMPLETE SOLUTIONS ||
ALREADY GRADED A+ || 2026-2027
LATEST UPDATE!!!
What would be the first priority for an investigator when a subject
wishes to withdraw prematurely from the trial? - ANSWER-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 - ANSWER-
Validation
Accuracy
Reliability
,Completeness
Part of a sponsor's responsibility pertaining to electronic trial data
handling is to - ANSWER-maintain an audit trail, data trail, and edit
trail.
A research subject's responsibilities for study participation should be
described in the - ANSWER-ICF
What document would an investigator reference to learn more about
the previous clinical and nonclinical results of studies of the IP? -
ANSWER-Investigators brochure
During a multi site clinical study: whose responsibility is it to report
subject recruitment rate? - ANSWER-The CRA
An unconscious adult subject was 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 - ANSWER-Obtain consent from the subject for the study
A site is in the startup phase of an industry sponsored phase 3 trial:
and has received IRB approval. The site can begin enrolling subjects
after... - ANSWER-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? - ANSWER-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? - ANSWER-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? - ANSWER-Confirm dates of
initial receipt of the sponsor protocol and the IRB submission dates.
In a multi arm: randomized clinical 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? - ANSWER-PI
Which of the following required elements should be included in a
clinical trial protocol? - ANSWER-Subject inclusion and exclusion
criteria
Prior to archiving a study: documentation of IP destruction at the site
should be filed in the study files of the - ANSWER-PI and Sponsor
During a monitoring visit: what records would a CRA reference to
verify a subject's compliance to the study visit schedule and
assessments? - ANSWER-Electronic medical record
When considering participation in a study: the investigator should
determine if he... - ANSWER-Sees enough patients who would qualify
for the study
, New safety information has become available from the Sponsor about
the IP being used in a clinical trial. The investigator must - ANSWER-
Submit a revised ICF to the IRB noting the new safety information
Per ICH: an IRB must keep correspondence for at least how long after
the completion of a clinical trial? - ANSWER-3 Years
When would an impartial witness be needed during the consent
process for an illiterate subject? - ANSWER-To observe the consent
process
A study which seeks to determine the ideal dose and regimen of a
new IP to treat hypothyroidism is considered to be - ANSWER-Phase II
After completion of a study: the final trial close out monitoring report
prepared by the CRA should be filed in which of the following
stakeholder files? - ANSWER-The sponsors files
A blood sample collection is required to screen for bloodborne
pathogens before subject could be enrolled in a study. Where will
subjects find information of the procedures and any foreseeable risks
or inconveniences? - ANSWER-ICF
When should a research study involving human subjects be registered
in a publicly accessible database? - ANSWER-Before recruiting the first
subject
In the case of an incapacitated subject: who should receive a copy of
the signed and dated ICF? - ANSWER-The subjects legally acceptable
representative
A medical student is approaches by a faculty member for possible
participation in a cricothyroidotomy simulation research study. Which
|COMPLETE QUESTIONS MERGED WITH
CORRECT COMPLETE SOLUTIONS ||
ALREADY GRADED A+ || 2026-2027
LATEST UPDATE!!!
What would be the first priority for an investigator when a subject
wishes to withdraw prematurely from the trial? - ANSWER-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 - ANSWER-
Validation
Accuracy
Reliability
,Completeness
Part of a sponsor's responsibility pertaining to electronic trial data
handling is to - ANSWER-maintain an audit trail, data trail, and edit
trail.
A research subject's responsibilities for study participation should be
described in the - ANSWER-ICF
What document would an investigator reference to learn more about
the previous clinical and nonclinical results of studies of the IP? -
ANSWER-Investigators brochure
During a multi site clinical study: whose responsibility is it to report
subject recruitment rate? - ANSWER-The CRA
An unconscious adult subject was 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 - ANSWER-Obtain consent from the subject for the study
A site is in the startup phase of an industry sponsored phase 3 trial:
and has received IRB approval. The site can begin enrolling subjects
after... - ANSWER-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? - ANSWER-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? - ANSWER-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? - ANSWER-Confirm dates of
initial receipt of the sponsor protocol and the IRB submission dates.
In a multi arm: randomized clinical 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? - ANSWER-PI
Which of the following required elements should be included in a
clinical trial protocol? - ANSWER-Subject inclusion and exclusion
criteria
Prior to archiving a study: documentation of IP destruction at the site
should be filed in the study files of the - ANSWER-PI and Sponsor
During a monitoring visit: what records would a CRA reference to
verify a subject's compliance to the study visit schedule and
assessments? - ANSWER-Electronic medical record
When considering participation in a study: the investigator should
determine if he... - ANSWER-Sees enough patients who would qualify
for the study
, New safety information has become available from the Sponsor about
the IP being used in a clinical trial. The investigator must - ANSWER-
Submit a revised ICF to the IRB noting the new safety information
Per ICH: an IRB must keep correspondence for at least how long after
the completion of a clinical trial? - ANSWER-3 Years
When would an impartial witness be needed during the consent
process for an illiterate subject? - ANSWER-To observe the consent
process
A study which seeks to determine the ideal dose and regimen of a
new IP to treat hypothyroidism is considered to be - ANSWER-Phase II
After completion of a study: the final trial close out monitoring report
prepared by the CRA should be filed in which of the following
stakeholder files? - ANSWER-The sponsors files
A blood sample collection is required to screen for bloodborne
pathogens before subject could be enrolled in a study. Where will
subjects find information of the procedures and any foreseeable risks
or inconveniences? - ANSWER-ICF
When should a research study involving human subjects be registered
in a publicly accessible database? - ANSWER-Before recruiting the first
subject
In the case of an incapacitated subject: who should receive a copy of
the signed and dated ICF? - ANSWER-The subjects legally acceptable
representative
A medical student is approaches by a faculty member for possible
participation in a cricothyroidotomy simulation research study. Which
