1|Page
ACRP-CP CERTIFICATION EXAM |COMPLETE QUESTIONS
WITH EXPERT SOLUTIONS | 2026 LATEST UPDATED | GET
A+
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
,2|Page
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 start up 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
,3|Page
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
, 4|Page
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
ACRP-CP CERTIFICATION EXAM |COMPLETE QUESTIONS
WITH EXPERT SOLUTIONS | 2026 LATEST UPDATED | GET
A+
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
,2|Page
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 start up 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
,3|Page
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
, 4|Page
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
