ACRP CP CERTIFICATION Verified Exam Questions and Answers
Latest update 2026/2027
Question:
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.
Question:
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
Question:
Part of a sponsor's responsibility pertaining to electronic trial data handling is to
Answer:
maintain an audit trail, data trail, and edit trail.
Question:
A research subject's responsibilities for study participation should be described in the
Answer:
ICF
Question:
What document would an investigator reference to learn more about the previous clinical and
nonclinical results of studies of the IP?
Answer:
Investigators brochure
Question:
During a multi site clinical study: whose responsibility is it to report subject recruitment rate?
Answer:
The CRA
,Question:
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
Question:
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.
Question:
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
Question:
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
Question:
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.
Question:
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
,Question:
Which of the following required elements should be included in a clinical trial protocol?
Answer:
Subject inclusion and exclusion criteria
Question:
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
Question:
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
Question:
When considering participation in a study: the investigator should determine if he...
Answer:
Sees enough patients who would qualify for the study
Question:
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
Question:
Per ICH: an IRB must keep correspondence for at least how long after the completion of a clinical
trial?
Answer:
3 Years
Question:
When would an impartial witness be needed during the consent process for an illiterate subject?
Answer:
To observe the consent process
, Question:
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
Question:
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
Question:
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
Question:
When should a research study involving human subjects be registered in a publicly accessible
database?
Answer:
Before recruiting the first subject
Question:
In the case of an incapacitated subject: who should receive a copy of the signed and dated ICF?
Answer:
The subjects legally acceptable representative
Question:
A medical student is approaches by a faculty member for possible participation in a cricothyroidotomy
simulation research study. Which of the following increases risk to the study?
Answer:
Consenting in the presence of figure of authority
Latest update 2026/2027
Question:
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.
Question:
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
Question:
Part of a sponsor's responsibility pertaining to electronic trial data handling is to
Answer:
maintain an audit trail, data trail, and edit trail.
Question:
A research subject's responsibilities for study participation should be described in the
Answer:
ICF
Question:
What document would an investigator reference to learn more about the previous clinical and
nonclinical results of studies of the IP?
Answer:
Investigators brochure
Question:
During a multi site clinical study: whose responsibility is it to report subject recruitment rate?
Answer:
The CRA
,Question:
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
Question:
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.
Question:
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
Question:
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
Question:
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.
Question:
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
,Question:
Which of the following required elements should be included in a clinical trial protocol?
Answer:
Subject inclusion and exclusion criteria
Question:
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
Question:
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
Question:
When considering participation in a study: the investigator should determine if he...
Answer:
Sees enough patients who would qualify for the study
Question:
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
Question:
Per ICH: an IRB must keep correspondence for at least how long after the completion of a clinical
trial?
Answer:
3 Years
Question:
When would an impartial witness be needed during the consent process for an illiterate subject?
Answer:
To observe the consent process
, Question:
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
Question:
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
Question:
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
Question:
When should a research study involving human subjects be registered in a publicly accessible
database?
Answer:
Before recruiting the first subject
Question:
In the case of an incapacitated subject: who should receive a copy of the signed and dated ICF?
Answer:
The subjects legally acceptable representative
Question:
A medical student is approaches by a faculty member for possible participation in a cricothyroidotomy
simulation research study. Which of the following increases risk to the study?
Answer:
Consenting in the presence of figure of authority
