ACRP-CP Certification Exam (Anwered)
216 Q&A. 2025/2026, 100% Verified.
What would be the first priority for an investigator when a subject wishes to withdraw prematurely
from the trial?
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
Validation
Accuracy
Reliability
Completeness
Part of a sponsor's responsibility pertaining to electronic trial data handling is to
maintain an audit trail, data trail, and edit trail.
A research subject's responsibilities for study participation should be described in the
ICF
What document would an investigator reference to learn more about the previous clinical and
nonclinical results of studies of the IP?
Investigators brochure
During a multi site clinical study: whose responsibility is it to report subject recruitment rate?
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
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...
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?
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?
,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?
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?
PI
Which of the following required elements should be included in a clinical trial protocol?
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
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?
Electronic medical record
When considering participation in a study: the investigator should determine if he...
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
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?
3 Years
When would an impartial witness be needed during the consent process for an illiterate subject?
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
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?
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?
, ICF
When should a research study involving human subjects be registered in a publicly accessible
database?
Before recruiting the first subject
In the case of an incapacitated subject: who should receive a copy of the signed and dated ICF?
The subjects legally acceptable representative
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?
Consenting in the presence of figure of authority
The clinical trial phase that focuses on safety and human pharmacology in healthy volunteers
Phase I
Who is ultimately responsible for all aspects of the research conducted at a site?
Principal investigator
An international quality standard that is provided by ICH E6(R2) describing safety: accuracy of trials
and credibility of data
GCP
What event resulted in the Nuremburg Cod of 1949
Nazi Medical Experiments
Prior to archiving a study: documentation of IP destruction at the site should be filed in the study
files of the
PI and Sponsor
In the case of an incapacitated subject: who should receive a copy of the signed and dated ICF?
The subject's legally acceptable representative
Which of the following required elements should be included in a clinical trial protocol?
The subject inclusion and exclusion criteria
During a multi-site clinical study: whose responsibility is it to report subject recruitment rate?
The CRA
A study which seeks to determine the ideal dose and regimen of a new IP to treat hypothyroidism is
considered to be
Phase II
What document would an investigator reference to learn more about the previous clinical and
nonclinical results of studies of the IP?
IB
216 Q&A. 2025/2026, 100% Verified.
What would be the first priority for an investigator when a subject wishes to withdraw prematurely
from the trial?
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
Validation
Accuracy
Reliability
Completeness
Part of a sponsor's responsibility pertaining to electronic trial data handling is to
maintain an audit trail, data trail, and edit trail.
A research subject's responsibilities for study participation should be described in the
ICF
What document would an investigator reference to learn more about the previous clinical and
nonclinical results of studies of the IP?
Investigators brochure
During a multi site clinical study: whose responsibility is it to report subject recruitment rate?
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
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...
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?
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?
,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?
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?
PI
Which of the following required elements should be included in a clinical trial protocol?
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
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?
Electronic medical record
When considering participation in a study: the investigator should determine if he...
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
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?
3 Years
When would an impartial witness be needed during the consent process for an illiterate subject?
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
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?
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?
, ICF
When should a research study involving human subjects be registered in a publicly accessible
database?
Before recruiting the first subject
In the case of an incapacitated subject: who should receive a copy of the signed and dated ICF?
The subjects legally acceptable representative
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?
Consenting in the presence of figure of authority
The clinical trial phase that focuses on safety and human pharmacology in healthy volunteers
Phase I
Who is ultimately responsible for all aspects of the research conducted at a site?
Principal investigator
An international quality standard that is provided by ICH E6(R2) describing safety: accuracy of trials
and credibility of data
GCP
What event resulted in the Nuremburg Cod of 1949
Nazi Medical Experiments
Prior to archiving a study: documentation of IP destruction at the site should be filed in the study
files of the
PI and Sponsor
In the case of an incapacitated subject: who should receive a copy of the signed and dated ICF?
The subject's legally acceptable representative
Which of the following required elements should be included in a clinical trial protocol?
The subject inclusion and exclusion criteria
During a multi-site clinical study: whose responsibility is it to report subject recruitment rate?
The CRA
A study which seeks to determine the ideal dose and regimen of a new IP to treat hypothyroidism is
considered to be
Phase II
What document would an investigator reference to learn more about the previous clinical and
nonclinical results of studies of the IP?
IB
