ACRP-CP Certification Exam
What would be the first priority for an investigator when a Try to obtain the subject's reason for withdrawal.
subject wishes to withdraw prematurely from the trial?
CRO recently switched from paper CRF to an EDC Validation
system. The EDC system must conform to the established Accuracy
requirements for Reliability
Completeness
Part of a sponsor's responsibility pertaining to electronic maintain an audit trail, data trail, and edit trail.
trial data handling is to
A research subject's responsibilities for study participation ICF
should be described in the
What document would an investigator reference to learn Investigators brochure
more about the previous clinical and nonclinical results of
studies of the IP?
During a multi site clinical study: whose responsibility is it The CRA
to report subject recruitment rate?
An unconscious adult subject was enrolled in a study after Obtain consent from the subject for the study
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
A site is in the start up phase of an industry sponsored A signed clinical trial agreement between the site and sponsor is in place.
phase 3 trial: and has received IRB approval. The site can
begin enrolling subjects after...
A site is screening potential subjects for a study looking at A research assistant who is certified to administer the psychometric test
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 study: in which there is no intended clinical Wording indicating that there is no expected benefit should be included
benefit to the subject: is being submitted to the IRB. What
benefit information should be included in the ICF?
A CRA notices during an onsite visit that the date on IRB Confirm dates of initial receipt of the sponsor protocol and the IRB submission
approval letter for a protocol is prior to the effective date dates.
indicated on the cover page of the protocol and the
signatures of the investigator and sponsor. What should
the CRA do FIRST?
In a multi arm: randomized clinical trial: one arm of the PI
protocol was terminated due to an increased risk of cancer
in subjects. Who is responsible for providing a written
report to the IRB?
Which of the following required elements should be Subject inclusion and exclusion criteria
included in a clinical trial protocol?
Stuvia 2026-2027
, ACRP-CP Certification Exam
Prior to archiving a study: documentation of IP destruction PI and Sponsor
at the site should be filed in the study files of the
During a monitoring visit: what records would a CRA Electronic medical record
reference to verify a subject's compliance to the study visit
schedule and assessments?
When considering participation in a study: the investigator Sees enough patients who would qualify for the study
should determine if he...
New safety information has become available from the Submit a revised ICF to the IRB noting the new safety information
Sponsor about the IP being used in a clinical trial. The
investigator must
Per ICH: an IRB must keep correspondence for at least 3 Years
how long after the completion of a clinical trial?
When would an impartial witness be needed during the To observe the consent process
consent process for an illiterate subject?
A study which seeks to determine the ideal dose and Phase II
regimen of a new IP to treat hypothyroidism is considered
to be
After completion of a study: the final trial close out The sponsors files
monitoring report prepared by the CRA should be filed in
which of the following stakeholder files?
A blood sample collection is required to screen for ICF
bloodborne pathogens before subject could be enrolled in
a study. Where will subjects find information of the
procedures and any foreseeable risks or inconveniences?
When should a research study involving human subjects Before recruiting the first subject
be registered in a publicly accessible database?
In the case of an incapacitated subject: who should The subjects legally acceptable representative
receive a copy of the signed and dated ICF?
A medical student is approaches by a faculty member for Consenting in the presence of figure of authority
possible participation in a cricothyroidotomy simulation
research study. Which of the following increases risk to the
study?
The clinical trial phase that focuses on safety and human Phase I
pharmacology in healthy volunteers
Who is ultimately responsible for all aspects of the Principal investigator
research conducted at a site?
An international quality standard that is provided by ICH GCP
E6(R2) describing safety: accuracy of trials and credibility
of data
Stuvia 2026-2027
, ACRP-CP Certification Exam
What event resulted in the Nuremburg Cod of 1949 Nazi Medical Experiments
Prior to archiving a study: documentation of IP destruction PI and Sponsor
at the site should be filed in the study files of the
In the case of an incapacitated subject: who should The subject's legally acceptable representative
receive a copy of the signed and dated ICF?
Which of the following required elements should be The subject inclusion and exclusion criteria
included in a clinical trial protocol?
During a multi-site clinical study: whose responsibility is it The CRA
to report subject recruitment rate?
A study which seeks to determine the ideal dose and Phase II
regimen of a new IP to treat hypothyroidism is considered
to be
What document would an investigator reference to learn IB
more about the previous clinical and nonclinical results of
studies of the IP?
When considering participation in a study: the investigator sees enough patients who would qualify for the study
should determine if he/she
When would an impartial witness be needed during the To observe the consent process
consent process for an illiterate subject?
During a monitoring visit: what records would a CRA electronic medical record
reference to verify a subject's compliance to the study visit
schedule and assessments?
A site is screening potential subjects for a study looking at A research assistant who is certified to administer the psychometric test
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 study: in which there is no intended clinical Wording indicating that there is no expected benefit should be included.
benefit to the subject: is being submitted to the IRB/IEC.
What benefit information should be included in the ICF?
A research subject's responsibilities for study participation ICF
should be described in the
New safety information has become available from the submit a revised ICF to the IRB/IEC noting the new safety information.
Sponsor about the IP being used in a clinical trial. The
Investigator must
Stuvia 2026-2027
What would be the first priority for an investigator when a Try to obtain the subject's reason for withdrawal.
subject wishes to withdraw prematurely from the trial?
CRO recently switched from paper CRF to an EDC Validation
system. The EDC system must conform to the established Accuracy
requirements for Reliability
Completeness
Part of a sponsor's responsibility pertaining to electronic maintain an audit trail, data trail, and edit trail.
trial data handling is to
A research subject's responsibilities for study participation ICF
should be described in the
What document would an investigator reference to learn Investigators brochure
more about the previous clinical and nonclinical results of
studies of the IP?
During a multi site clinical study: whose responsibility is it The CRA
to report subject recruitment rate?
An unconscious adult subject was enrolled in a study after Obtain consent from the subject for the study
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
A site is in the start up phase of an industry sponsored A signed clinical trial agreement between the site and sponsor is in place.
phase 3 trial: and has received IRB approval. The site can
begin enrolling subjects after...
A site is screening potential subjects for a study looking at A research assistant who is certified to administer the psychometric test
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 study: in which there is no intended clinical Wording indicating that there is no expected benefit should be included
benefit to the subject: is being submitted to the IRB. What
benefit information should be included in the ICF?
A CRA notices during an onsite visit that the date on IRB Confirm dates of initial receipt of the sponsor protocol and the IRB submission
approval letter for a protocol is prior to the effective date dates.
indicated on the cover page of the protocol and the
signatures of the investigator and sponsor. What should
the CRA do FIRST?
In a multi arm: randomized clinical trial: one arm of the PI
protocol was terminated due to an increased risk of cancer
in subjects. Who is responsible for providing a written
report to the IRB?
Which of the following required elements should be Subject inclusion and exclusion criteria
included in a clinical trial protocol?
Stuvia 2026-2027
, ACRP-CP Certification Exam
Prior to archiving a study: documentation of IP destruction PI and Sponsor
at the site should be filed in the study files of the
During a monitoring visit: what records would a CRA Electronic medical record
reference to verify a subject's compliance to the study visit
schedule and assessments?
When considering participation in a study: the investigator Sees enough patients who would qualify for the study
should determine if he...
New safety information has become available from the Submit a revised ICF to the IRB noting the new safety information
Sponsor about the IP being used in a clinical trial. The
investigator must
Per ICH: an IRB must keep correspondence for at least 3 Years
how long after the completion of a clinical trial?
When would an impartial witness be needed during the To observe the consent process
consent process for an illiterate subject?
A study which seeks to determine the ideal dose and Phase II
regimen of a new IP to treat hypothyroidism is considered
to be
After completion of a study: the final trial close out The sponsors files
monitoring report prepared by the CRA should be filed in
which of the following stakeholder files?
A blood sample collection is required to screen for ICF
bloodborne pathogens before subject could be enrolled in
a study. Where will subjects find information of the
procedures and any foreseeable risks or inconveniences?
When should a research study involving human subjects Before recruiting the first subject
be registered in a publicly accessible database?
In the case of an incapacitated subject: who should The subjects legally acceptable representative
receive a copy of the signed and dated ICF?
A medical student is approaches by a faculty member for Consenting in the presence of figure of authority
possible participation in a cricothyroidotomy simulation
research study. Which of the following increases risk to the
study?
The clinical trial phase that focuses on safety and human Phase I
pharmacology in healthy volunteers
Who is ultimately responsible for all aspects of the Principal investigator
research conducted at a site?
An international quality standard that is provided by ICH GCP
E6(R2) describing safety: accuracy of trials and credibility
of data
Stuvia 2026-2027
, ACRP-CP Certification Exam
What event resulted in the Nuremburg Cod of 1949 Nazi Medical Experiments
Prior to archiving a study: documentation of IP destruction PI and Sponsor
at the site should be filed in the study files of the
In the case of an incapacitated subject: who should The subject's legally acceptable representative
receive a copy of the signed and dated ICF?
Which of the following required elements should be The subject inclusion and exclusion criteria
included in a clinical trial protocol?
During a multi-site clinical study: whose responsibility is it The CRA
to report subject recruitment rate?
A study which seeks to determine the ideal dose and Phase II
regimen of a new IP to treat hypothyroidism is considered
to be
What document would an investigator reference to learn IB
more about the previous clinical and nonclinical results of
studies of the IP?
When considering participation in a study: the investigator sees enough patients who would qualify for the study
should determine if he/she
When would an impartial witness be needed during the To observe the consent process
consent process for an illiterate subject?
During a monitoring visit: what records would a CRA electronic medical record
reference to verify a subject's compliance to the study visit
schedule and assessments?
A site is screening potential subjects for a study looking at A research assistant who is certified to administer the psychometric test
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 study: in which there is no intended clinical Wording indicating that there is no expected benefit should be included.
benefit to the subject: is being submitted to the IRB/IEC.
What benefit information should be included in the ICF?
A research subject's responsibilities for study participation ICF
should be described in the
New safety information has become available from the submit a revised ICF to the IRB/IEC noting the new safety information.
Sponsor about the IP being used in a clinical trial. The
Investigator must
Stuvia 2026-2027
