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