2024 ACRP CP FINAL EXAM LATEST REAL
EXAM 150 QUESTIONS AND CORRECT
ANSWERS|AGRADE
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
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.
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 informatiom
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
EXAM 150 QUESTIONS AND CORRECT
ANSWERS|AGRADE
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
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.
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 informatiom
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
