ACRP CP FINAL / ACRP CP ACTUAL FINAL EXAM
2024/2025 COMPLETE EXAM WITH REAL QUESTIONS
AND CORRECT VERIFIED ANSWERS LATEST UPDATE
GUARANTEED PASS A+ (REVISED EXAM)
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.
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
Part of a sponsor's responsibility pertaining to electronic
trial data handling is to - ANSWER ->maintain an audit
trail, data trail, and edit trail.
A research subject's responsibilities for study
participation should be described in the - ANSWER ->ICF
,What document would an investigator reference to learn
more about the previous clinical and nonclinical results
of studies of the IP? - ANSWER ->Investigators brochure
During a multi site clinical study: whose responsibility is it
to report subject recruitment rate? - 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 - 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... - 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? - 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? -
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? - 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? - ANSWER ->PI
Which of the following required elements should be
included in a clinical trial protocol? - 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 - 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? - ANSWER ->Electronic
medical record
When considering participation in a study: the
investigator should determine if he... - 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 - 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? -
ANSWER ->3 Years
When would an impartial witness be needed during the
consent process for an illiterate subject? - ANSWER ->To
observe the consent process
2024/2025 COMPLETE EXAM WITH REAL QUESTIONS
AND CORRECT VERIFIED ANSWERS LATEST UPDATE
GUARANTEED PASS A+ (REVISED EXAM)
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.
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
Part of a sponsor's responsibility pertaining to electronic
trial data handling is to - ANSWER ->maintain an audit
trail, data trail, and edit trail.
A research subject's responsibilities for study
participation should be described in the - ANSWER ->ICF
,What document would an investigator reference to learn
more about the previous clinical and nonclinical results
of studies of the IP? - ANSWER ->Investigators brochure
During a multi site clinical study: whose responsibility is it
to report subject recruitment rate? - 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 - 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... - 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? - 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? -
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? - 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? - ANSWER ->PI
Which of the following required elements should be
included in a clinical trial protocol? - 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 - 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? - ANSWER ->Electronic
medical record
When considering participation in a study: the
investigator should determine if he... - 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 - 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? -
ANSWER ->3 Years
When would an impartial witness be needed during the
consent process for an illiterate subject? - ANSWER ->To
observe the consent process
