ACRP CP CERTIFICATION EXAM QUESTIONS |
TESTED AND PROVEN ANSWERS | LATEST UPDATE
2024/2025 100% (GRADE A+)
What would be the first priority for an investigator when a subject wishes to withdraw
prematurely from the trial?
Ans>> 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
Ans>> Validation
Accuracy
Reliability
Completeness
Part of a sponsor's responsibility pertaining to electronic trial data handling is to
Ans>> maintain an audit trail, data trail, and edit trail.
A research subject's responsibilities for study participation should be described in the
1
,Ans>> ICF
What document would an investigator reference to learn more about the previous clinical
and nonclinical results of studies of the IP?
Ans>> Investigators brochure
During a multi site clinical study: whose responsibility is it to report subject recruitment
rate?
Ans>> 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
Ans>> 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...
2
,Ans>> 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?
Ans>> 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?
Ans>> 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?
Ans>> Confirm dates of initial receipt of the sponsor protocol and the IRB submission
dates.
3
, 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?
Ans>> PI
Which of the following required elements should be included in a clinical trial protocol?
Ans>> 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
Ans>> 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?
Ans>> Electronic medical record
When considering participation in a study: the investigator should determine if he...
Ans>> Sees enough patients who would qualify for the study
4
TESTED AND PROVEN ANSWERS | LATEST UPDATE
2024/2025 100% (GRADE A+)
What would be the first priority for an investigator when a subject wishes to withdraw
prematurely from the trial?
Ans>> 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
Ans>> Validation
Accuracy
Reliability
Completeness
Part of a sponsor's responsibility pertaining to electronic trial data handling is to
Ans>> maintain an audit trail, data trail, and edit trail.
A research subject's responsibilities for study participation should be described in the
1
,Ans>> ICF
What document would an investigator reference to learn more about the previous clinical
and nonclinical results of studies of the IP?
Ans>> Investigators brochure
During a multi site clinical study: whose responsibility is it to report subject recruitment
rate?
Ans>> 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
Ans>> 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...
2
,Ans>> 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?
Ans>> 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?
Ans>> 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?
Ans>> Confirm dates of initial receipt of the sponsor protocol and the IRB submission
dates.
3
, 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?
Ans>> PI
Which of the following required elements should be included in a clinical trial protocol?
Ans>> 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
Ans>> 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?
Ans>> Electronic medical record
When considering participation in a study: the investigator should determine if he...
Ans>> Sees enough patients who would qualify for the study
4
