ACRP CP PRACTICE QUESTIONS WITH
ANSWERS 2024
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
ANSWERS 2024
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
