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ACRP CP PRACTICE EXAM QUESTIONS AND ANSWERS
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ACRP CP PRACTICE EXAM QUESTIONS AND ANSWERS
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ACRP CP PRACTICE EXAM QUESTIONSAND ANSWERS
What would be the first priority for an investigator when a subject wishes to
withdraw prematurely from the trial? - -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: - -Validation, accuracy,
reliability, completeness
-Part of a sponsor's responsibility pertaining to electronic trial data handling
is to - -maintain an audit trail, data trail, and edit trail.
-A research subject's responsibilities for study participation should be
described in the: - -ICF
-What document would an investigator reference to learn more about the
previous clinical and nonclinical results of studies of the IP? - -Investigators
brochure
-During a multi site clinical study, whose responsibility is it to report subject
recruitment rate? - -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 - -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... - -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? - -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
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