ACRP CP PRACTICE EXAM GRADED A /
QUESTIONS AND ANSWERS 2023/2024
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.
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
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
QUESTIONS AND ANSWERS 2023/2024
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.
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
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
