ACRP CP FINAL EXAM LATEST REAL EXAM 150 QUESTIONS AND CORRECT ANSWERS|AGRADE

ACRP CP FINAL EXAM LATEST REAL EXAM 150 QUESTIONS AND CORRECT ANSWERS|AGRADE
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