ACRP CP Practice Questions and Answers () With Complete Solution

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 sho