ACRP CP CERTIFICATION EXAM 2024 ACTUAL EXAM COMPLETE ACCURATE EXAM QUESTIONS WITH DETAILED VERIFIED ANSWERS (100% CORRECT ANSWERS

ACRP CP CERTIFICATION EXAM 2024 ACTUAL EXAM COMPLETE ACCURATE EXAM QUESTIONS WITH DETAILED VERIFIED ANSWERS (100% CORRECT ANSWERS 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. 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? - Correct 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? - Correct Answer Wording indicating that there is no expected benefit should be included A CRA notices during an onsite visit that the date on IRB approval letter for a protocol is prior to the effective date indicated on the cover page of the protocol and the signatures of the investigator and sponsor. What should the CRA do FIRST? - Correct Answer Confirm dates of initial receipt of the sponsor protocol and the IRB submission dates. In a multi arm: randomized clinical trial: one arm of the protocol was terminated due to an increased risk of cancer in subjects. Who is responsible for providing a written report to the IRB? - Correct Answer PI Which of the following required elements