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ACRP CP PRACTICE QUESTIONS WITH ANSWERS 2023 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 - A...

A subject is issued 120 tablets and is instructed to take 2 tablets 4 times a day. He returns 88 tablets on the morning of day 9 fasting for laboratory tests. What percent compliant is he? - Answer 50% To be eligible for a trial, the subjects must have liver function tests no greater than two times the upper limit normal and rental function tests no greater than three times the upper limit normal. All of the following are normal ranges for the trial: AST 5-65 ALT 5-35 BUN 4-25 Crea...

Adverse Drug Reaction (ADR) - Answer All noxious and unintended responses to a medicinal product related to any dose (causal relationship is at least a reasonable possibility). Regarding marketed medicinal products: a response to a drug which is noxious and unintended and which occurs at doses normally used in man for prophylaxis, diagnosis, or therapy of diseases or for modification of physiological function Adverse Event (AE) - Answer Any untoward medical occurrence in a patient or ...

ATI COMPREHENSIVE EXIT EXAM RETAKE 2023/2024| 180 VERIFIED QUESTIONS AND ANSWER