ACRP Practice Exam Questions And Answers 2023

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 Creat 0.5-1.2 Amylase 56-190 Lipase 4-24 ALK Phos 0-110 - Answer- AST 130; ALT; 70; BUN 50; Creat 2.4 A subject presents at a site with her husband after pre-qualifying on a phone screen. She states that she is legally blind and cannot read the ICF. A Braille ICF is not available. This subject is able to sign her name if her hand is guided to the signature line. Which of the following is the BEST course of action to obtain legal consent from the subject? - Answer- The subject and an impartial witness can sign the ICF after it is read to them and she verbally states her understanding. Which of the following is MOST useful for scheduling trial procedures? - Answer- trial schedule of events A subject is participating in a clinical trial where only the pharmacist and sponsor knows the identity of the IP. The pharmacist has no contact with the trial subject and the clinical team. Which of the following BEST describes this trial type? - Answer- double blind A site has not received IRB/IEC approval for a protocol submission. The PI instructs the CRC employed by the clinic to begin scheduling subjects for screening appointments. Which of the following is the BEST course of action for the CRC to take? - Answer- Review the research database and collate a list of potential subjects The trough blood level for once daily drug should be drawn how long after the last dose? - Answer- 24 hours A potential subject for a trial has been mailed an ICF prior to his screening visit. When the subject arrives at the research dept for his screening visit, he states he read the ICF and is ready to do the trial. He does not have a copy of the ICF that was mailed to his home with him. According to ICH Guidelines, which are the best actions for the CRC to take initially?