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; Create 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 This study source was downloaded by 100000835004878 from CourseHero.com on 01-08-2023 09:11:54 GMT -06:00 https://www.coursehero.com/file/169693475/ACRP-Practice-Exam-2022-Questions-and-Answersdocx/ home with him. According to ICH Guidelines, which are the best actions for the CRC to take initially? - ANSWER Have the subject sign the ICF Confirm the subject's understanding of the ICF A CRC is enrolling three subjects for a Phase III trial with restrictive eligibility criteria. The PI indicates that she must leave the office to teach a lecture in 30 minutes. The lab will be closing in 1 hour. Which of the following is the MOST appropriate action for the CRC? - ANSWER Give each subject sufficient time to review the ICF All of the following are regulatory documents except: informed consent protocol signature page lab certification confidentiality agreement - ANSWER confidentiality agreement If the patient's weight is 123 lb, what is the weight in kg? - ANSWER 56 A CRA calls to schedule a close-out visit. Per sponsor SOPs, the PI must be present. The CRC informs the CRA That the PI will be out of the country during the period when the CRA would like to visit. The CRC should do which of the following? - ANSWER Reschedule the close-out visit for a later date The CRC reviewed a new protocol to prepare the trial budget for submission to the sponsor. According to the protocol, each subject is to return for follow up visits at 30 days, 60 months and 1 year. At 30 days, protocol requires a physical exam, an ECG and chest xray At 6 months, physical and ECG At 1 year, physical, ECG and chest xray The hospital charges $75 for the physical exam, $50 for the ECG and $100 for chest xray. The 30day and 1year visits are SOC for the subjects. How much should the CRC budget for the non-SOC visits? - ANSWER $125 According to ICH guidelines, the source document should contain which of the following information regarding informed consent? - ANSWER Evidence that the consent form was signed prior to trial related procedures A subject has signed the informed consent form for a hypertenstion trial. All screening procedures and the physical examination have been completed. The CRC is ready to dispense the single-blind placebo to the subject who asks "Is that the sugar pill I read about in that form I signed?" Which of the following should the CRC tell the subject? - ANSWER "It might be placebo, but we will be checking your blood pressure every week" At the month 3 visit of a Phase III double-blind trial, the subject informs the CRC that he was seen in the emergency department for an anaphylactic reaction. The subject states "The doctor told me i was very lucky. I might have died". Having received this This study source was downloaded by 100000835004878 from CourseHero.com on 01-08-2023 09:11:54 GMT -06:00 https://www.coursehero.com/file/169693475/ACRP-Practice-Exam-2022-Questions-and-Answersdocx/ information, the MOST appropriate sequence of action is to inform the: - ANSWER PI, sponsor and IRB