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2024 ACRP CP FINAL EXAM LATEST REAL EXAM 150 QUESTIONS AND CORRECT ANSWERS|AGRADE
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2024 ACRP CP FINAL EXAM LATEST REAL EXAM 150 QUESTIONS AND CORRECT ANSWERS|AGRADE
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2024 ACRP CP FINAL EXAM LATEST REAL EXAM 150 QUESTIONS AND CORRECT ANSWERS|AGRADE A research subj ect'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 ✔✔ Invest igators brochure 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 re quirements 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. 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 w as 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 potentia l 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 bene fit informatiom 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 dat e 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 s hould be included in a clinical trial protocol? - CORRECT ANSWER ✔✔ Subject inclusion and exclusion criteria Prior to archiving a study, documentation of IP destruction at the site should be filed in the study files of the - CORRECT ANSWER ✔✔ PI and Sponsor During a monitoring visit, what records would a CRA reference to verify a subject's compliance to the study visit schedule and assessments? - CORRECT ANSWER ✔✔ Electronic medical record When considering participation in a study, the investigator should dete rmine if he... - CORRECT ANSWER ✔✔ Sees enough patients who would qualify for the study New safety information has become available from the Sponsor about the IP being used in a clinical trial. The investigator must: - CORRECT ANSWER✔✔ Submit a revised ICF t o the IRB noting the new safety information Per ICH, an IRB must keep correspondence for at least how long after the completion of a clinical trial? - CORRECT ANSWER ✔✔ 3 Years When would an impartial witness be needed during the consent process for an ill iterate subject? - CORRECT ANSWER ✔✔ To observe the consent process A study which seeks to determine the ideal dose and regimen of a new IP to treat hypothyroidism is considered to be: - CORRECT ANSWER ✔✔
Phase II
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