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ACRP CP FINAL EXAM LATEST 2023 REAL EXAM 150 QUESTIONS AND CORRECT ANSWERS|AGRADE
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ACRP CP FINAL EXAM LATEST 2023 REAL EXAM 150 QUESTIONS AND CORRECT ANSWERS|AGRADE
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ACRP CP FINAL EXAM LATEST 2023 REAL EXAM 150 QUESTIONS AND CORRECT ANSWERS|AGRADE What would be the first priority for an investigator wh en 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 - ANSWER - maintain an audit trail, data trail, and edit trail. A research subject's responsibilities for study participation should be described in the: - ANSWER - ICF What document would an investigator reference to learn more about the previous clinical and nonclinical results of studies of the IP? - ANSWER - Investigators brochure During a multi site clinical study, whose responsibility is it to report subject recruitment rate? - 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 - ANSWER - Obtain consent from the subject for the study A site is in the start up phase of an industry spo nsored phase 3 trial, and has received IRB approval. The site can begin enrolling subjects after... - 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 cog nitive 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? - 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 informatiom should be included in the ICF? - 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 sign atures of the investigator and sponsor. What should the CRA do FIRST? - 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? - ANSWER - PI Which of the following required elements should be included in a clinical trial protocol? - ANSWER - Subject inclusion and exclusion criter ia Prior to archiving a study, documentation of IP destruction at the site should be filed in the study files of the - ANSWER - PI and Sponsor During a monitoring visit, what records would a CRA reference to verify a subject's compliance to the study visi t schedule and assessments? - ANSWER - Electronic medical record When considering participation in a study, the investigator should determine if he... - ANSWER - Sees enough patients who would qualify for the study New safety information has become availab le from the Sponsor about the IP being used in a clinical trial. The investigator must: - ANSWER - Submit a revised ICF to the IRB noting the new safety information Per ICH, an IRB must keep correspondence for at least how long after the completion of a cl inical trial? - ANSWER - 3 Years When would an impartial witness be needed during the consent process for an illiterate subject? - 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: - ANSWER - Phase II After completion of a study, the final trial close out monitoring report prepared by the CRA should be filed in which o f the following stakeholder files? - ANSWER - The sponsors files A blood sample collection is required to screen for bloodborne pathogens before subject could be enrolled in a study. Where will subjects find information of the procedures and any foreseeabl e risks or inconveniences? - ANSWER - ICF When should a research study involving human subjects be registered in a publicly accessible database? - ANSWER - Before recruiting the first subject In the case of an incapacitated subject, who should receive a co py of the signed and dated ICF? - ANSWER - The subjects legally acceptable representative A medical student is approaches by a faculty member for possible participation in a cricothyroidotomy simulation research study. Which of the following increases risk to the study? - ANSWER - Consenting in the presence of figure of authority Phase I - ANSWER - The clinical trial phase that focuses on safety and human pharmacology in healthy volunteers Who is ultimately responsible for all aspects of the research conducted at a site? - ANSWER - Principal investigator Define GCP - ANSWER - An int ernational quality standard that is provided by ICH E6(R2) describing safety, accuracy of trials and credibility of data What event resulted in the Nuremburg Cod of 1949 - ANSWER - Nazi Medical ExperimentsThe benefits of buying summaries with Stuvia:
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