ACRP CP FINAL EXAM

ACRP CP FINAL EXAM LATEST 2023 REAL EXAM 150 QUESTIONS AND CORRECT ANSWERS|AGRADE What document would an investigator reference to learn more about the previous clinical and nonclinical results of studies of the IP? - answer IB When considering participation in a study, the investigator should determine if he/she: -answer sees enough patients who would qualify for the study. When would an impartial witness be needed during the consent process for an illiterate subject? - answer To observe the consent process During a monitoring visit, what records would a CRA reference to verify a subject's compliance to the study visit schedule and assessments? - answer Electronic medical record A site is screening potential 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? - 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/IEC. What benefit information should be included in the ICF? - answer Wording indicating that there is no expected benefit should be included. A research subject's responsibilities for study participation should be described in the: - answer ICF New safety information has become available from the Sponsor about the IP being used in a clinical trial. The Investigator must: - answer submit a revised ICF to the IRB/IEC noting the new safety information. A medical student is approached by a faculty member for possible participation in a cricothyroidotomy simulation research study. Which of the following increases risk to the subject? - answer Consenting in the presence of figure of authority 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. 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 foreseeable risks or inconveniences? - answer ICF Per ICH, an IRB/IEC must keep correspondence for at least how long after the completion of a clinical trial? - answer 3 years A CRA notices during an onsite visit that the date on IRB/IEC approval letter for a protocol is prior to the effective date indicated on the cover page of the protocol and the signatures of the investigator and sponsor. What should the CRA do FIRST? - answer Confirm dates of initial receipt of the sponsor protocol and the IRB/IEC submission dates. A CRO recently switched from paper CRF to an EDC system. The EDC system must conform to the established requirements for: - answer validation, accuracy, reliability, and completeness. When should a research study involving human subjects be registered in a publicly accessible database? - answer Before recruiting the first subject 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. After completion of a study, the final trial close-out monitoring report prepared by the CRA should be filed in which of the following stakeholder files? - answer The sponsor's files A site is in the start-up phase of an industry-sponsored phase 3 trial, and has received IRB/IEC approval. The site can begin enrolling subjects after: - answer a signed clinical trial agreement between the site and sponsor is in place. In a multi-arm, randomized clinical trial, one arm of the protocol was terminated due to an increased risk of breast cancer in the subjects. Who is responsible for providing a written report to the IRB/IEC? - answer PI Part of a sponsor's responsibility pertaining to electronic trial data handling is to - answer maintain an audit trail, data trail, and edit trail. Which entity is primarily charged with considering subject rights and well-being during clinical trials? - answer Institutional Review Board (IRB)/Independent Ethics Committee (IEC) Which of the following would be considered a vulnerable population requiring special consideration by an IRB/IEC? - answer 1. Medical, pharmacy, dental, and nursing students 2. Prisoners 4. Serving military personnel T or F: The terms "serious" and "severe" are synonymous according to ICH -answer False An Unexpected Adverse drug reaction is: - answer A reaction that is not consistent with the applicable product information ICH safety definitions can be found in - answer ICH E2A An Adverse Event (AE) that is severe in intensity - answer May not meet the definition of serious T or F: Information discovered during the course of a clinical investigation that might materially influence the benefit-risk assessment of the investigation/product may necessitate rapid communication to regulatory authorities. - answer True Subject 3826 had to stay in the hospital for three extra days when his legs started swelling after participation in a cardiac drug study. Swelling of the legs was listed in the Investigator's Brochure as a possible side effect. This is considered a/an: - answer Serious Adverse Drug Reaction T or F: A subject in your diabetes research study developed colon cancer, which the Investigator has determined to be unrelated to the study. The subject is currently asymptomatic. This will be considered a serious adverse event because it is life threatening. - answer False In pre-market approval studies, all noxious and unintended responses to a medicinal product even possibly related to any dose should be considered: - answer Adverse Drug Reaction You were just informed that you have a research patient that is receiving intensive treatment in an emergency room for allergic bronchospasm. This should be considered as: - answer A serious adverse event After a Serious Adverse Event (SAE) has occurred, how should you list the subject identification on the immediate and follow-up reports? - answer By their subject identification number In which scenario would unblinding typically occur? - answer When the investigator wants to make sure a particular subject is not randomized to placebo in the case of a Serious Adverse Event (SAE)