ACRP Exam Questions With Latest Solutions 2024

ACRP Exam Questions With Latest Solutions 2024 1. What is the purpose of ICH-GCP? a. To standardize the design, conduct, recording, and reporting of clinical trials b. To instruct clinicians as to how to conduct preclinical toxicology tests c. To ensure that subjects are treated with the best available therapy d. To increase the number of abbreviations used in clinical practice - answera 2. What is the purpose of the IRB/IEC? a. To help ensure that trials are conducted according to the protocol b. To monitor clinical trials c. To design trial protocols d. To protect subject safety - answerd 3. According to ICH, the abbreviation 'LAR' stands for 'Legally authorized Representative'. a. True b. False - answerb What is the minimum number of members on an IRB/IEC? a. 3 b. 5 c. 7 d. 8 - answerb 5. Who is responsible for providing the trial protocol? a. The sponsor b. The investigator c. The IRB/IEC d. The Institution - answera What does 'DSMB' stand for? a. Data Record Monitoring Board b. Drug Statistics Measurement Bureau c. Drug Safety Monitoring Board d. Data and Safety Monitoring Board - answerd 7. In any trial, what should be the main concern of the physician? a. The welfare of the subjects b. Ensuring that the allotted quota of subjects enrolled c. The esteem that will be gained from a successful trial outcome d. The scientific outcome of the trial - answera 8. The World Medical Association (WMA) ethical principles for medical research involving human subjects is called: a. The International Research Act b. The Belmont Report c. The National Research Act d. The Declaration of Helsinki - answerd 9. The process by which a subject voluntarily confirms his or her willingness to participate in a clinical trial is known as: a. Intent to treat b. Legally authorized agreement c. Informed consent of trial subjects d. IRB/IEC approval - answerc 10. One of the primary purposes of a Phase I study is to: a. Demonstrate long term safety and efficacy b. Determine he metabolic and pharmacologic action of the drug in humans c. Demonstrate efficacy within the established safe dose range d. Gather information on additional indications for the drug - answerb 11. What is the purpose of the 'Data and Safety Monitoring Board (DSMB)'? a. To approve the trial protocol b. To ensure that the monitor is performing his/her duties correctly c. To assess the progress of a clinical trial, the safety data, and the critical efficacy endpoints d. To ensure the accuracy of data and to carry out data analysis - answerc 12. What does the IRB/IEC evaluate? (select all that apply) a. The subject-selection procedure b. The rights, safety, and well-being of the subjects participating in the trial c. The scientific tenability of the trial d. The contract between the sponsor and investigator - answera, b, c 13. Which of the following documents is the investigator obliged to comply with during the trial? (select all that apply) a. The sponsor's desire to present the investigational product in the best possible light b. All applicable laws and regulations c. ICH-GCP d. The trial protocol - answerb, c, d 14. What is the purpose of the initiation visit? (Select all that apply) a. To carry out source documentation verification b. To review standard procedures c. To review the blank Case Report Forms (CRFs)