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ICH GCP Test with Questions and Answers 2023
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ICH GCP Test with Questions and Answers 2023
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ICH GCP Test with Questions and Answers 2023 • 1. Neither the investigator nor the trial staff should ________ or unduly influence a subject to participate or to continue to participate in a trial. o A. Convince o B. Coerce o C. Compel o D. Change the opinion Correct Answer B. Coerce Explanation The correct answer is "Coerce". Coercion refers to the act of using force, threats, or pressure to persuade someone to do something against their will. In the context of a trial, it is important that both the investigator and trial staff do not exert any u ndue influence or manipulate the subjects into participating or continuing to participate in the trial. This ensures that the subjects' decision to participate is voluntary and not influenced by external factors. Rate this question: • 2. Who is responsible for the conduct of the clinical trial at a trial site? o A. Clinical Research Coordinator o B. Monitor o C. Investigator o D. Sponsor Correct Answer C. Investigator Explanation The investigator is responsible for the conduct of the clinical trial at a trial site. The investigator is typically a qualified healthcare professional who oversees the trial, ensures the safety and well -being of the participants, and follows the protocol and regulations set by the regulatory authorities. They are responsible for recruiting and enrolling participants, collecting and analyzing data, and reporting any adverse events or outcomes. The investigator plays a crucial role in ensuring t he integrity and success of the clinical trial. Rate this question: • 3. Which is NOT one of the purposes of trial monitoring? o A. To verity that the rights and well -being of human subjects are protected. o B. To verify that the reported trial data are accurate, complete, and verifiable from source documents. o C. To verify that all financial obligations between the Sponsor and the Investigator are fulfilled. o D. To verify that the conduct of the trial is in compliance with the currently approved protocol/amendment(s), with GCP, and with applicable regulatory requirement(s). Correct Answer C. To verify that all financial obligations between the Sponsor and the Investigator are fulfilled. Explanation Trial monitoring is a process that ensures the ethical conduct of clinical trials. It involves various purposes such as protecting the rights and well-being of human subjects, verifying the accuracy of trial data, ensuring compliance with protocols and reg ulatory requirements. However, one purpose that is NOT included in trial monitoring is verifying financial obligations between the Sponsor and the Investigator. This aspect is typically handled through financial audits or contractual agreements, rather tha n trial monitoring. Rate this question: • 4. The sponsor should ensure that it is specified in the protocol or other written agreement that the investigator(s)/institution(s) provide direct access to source data/documents for trial -related monitoring, audits, IRB/IEC review, and regulatory inspection . o A. True o B. False Correct Answer A. True Explanation The sponsor should ensure that the protocol or written agreement explicitly states that the investigator or institution will provide direct access to source data/documents for various purposes such as trial -related monitoring, audits, IRB/IEC review, and r egulatory inspection. This means that the sponsor should ensure that there is a clear provision in place for accessing the original data and documents related to the trial, which is essential for ensuring the integrity and validity of the study. Rate this question: • 5. Clinical trials should be conducted in accordance with the ethical principles that are consistent with GCP and the applicable regulatory requirement(s), and that have their origin in the Declaration of ___________. o A. Clinical Research Regulations o B. Independence o C. Geneva Conference o D. Helsinki
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