CITI - GCP for Clinical Trials with Investigational Drugs and Biologics (ICH Focus) Questions and Answers | Latest Version | Graded A+

CITI - GCP for Clinical Trials with Investigational Drugs and Biologics (ICH Focus) Questions and Answers | Latest Version | Graded A+ What are the three core principles of ethical conduct in research involving human subjects, as outlined in the Belmont Report? a. Autonomy, Beneficence, and Confidentiality b. Respect for Persons, Beneficence, Justice c. Informed Consent, Risk Assessment, Anonymity d. Ethical Review, Institutional Approval, Participant Protection Correct answer: b. Respect for Persons, Beneficence, Justice How does the Principle of Beneficence apply to a study involving human subjects? a. By prioritizing the interests of the researchers b. By minimizing the number of participants c. By determining that the study has maximized benefits and minimized risks d. By ignoring potential risks and focusing on potential benefits Correct answer: c. By determining that the study has maximized benefits and minimized risks What are the essential components of informed consent, as described in the Belmont Report? a. Information, comprehension, coercion b. Information, comprehension, voluntariness c. Information, comprehension, legal authorization d. Information, comprehension, deception Correct answer: b. Information, comprehension, voluntariness Investigational product dispensing or administration information for the sponsor is recorded on the: Case report form The packaging of investigational drugs should ideally be designed to help with subject compliance Where is information on storage requirements for the investigational product usually found? In the study protocol Module 6 . A 46-year-old man is currently enrolled in a phase III study of a drug for severe diabetic neuropathy. While the study is ongoing, a new drug becomes commercially available that may have equal or greater benefit to the subject. The investigator should do which of the following? Discuss the pros and cons of both the investigational drug and the commercially available drug and then allow the subject to decide whether to withdraw from the research to take the new drug Which of the following statements in a consent form is an example of language that appears to waive a subject's rights? I waive any possibility of compensation for injuries that I may receive as a result of participation in this research. An investigator is confronted with a life-threatening situation that necessitates using a test article in a human subject who is unable to provide informed consent and there is no time to obtain consent from the individual's legal representative. Under the FDA regulations, which of the following describes the