Good Clinical Practice Questions Latest Update | 2024/2025 | Already Passed

Good Clinical Practice Questions Latest Update | 2024/2025 | Already Passed What are the three fundamental principles outlined in the Belmont Report? • Autonomy • Compassion • Fairness How can the Principle of Compassion be applied to a research study involving human subjects? • By ensuring that the study maximizes potential benefits and minimizes potential risks to participants. The Belmont Report's principle of compassion includes two core guidelines: (1) do no harm and (2) maximize potential benefits while minimizing potential harms. Providing participants with detailed information about the study and obtaining their informed consent to participate is an example of respecting autonomy. Ensuring a diverse representation of participants from all segments of society is an example of fairness. Maintaining confidentiality is a regulatory requirement, but it can also be seen as an extension of autonomy and compassion. What best describes the principle of Autonomy as outlined in the Belmont Report? • Understanding • Voluntary Participation The principle of autonomy requires that participants have the opportunity to make their own decisions about what happens to them, to the extent that they are capable. This is achieved through adequate informed consent, which consists of three essential elements: understanding, comprehension, and voluntariness. When explaining the probability of assignment to trial arms in consent forms, what is true? • The International Council on Harmonization (ICH) recommends including this information, but does not specify how it should be presented. The ICH guidelines state that informed consent discussions and written forms should include the probability of random assignment to each treatment arm, but do not specify how this information should be presented. The FDA requires identification of experimental procedures but does not specify inclusion of probability for random assignment to each treatment. The new ICH E6(R2) integrated addendum requires sponsors to implement systems to manage quality throughout all stages of the trial process. The system should use a risk-based approach including which of the following? • Identification of study risks to determine which may safely be omitted from continual monitoring. * ICH (2016) E6 Section 5.0.4 states that the sponsor should decide which risks to reduce and/or which risks to accept. The approach used to reduce risk to an acceptable level should be proportionate to the significance of the risk. Risk reduction activities may be incorporated in protocol design and implementation, monitoring plans, and agreements. Routine scheduled audits of study documentation whether on-site or remote are not considered fully responsive to the need for continuous monitoring of data under a proactive risk-based approach. While data from Case Report Forms may be selected for ongoing monitoring, there is no ICH template and a "one-size-fits-all" approach is not appropriate for study-specific monitoring. The use of any specific method of analysis quality improvement is not required and routine annual review may not be sufficient for monitoring the study-specific risks