ICH E6 Good Clinical Practice correctly answered graded A+ 2023/2024

ICH E6 Good Clinical Practice Adverse Drug Reaction (ADR) - correct answer The phrase responses to a medicinal product means that a causal relationship between a medicinal product and an adverse event is at least a reasonable possibility, i.e., the relationship cannot be ruled out. Adverse Event (AE) - correct answer Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. Declaration of Helsinki - correct answer Clinical trials should be conducted in accordance with the ethical principles that have their origin in the ______________________, and that are consistent with GCP and the applicable regulatory requirement(s). Benefits - correct answer Before a trial is initiated, foreseeable risks and inconveniences should be weighed against the anticipated benefit for the individual trial subject and society. A trial should be initiated and continued only if the anticipated ___________ justify the risks. Subjects - correct answer The rights, safety, and well-being of the trial _____________ are the most important considerations and should prevail over interests of science and society. Investigational Product - correct answer The available nonclinical and clinical information on an ___________________ should be adequate to support the proposed clinical trial. Protocol - correct answer Clinical trials should be scientifically sound, and described in a clear, detailed ______________. Once - correct answer The IRB/IEC should conduct continuing review of each ongoing trial at intervals appropriate to the degree of risk to human subjects, but at least _______ per year.