Good Clinical Practice Questions and Answers | Latest Version | 2024/2025 | Already Passed

Good Clinical Practice Questions and Answers | Latest Version | 2024/2025 | Already Passed What is the principle of Respect for Persons, as described in the Belmont Report, primarily focused on? a) Ensuring that research is conducted ethically b) Protecting the dignity and autonomy of individuals c) Guaranteeing that research participants receive a fair share of benefits d) Maximizing the potential risks and benefits of research Correct answer: b) Protecting the dignity and autonomy of individuals What is bioavailability, in the context of pharmacology? a) The rate at which a medication is eliminated from the body b) The rate at which a medication becomes available at the targeted place in the body c) The maximum amount of a medication that can be absorbed d) The minimum amount of a medication that can be absorbed Correct answer: b) The rate at which a medication becomes available at the targeted place in the body What type of clinical trial involves comparing the effects of an experimental agent to those of a standard treatment, where subjects are randomly assigned to one of these two groups? a) Open-label trial b) Double-blind trial c) Controlled trial d) Single-arm trial Correct answer: c) Controlled trial What is Good Clinical Practice (GCP), in the context of clinical trials? a) A set of guidelines for designing clinical trials b) A framework for conducting clinical trials c) A standard for the design, conduct, performance, monitoring, auditing, recording, analyses, and reporting of clinical trials d) A regulation for managing clinical trial data Correct answer: c) A standard for the design, conduct, performance, monitoring, auditing, recording, analyses, and reporting of clinical trials _________________ is a compilation of the pre-clinical and clinical data on the investigational product(s) that are relevant to the study of the product(s) in human subjects. The Investigator's Brochure (IB) ICH E6 also defines what a "____________________" of the original record is. In order for a record to be (this), the paper or electronic copy of the original record must have been verified (for example, by a dated signature) or generated through a validated process to produce an exact copy of the original. Certified Copy The first Investigator's Brochure IB for a proposed clinical trial of a new drug is based primarily on which of the following?