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

Good Clinical Practice Questions and Answers | Latest Update | 2024/2025 | Already Passed Which of the following describes the principle of Respect for Persons in the Belmont Report? a) Assessment of risk and benefit, justification of research, understanding b) Understanding, management of conflicts of interest, risk and benefit analysis c) Provision of information, understanding, voluntary participation d) Voluntary participation, risk and benefit assessment, selection of subjects c) Provision of information, understanding, voluntary participation ______ refers to how quickly or to what extent a medication or substance is absorbed or becomes available at its intended site in the body. Bioavailability In clinical trials, subjects are divided into groups: those receiving the experimental agent and those receiving standard treatment, no treatment, or a placebo. If subjects are randomly assigned to these groups, it is called a ______ trial. Controlled _________ sets the standards for every aspect of clinical trials, including design, execution, monitoring, auditing, data recording, analysis, and reporting. Good Clinical Practice (GCP) _________ describes the effects of a substance within the body. Pharmacodynamics _________ involves using genetic information to predict a drug's impact on a patient's health. Pharmacogenomics _________ explains how a substance moves through and is eliminated from the body. Pharmacokinetics The first step in the drug-development process allows investigators to evaluate the drug using tissue cultures and animal models. This research is referred to as ______________. preclinical studies _________________ 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