Good Clinical Practice Course (Medical Clinical Research) Questions and Answers | Latest Version | 2024/2025 | Already Passed

Good Clinical Practice Course (Medical Clinical Research) Questions and Answers | Latest Version | 2024/2025 | Already Passed What is the primary objective of the International Council for Harmonization (ICH)? a. To ensure global consistency in clinical trials b. To reduce duplication of clinical trials and improve efficiency c. To promote new drug development worldwide d. To establish a single regulatory framework for all countries The ICH Good Clinical Practice (GCP) guidelines aim to: a. Regulate clinical research sites and investigators b. Establish standards for designing, conducting, monitoring, and reporting clinical research c. Ensure global marketing approval for clinical trials d. Simplify the regulatory process for international drug studies ICH E6 outlines standards applicable to which stakeholders? a. Clinical research coordinators only b. Investigators, sponsors, and Institutional Review Boards (IRBs) c. Sponsors only d. IRBs only In the United States, adhering to ICH E6 guidelines is: a. Mandatory for all clinical trials b. Voluntary for investigational device studies c. Voluntary for FDA-regulated drug studies d. Mandatory for studies conducted outside the United States Which of the following are the three principles included in the Belmont Report? a. IRB review, Federal regulations, Declaration of Helsinki. b. Informed Consent, Institutional Assurance, Researcher responsibility. c. Privacy, Confidentiality, Equitable selection of subjects. d. Respect for Persons, Beneficence, Justice. d. Respect for Persons, Beneficence, Justice. Which of the following is an example of how the Principle of Beneficence can be applied to a study employing human subjects? a. Ensuring that confidentiality is maintained. b. Determining that the study has maximized benefits and minimized risks. c. Insuring that the selection of subjects includes people from all segments of the population. d. Providing detailed information about the study and obtaining the subject's consent to participate. b. Determining that the study has maximized benefits and minimized risks. Which of the following best describes the principle of Respect for Persons as described in the Belmont Report?