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

Good Clinical Practice ICH Questions and Answers | Latest Version | 2024/2025 | Already Passed What is the primary focus of Good Clinical Practice (GCP)? A) To ensure the efficacy of clinical trials B) To protect the rights and well-being of human subjects C) To streamline the regulatory approval process D) To reduce the costs of clinical research B) To protect the rights and well-being of human subjects Explanation: Good Clinical Practice (GCP) is an international standard that aims to ensure that clinical trials are conducted in a way that respects the rights, safety, and well-being of human subjects. What does Good Clinical Practice (GCP) guarantee? A) That clinical trial data will be accepted by regulatory authorities B) That clinical trials will be conducted efficiently and cost-effectively C) That clinical trial participants will receive effective treatment D) That the rights, safety, and well-being of trial subjects are protected D) That the rights, safety, and well-being of trial subjects are protected Explanation: Good Clinical Practice (GCP) ensures that the rights, safety, and well-being of trial subjects are protected, consistent with the principles that have their origin in the Declaration of Helsinki. What is the main goal of the Good Clinical Practice Guideline? A) To promote international collaboration in clinical research B) To develop new treatments for rare diseases C) To provide a unified standard for clinical trials across different regions D) To increase funding for clinical research C) To provide a unified standard for clinical trials across different regions Explanation: The Good Clinical Practice Guideline aims to provide a unified standard for clinical trials across different regions, making it easier for regulatory authorities to accept clinical data from different countries. Who developed the Good Clinical Practice Guideline? A) The World Health Organization (WHO) B) The European Union (EU) C) The United States Food and Drug Administration (FDA) D) A consortium of international organizations and regulatory agencies D) A consortium of international organizations and regulatory agencies Explanation: The Good Clinical Practice Guideline was developed by a consortium of international organizations and regulatory agencies, including the European Union, Japan, the United States, Australia, Canada, the Nordic countries, and the World Health Organization (WHO). When should Good Clinical Practice be followed? A) Only during Phase I clinical trials B) Only during Phase III clinical trials C) When generating clinical trial data that are intended to be submitted to regulatory authorities D) Never, as it is only a guideline