Good Clinical Practice question with 100% correct answers 2023/2024

Good Clinical Practice The ICH E6 guideline should be followed when: A. Generating clinical trial data that are intended to be submitted to regulatory authorities B. Conducting studies under a U.S. Investigational New Drug (IND) application or Investigational Device Exemption (IDE) C. Generating quality improvement and quality assurance data D. Conducting device studies under a Canadian Investigational Testing Authorization (ITA) - correct answer A. Generating clinical trial data that are intended to be submitted to regulatory authorities. ICH E6 describes standards that apply to: A. Research B. IRBs only C. Investigators, sponsors, Institutional Review Board (IRBs) / Independent Ethics Committees (IECs) / Research Ethics Boards (REBs) D. Investigators only - correct answer C. Investigators, sponsors, and Institutional Review Boards (IRBs) / Independent Ethics Committees (IECs) / Research Ethics Boards (REBs). ICH topics and guidelines fall into four main categories: A. Sponsor, Investigator, Statistical Analysis, Trial Management B. Quality, Safety, Efficacy, Multidisciplinary C. Sponsor, Investigator, Statistical Analysis, Research Ethics D. Quality, Security, Efficiency, Multidisciplinary - correct answer B. Quality, Safety, Multidisciplinary. The two important goals of the ICH E6 standard are: