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

Good Clinical Practice Questions and Answers | Latest Version | 2024/2025 | Already Passed The ICH E6 guideline is essential when: a. Collecting data for regulatory submission purposes b. Conducting studies under a U.S. IND or IDE application c. Gathering quality improvement and quality assurance data d. Conducting device studies under a Canadian ITA ICH E6 outlines standards that apply to: a. Clinical research teams only b. IRBs only c. Investigators, sponsors, and IRBs/IECs/REBs d. Researchers only ICH topics and guidelines can be categorized into four main areas: a. Sponsorship, statistical analysis, and trial management b. Quality, safety, multidisciplinary approaches c. Sponsorship, investigator roles, and statistical analysis d. Quality, security, efficiency, and multidisciplinary approaches The primary objectives of the ICH E6 standard are: a. To ensure site selection and timely data reporting b. To protect patient rights, well-being, and confidentiality; ensure timely data reporting c. To protect patient rights, well-being, and confidentiality; ensure credible trial data d. To provide access to clinical trials for all patients; ensure credible trial data A primary purpose of the ICH E6 guideline is to: A. Require registration of clinical trials B. Require publication of negative trial results C. Develop mandatory worldwide regulations for drug development D. Minimize the need for redundant research