ICH E6 (R2) - Good Clinical Practice Questions and Answers | Latest Update | 2024/2025 | Graded A+

ICH E6 (R2) - Good Clinical Practice Questions and Answers | Latest Update | 2024/2025 | Graded A+ What essential aspects should an IRB/IEC safeguard for all trial participants? Choose from the following options: a) Confidentiality, integrity, and accountability b) Rights, safety, and well-being b) Rights, safety, and well-being What documents should an IRB/IEC obtain prior to reviewing a clinical trial? Select from the following options: a) Investigator's personal records b) Trial protocol(s), informed consent form(s), and related documents b) Trial protocol(s), informed consent form(s), and related documents How should an IRB/IEC document its review outcome for a clinical trial? Choose from the following options: a) Verbal notification only b) Written notification with details about the trial, documents reviewed, and dates c) A combination of written and verbal notification b) Written notification with details about the trial, documents reviewed, and dates What should an IRB/IEC consider when evaluating the qualifications of an investigator for a proposed trial? Choose from the following options: a) A current resume and/or any other relevant documentation requested by the IRB/IEC b) A detailed medical history of the investigator c) The investigator's personality traits a) A current resume and/or any other relevant documentation requested by the IRB/IEC How often should an IRB/IEC conduct continuing review of an ongoing trial? Choose from the following options: