ICH Harmonized Guideline for GCP E6 (R2) well answered 2023/2024

ICH Harmonized Guideline for GCP E6 (R2) What is ICH? - correct answer International Council for Harmonization ICH Harmonized Guideline for Good Clinical Practice - correct answer GCP document describes the responsibilities and expectations of all participants in the conduct of clinical trials, including investigators, monitors, sponsors and IRBs What is GCP? - correct answer international ethical and scientific quality standard for designing, conducting, recording, and reporting trials that involve participation of human subjects What does GCP cover? - correct answer Aspects of monitoring, reporting and archiving of clinical trials and incorporating addenda on the Essential Documents and on the Investigators Brochures which had been agreed earlier through the ICH process Providing a unified standard for Europe, US, and Japan to facilitate the acceptance of clinical trials is the... - correct answer Mission statement of the ICH What are the principles of ICH GCP (10)? - correct answer 1) Clinical trials should be conducted in accordance with the ethical principles that have their origin in the Declaration of Helsinki, and that are consistent with GCP and the applicable regulatory requirement(s) 2) Before a trial is initiated, foreseeable risks and inconveniences should be weighed against the anticipated benefit for the individual trial subject and society. A trial should be initiated and continued only if the anticipated benefits justify the risks 3) The rights, safety, and well-being of the trial subjects are the most important considerations and should prevail over interests of science and society 4) The available non-clinical and clinical information on an investigational product should be adequate to support the proposed clinical trial 5) Clinical trials should be scientifically sound, and described in a clear, detailed protocol 6) A trial should be conducted in compliance with the protocol that has received prior institutional review board (IRB)/independent ethics committee (IEC) approval/favorable opinion