PH 3114 - Good Clinical Practice question n answers graded A+ 2023/2024

PH 3114 - Good Clinical PracticeWhat is GCP? - correct answer Ethical and scientific quality standards for designing, conducting, recoding and reporting trials that involve participation of human subjects. It can be regarded as total quality management of clinical trials procedures Why is GCP needed? - correct answer To ensure that the rights, safety and wellbeing of the trial subjects are protected. Ensure the credibility of clinical trial data Why has GCP developed into formal guidelines? - correct answer Public disasters, serious fraud and abuse of humans rights What do GCP guidelines do? - correct answer Mainly focus on the protection of human rights in clinical trial. Provide assurance of the safety of new compounds. provide standards of how clinical trials should be conducted. Define the roles and responsibilities of clinical sponsors, clinical research investigators, clinical research associates and monitors. What are GCP guidelines defined as? - correct answer As an international ethical and scientific standard for designing, conducting, recording and reporting trials that involve the participation of human subjects What is the first principle? - correct answer studies in accordance with declaration of Helsinki; consistent with GCP and applicable regulatory requirements. What is the 2nd principle of GCP? - correct answer Studies initiated and continued only if anticipated benefits outweigh risks. What is the 3rd principle of GCP? - correct answer Rights, safety and welfare of human subjects take priority over interests of science and society What is the 4th principle of GCP? - correct answer Available non-clinical and clinical information on product adequate to support study