GCP与临床试验质量管理

通过研究天津市传染病医院在药物临床试验工作中具体实施《药物临床试验质量管理规范》(Good Clinical Practice,GCP)的实际情况,探讨如何提高临床试验质量的具体措施.药品的安全、有效关乎人民的生命健康,因此药物临床试验的科学性与真实性绝对不容质疑.做好药物临床试验工作必须保证试验质量,医院必须高度重视药物临床试验机构的发展,紧紧把握工作重点,按照GCP及相关法律法规要求开展工作,建立完善且行之有效的管理体制,规范试验流程,加强对医护人员的GCP培训及科研队伍建设,不断增强管理意识、提高药物临床试验质量.

GCP and quality management of clinical trial

To discuss how to improve the quality of clinical trials through the research on the implement of Good Clinical Practice (GCP) in the clinical trial in Tianjin Infectious Disease Hospital, Drug safety and efficacy are important for the health of human being, so there should be no doubt on the scientificity and truth of drug clinical trial. To make sure the drug clinical trial, test quality should be assured, hospital should attach the great importance to the drug clinical trial institution development, firmly grasp the work key, in accordance with the GCP and the requirements of relevant laws and regulations in order to carry out the work, build perfect and effective management system, make the test procedures standardized, strengthen the staff training and research, establish the GCP team building, continuously enhance the management consciousness, and improve the quality of drug used in clinical trial.