通過研究天津市傳染病醫(yī)院在藥物臨床試驗工作中具體實施《藥物臨床試驗質(zhì)量管理規(guī)范》（Good Clinical Practice, GCP）的實際情況，探討如何提高臨床試驗質(zhì)量的具體措施。藥品的安全、有效關乎人民的生命健康，因此藥物臨床試驗的科學性與真實性絕對不容質(zhì)疑。做好藥物臨床試驗工作必須保證試驗質(zhì)量，醫(yī)院必須高度重視藥物臨床試驗機構(gòu)的發(fā)展，緊緊把握工作重點，按照GCP及相關法律法規(guī)要求開展工作，建立完善且行之有效的管理體制，規(guī)范試驗流程，加強對醫(yī)護人員的GCP培訓及科研隊伍建設，不斷增強管理意識、提高藥物臨床試驗質(zhì)量。

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.