藥物臨床試驗是新藥研發(fā)過程中極其重要的階段，臨床試驗完成質(zhì)量的高低直接關(guān)系到人類的生命與健康，因此必須保證藥物的安全、有效和質(zhì)量控制。專職研究護士在現(xiàn)今的藥物臨床研究試驗中扮演著多重角色，對臨床試驗的質(zhì)量起到了一定的保障作用。依據(jù)臨床試驗的相關(guān)法律法規(guī)，結(jié)合自身工作經(jīng)驗，淺析臨床試驗中常見問題發(fā)生的原因、處理及預(yù)防措施，以期提高專職研究護士的作用，從而提升藥物臨床試驗的質(zhì)量。

Drug clinical trial is an extremely important stage in the process of new drug research and development. The quality of clinical trial completion is directly related to human life and health. So, it is necessary to ensure the safety, effectiveness and quality control of drugs. Full-time research nurses play multiple roles in today's drug clinical research trials and play a certain role in guaranteeing the quality of clinical trials. Based on the relevant laws and regulations of clinical trials, combined with the author's own work experience, this paper analyzed the causes, treatment and preventive measures of common problems in clinical trials, with a view to improving the role of full-time research nurses and improving the quality of drug clinical trials.

R288.4

北京醫(yī)衛(wèi)健康公益基金會課題（YWJKJJHKYJJ-B184091-Q21）