2026-11-092026-11-09https://scholars.csmu.edu.tw/handle/123456789/38388The Department of Health (DOH) is considering to protect the subjects who participate in clinical trials, and to keep the higher quality of all kinds of clinical trials in Taiwan. They have relaxed the policy of the hospital level restriction. In the aspect of capacity, the trial conducting places are expanding to the teaching hospitals and some special qualified hospitals. We expect that the quality of ourselves should also be promoted at the same time, thus we can establish the good clinical trials. We should pay more attention to the trial subjects’ welfare and also promote the progression of medical research. Chung Shan Medical University Hospital co-operate with governmental Department of Health (DOH) to promote the system of clinical research and environmental construction of clinical trial, and set up the infrastructure as the “Drugs, Medical Instruments and New Medical Techniques Clinical Trial Center”.衛生署在考量積極保護受試病人，且不影響臨床試驗執行品質的前提下，已放寬臨床試驗執行醫院層級。在『量』的方面，將試驗執場所，由原本17家醫學中心，增加為126家評鑑合格之教學醫院及經衛生署認定之專科醫院。我們期許，自我本身「質」的方面，也需同步的提昇，方能設計於執行『好』的臨床試驗，以維護“病患福祉”為首要之考量，並兼顧醫學研究展。中山醫學大學附設醫院為加強臨床試驗水準，並配合衛生署「健全新藥臨床試驗體系與運作機制」之計劃，目前在教研部下設「臨床試驗中心(Clinical Trail Center)」，編列專人負責，已經具備有臨床臨床試驗管理機構(Site Management Organization,SMO)的完整觀念與管理模式。中山醫學大學附設醫院要求同仁再在追求醫藥科學發展與尊重道德倫理中，結合現有資源與設備，使臨床試驗運作更臻完善，加強全院醫事人員的自我管理與提升，更能為創造一個溫馨、合理的人體臨床試驗環境，注入生命力。臨床試驗新藥研發clinical trialnew drug developmentProject