2026-11-092026-11-09https://scholars.csmu.edu.tw/handle/123456789/38533Chung-Shan Medical University Hospital has been co-operated with Department of Health (DOH) to drive the plan “promoting the reward of People be trained for clinical trial” under the plan “establish the national clinical trial research system” in the plan “the plan of biomedical technologic island”. We have been set up the general clinical trial center under the organization “department of education & research”. We will actively enhance the quality of clinical trial conform to ethics of human trial, Good Clinical Practice (GCP), Good Laboratory Practice (GLP), Good Tissue Practice (GLP) and related rules. To match up the development of DOH “GCRC plan”, our hospital actively recruited excellent medical-related people who are involve in clinical research. From 2006, people who were under the support of plan “Rewarding medical researchers for joining clinical trials.” include doctor, pharmacist, nurse and statistician. These subsidy make them can stably take office in Chung-Shan Medical University clinical trial center and to be responsible for their job which accept sponsor authorization. Besides, our staffs provide consultation, guidance and assistance, latest related-information and richly well support to colleagues in our hospital. The plan focus on training program including early trial design, protocol writing, apply and examine, which can reach the regulation of laws. Drug dispensing, storage, manage and case report form record, maintain secrecy are the other one important event also.中山醫學大學附設醫院為加強臨床研究水準，並配合衛生署有效推動「生醫科技島計畫」下之「建立國家臨床試驗與研究體系」中的「推動臨床試驗人才培育獎助及教育訓練」之計畫，設立「臨床試驗中心，我們將以符合人體試驗倫理、法規管理、藥品優良臨床試驗規範（GCP）、優良實驗室規範等相關規範（GLP）、人體細胞組織優良操作規範（GTP）等為準則，積極全方面提昇臨床試驗的品質。 配合政府推動聲醫科技島之生技製藥產業政策及衛生署GCRC及全面提升藥物上市臨床試驗之關鍵環境計畫項下，本院積極自我提升、提供相關產業界高品質臨床是按執行場所。本院臨床試驗中心招攬優秀醫事人員從事臨床試驗的執行與發展，自九十五年九月起，榮獲衛生署『獎助醫療機構之醫事人員從事臨床研究』計畫申請補助，人員包括醫師、藥師、護理師及統計師，全方位提升各項臨床試驗相關軟硬體，積極招募執行臨床試驗優秀人才。這些人才目前均任職於中山附醫臨床試驗中心，善盡試驗相關職責，除提供院內諮詢外，教育指導與協助本院的同仁們能獲得最新且正確的相關知識，以及良善豐富的各項技術人力支援。本計畫以「推動臨床試驗人才培育獎助及教育訓練」為重點，培訓專職臨床試驗的相關人員，使包括從最初臨床試驗設計、計畫書撰寫、案件的申請與送審等，均能符合科學、倫理及法規要求，臨床試驗用藥的配製、儲存、管理皆合乎安全規定，受試者相關資料與病歷之保管，亦需要注意隱私保密及完整性。藥品優良臨床試驗準則臨床試驗新藥研發good clinical practiceclinical trialnew drug developementProject