2026-11-092026-11-09https://scholars.csmu.edu.tw/handle/123456789/38752To match up the development of DOH “Establishing General Clinical Research Center (GCRC) and relatedlaboratory” and “Fully improve the key environment of pre-marketing clinical trials”, 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. The contents have been included the form of protocol, practice of work, written the inform consent form, rule of drug management, report of adverse events, data analysis, related site audit and training program.自九十五年九月起，本院臨床試驗中心榮獲衛生署『獎助醫療機構之醫事人員從事臨床研究』計畫之補助，積極延攬優秀醫事人員從事臨床試驗，包括醫師、藥師、護理師及統計師；並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，充實臨床試驗中心各項軟硬體。本院臨床試驗中心提供生技製藥產業界高品質臨床試驗執行場所。這些人才提供經驗並並提供院校內外臨床試驗之諮詢，教育與協助本院的同仁們能獲得最新且正確的相關知識，並提供各項技術人力支援。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、管理皆合乎規定，受試者相關資料與病歷之保管，亦需符合保護隱私及達到保密之規範。 本中心積極朝向臨床試驗管理機構 (SMO) 邁進，全方位管理或支援本院校內外所有臨床試驗的方向進行，同時提供試驗設計諮詢及各項執行協助。透過本計畫的獎勵，對於本院臨床試驗相關人才的培訓與穩定，具有非常重大的助益。藥品優良臨床試驗準則臨床試驗新藥研發good clinical practiceclinical trialnew drug developementProject