查詢結果分析
來源資料
頁籤選單縮合
題 名 | 建立中藥新藥臨床試驗GCP查核作業計畫=GCP Inspection on Clinical Research Centers which Received Support from the Committee on Chinese Medicine and Pharmacy |
---|---|
作 者 | 郭英調; | 書刊名 | 中醫藥年報 |
卷 期 | 光碟版1:9 2012.10[民101.10] |
頁 次 | 頁800-819 |
專 輯 | 中醫藥產業實務規範 |
分類號 | 414.53 |
關鍵詞 | 中藥新藥臨床試驗中心; 查核; 藥品優良臨床試驗規範; GCRC; Inspection; GCP; |
語 文 | 中文(Chinese) |
中文摘要 | 國內多家醫院,經過行政院衛生署中醫藥委員會多年努力推動及國內學者專家的協助下,已陸續成立「中藥新藥臨床試驗中心」。100年度共有七家醫院獲得中醫藥委員會補助。包括:中山醫學大學附設醫院、成大醫院、慈濟醫院台中分院、中國醫藥大學附設醫院、長庚醫院、屏東基督教醫院及義大醫院。為了解及提升中藥新藥臨床試驗中心的執行狀況與運作品質,中醫藥委員會委託執行本查核計畫。 本查核計畫在實地查核前先召開共識說明會。各查核委員對查核目標、方向及「查核紀錄表」的評分標準獲得共識同時亦查核執行中的 6件中藥臨床試驗計畫及 5件研發組計畫。排定時間及委員後,分別至各家「中藥新藥臨床試驗中心」進行查核。全部查核結束後再召開查核結果確認會議。除查核委員說明查核時的所見所聞以外,對各家「中藥新藥臨床試驗中心」及其臨床試驗的執行情形進行確認,以避免個人差異。 為避免因為每年評分標準不一,分數高低造成誤導。評定會議時,委員一致同意,本年度試驗中心的查核成果,改以排序的方式做最後的總評,不列分數。提供中醫藥委員會作為下年度補助的參考。 |
英文摘要 | The importance of inspection for enforcement of Good Clinical Practice (GCP) compliance cannot be over-emphasized. The definition of Good Clinical Practice (GCP) is “A standard for the design, conduct, performance, monitoring, auditing, recording, analyses, and reporting of clinical trials that provides assurance that the data and reported results are credible and accurate, and that the rights, integrity , and confidentiality of trial subjects are protected.”. And the definition of inspection is given as “The act by a regulatory authority(ies) of conducting an official review of documents, facilities, records, and any other resources that are deemed by the authority(ies) to be related to the clinical trial and that may be located at the site of the trial, at the sponsor’s and/or contract research organization’s (CRO’s) facilities, or at other establishments deemed appropriate by the regulatory authority(ies).” This project is to execute the GCP inspection on 7 clinical research centers which received support from the Committee on Chinese Medicine and Pharmacy. All 7 clinical research centers which received support from the Committee on Chinese Medicine and Pharmacy have been visited after consensus has been made by all inspectors. There are 6 project and 5 research protocols have been inspected. The result has been confirmed and re-scored in confirmation meeting after all data collected. The sequence of superiority of each research centers was determined in the confirmation meeting. The result was submit to the Committee on Chinese Medicine and Pharmacy. |
本系統中英文摘要資訊取自各篇刊載內容。