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      您所在的位置:首頁 > 政策解讀 > 《青海省臨床醫學研究中心暫行管理辦法》解讀

      《青海省臨床醫學研究中心暫行管理辦法》解讀

      瀏覽次數:2656信息來源:|1發布時間:2018-11-02 16:31:33文字大小: 打印

        一、臨床醫學研究中心建設宗旨
        以臨床應用為導向,以醫療機構為主體,以協同網絡為支撐,著重開展臨床研究、協同創新、學術交流、人才培養、成果轉化、推廣應用,充分發揮優勢醫療科研資源,在主要疾病領域和臨床專科布局建設省級臨床醫學研究中心,與國家級臨床醫學研究中心和分中心銜接,積極融入國家創新平臺系列,為青海省臨床醫學科技創新發展、造福惠及百姓提供有力支撐。
        二、起草背景
        根據科技部社發司召開的全國社會發展科技創新工作會議精神和各省社會發展科技管理工作推進經驗,為加快醫學創新體系建設,科技部在11個疾病領域布局了32個國家臨床醫學研究中心,搭建了聯合260個地級以上城市的2100余家醫療機構的協同創新網絡,開展疾病防控技術研究,各地方也建有近200個省級臨床醫學研究中心。國家臨床醫學研究中心已正式作為技術創新與成果轉化類國家科研基地納入《國家科技創新基地優化整合方案》(國科發基〔2017〕250號)中,與國家重點實驗室等創新基地并列,成為我國科技創新體系的重要組成部分。2017年10月科技部、國家發展改革委、財政部聯合印發了《“十三五”國家科技創新基地與條件保障能力建設專項規劃》(國科發基〔2017〕322號),明確加強國家臨床醫學研究中心的布局。探索省部共建中心的建設,引導重大疾病領域的分中心建設,鼓勵省級中心建設。
        青海省包蟲病、高原醫學等疾病控制技術在國家層面都有重要引領示范作用。為集成青海優勢醫療科研資源,發揮好中心引領、集成、帶動、普及作用,為我省臨床醫學科技發展提供科技支撐。根據《國家臨床醫學研究中心管理辦法》,借鑒兄弟省管理經驗,結合青海實際,青海省科技廳會同青海省衛生和計劃生育委員會、青海省食品藥品監督管理局聯合制定了《青海省臨床醫學研究中心暫行管理辦法》。于2018年7月9日印發,8月9日起正式實施,有效期至2020年8月8日。
        三、主體框架
        文件共六章31條。
        第一章 總 則,共4條(第一條到第四條),介紹了管理辦法制定的依據、中心定位、發展目標、管理要求。
        第二章 組織管理,共6條(第五條到第十條),介紹了中心的管理部門、職責、支持方式;中心專家咨詢委員會組成、職責;中心的職責及任務;依托單位任務,以及充分發揮相關專業機構、行業學會等的作用。
        第三章 申報和評審,共7條(第十一條到第十七條),規定了包括通知發布、申報條件、報送要求、評審程序、確定依托單位、公示和發文確認等具體要求。
        第四章 建設運行管理,共8條(第十八條到第二十五條),規定了建設方案編制和中心建設具體要求。
        第五章 績效評估,共4條(第二十六條到第二十九條),規定了每兩年開展一次績效評估,評估內容和評估結果及具體的獎勵支持。
        第六章附則,共2條(第三十條到第三十一條)。規定了命名和實施有效期。
        四、幾點說明
        1、中心主要圍繞已建成的國家臨床研究中心進行規劃與布局,在中心定位、發展目標,實施的重點任務和運行管理機制等方面進行謀劃設計,銜接國家臨床資源,提升青海省重大疾病的防控診治水平,為群眾醫療健康服務提供有效支撐。    
        2
      中心的職責及任務。
        ①對接本領域國家臨床級中心爭取納入協同網絡成員,創建成為國家臨床研究中心分中心;
        ②緊密圍繞本領域疾病防治的重大需求和臨床研究中存在的共性技術問題,研究提出本領域研究的戰略規劃和發展重點;
        ③優選省內外醫療機構和相關研究單位搭建協同創新網絡,負責網絡成員單位的績效考核,培育臨床研究人才;
        ④組織、參與開展循證評價研究;開展防、診、治新技術、新方法的研究和應用評價;開展診療規范和療效評價研究;開展基礎與臨床緊密結合的轉化醫學研究等;
        ⑤搭建健康醫療大數據、樣本資源庫等臨床研究公共服務平臺;
        ⑥研究提出診療技術規范建議和相關政策建議,供行業主管部門參考;
        ⑦組織開展研究、引進集成臨床技術成果并轉化應用,提升本領域疾病診療技術水平和服務能力。
        3、中心實施定期評估和績效動態管理,原則上每兩年開展一次績效評估。依據績效評估結果,對通過評估的中心,省級科技計劃按照實際需求予以滾動支持;對未通過的中心,予以通報并責成限期整改;對整改后仍未通過評價的中心予以撤銷。
        4、中心建設要求具有國家藥物臨床試驗機構(GCP)資格或經過藥物醫療器械臨床試驗機構備案緊密貫徹落實國家和省臨床試驗機構管理相關規定,支持臨床試驗機構和人員開展臨床試驗。

      作者:青海省科學廳

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