境內第二類(lèi)體外診斷試劑臨床試驗申請資料

test4

　　根據體外診斷試劑注冊管理辦法的規定，需要進(jìn)行臨床試驗的體外診斷試劑，申請人應當參考有關(guān)技術(shù)指導原則在不少于2家(含2家)省級衛生醫療機構開(kāi)展臨床試驗，并提交下列臨床試驗資料：

　　一、倫理委員會(huì )同意臨床試驗開(kāi)展的書(shū)面意見(jiàn)。

　　二、臨床試驗方案：由各承擔臨床試驗的主要研究者簽名、臨床試驗機構蓋章、統計學(xué)負責人簽名及單位蓋章、申請人蓋章、倫理委員會(huì )蓋章。

　　三、各臨床試驗機構的臨床試驗報告：各臨床試驗機構的試驗報告應由臨床試驗機構簽章；報告封面包括試驗用體外診斷試劑的通用名稱(chēng)、試驗開(kāi)始日期、試驗完成日期、主要研究者簽名、試驗機構蓋章、統計學(xué)負責人簽名及單位蓋章、申請人蓋章、申請人的聯(lián)系人及聯(lián)系方式、報告日期、原始資料保存地點(diǎn)。

　　四、對所有臨床試驗結果的總結報告：總結報告由臨床試驗機構的牽頭單位或者申請人完成，封面內容與各臨床試驗機構的臨床試驗報告的封面內容相同。

　　五、臨床試驗報告附件：臨床試驗的詳細資料，包括臨床試驗中所采用的其他試驗方法或者其他診斷試劑產(chǎn)品的基本信息，如試驗方法、診斷試劑產(chǎn)品來(lái)源、產(chǎn)品說(shuō)明書(shū)及注冊批準情況，臨床試驗中所有試驗數據（需由臨床試驗操作者、復核者簽字，臨床試驗機構蓋章），主要參考文獻，主要研究者簡(jiǎn)歷，以及申請人需要說(shuō)明的其他情況等。

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