境內(nèi)第二類體外診斷試劑臨床試驗申請資料

test4 · 發(fā)表于 2018-8-1 10:14:18

　　根據(jù)體外診斷試劑注冊管理辦法的規(guī)定，需要進行臨床試驗的體外診斷試劑，申請人應當參考有關技術指導原則在不少于2家(含2家)省級衛(wèi)生醫(yī)療機構開展臨床試驗，并提交下列臨床試驗資料：

　　一、倫理委員會同意臨床試驗開展的書面意見。

　　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(tǒng)計學負責人簽名及單位蓋章、申請人蓋章、倫理委員會蓋章。

　　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、試驗開始日期、試驗完成日期、主要研究者簽名、試驗機構蓋章、統(tǒng)計學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。

　　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(nèi)容與各臨床試驗機構的臨床試驗報告的封面內(nèi)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)品來源、產(chǎn)品說明書及注冊批準情況，臨床試驗中所有試驗數(shù)據(jù)（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，主要研究者簡歷，以及申請人需要說明的其他情況等。

gqtmr · 發(fā)表于 2019-5-13 09:52:05

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kxuzg · 發(fā)表于 2019-5-12 03:08:13

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