臨床試驗(yàn)檔案是臨床試驗(yàn)管理的重要組成部分和臨床試驗(yàn)的重要環(huán)節(jié)，臨床試驗(yàn)檔案管理是否規(guī)范直接關(guān)系到對臨床試驗(yàn)的科學(xué)性、真實(shí)性、準(zhǔn)確性及可靠性評價(jià)，也關(guān)系到受試者權(quán)益保護(hù)。主要論述《臨床試驗(yàn)機(jī)構(gòu)檔案管理專家共識》的起草背景、制定依據(jù)和適用范圍，以及臨床試驗(yàn)檔案管理要求、管理的主要環(huán)節(jié)，非紙質(zhì)介質(zhì)檔案管理的特殊要求、專業(yè)科室臨床試驗(yàn)資料管理要求，以期加強(qiáng)臨床試驗(yàn)機(jī)構(gòu)檔案規(guī)范化管理，有效保護(hù)和利用臨床試驗(yàn)檔案，確保臨床試驗(yàn)機(jī)構(gòu)檔案完整、準(zhǔn)確、可用、安全。

Clinical trial archives are an important part of clinical trial management and an important link of clinical trials. Whether the management of clinical trial archives is standardized is directly related to the scientific, authentic, accurate and reliable evaluation of clinical trials, as well as the protection of the rights and interests of subjects. This paper mainly discusses the drafting background, formulation basis and application scope of the standard "Expert consensus for archives management of clinical trial institutions", as well as the requirements and main links of the management of clinical trial archives, the special requirements for the management of non-paper media archives, and the requirements for the management of clinical trial materials of professional departments, with a view to strengthening the standardized management of clinical trial institutions' archives, effectively protecting and utilizing clinical trial archives, and ensuring the integrity accurate, usable and safe.

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北京中醫(yī)醫(yī)院院級課題暨兩院合作項(xiàng)目（LY201801，LY201807）；國家“十三五”重大新藥創(chuàng)制專項(xiàng)課題（2019ZX09734001）