臨床試驗(yàn)機(jī)構(gòu)能力評(píng)估系列標(biāo)準(zhǔn)包括臨床試驗(yàn)機(jī)構(gòu)能力評(píng)估標(biāo)準(zhǔn)、倫理委員會(huì)審查能力評(píng)估標(biāo)準(zhǔn)、臨床試驗(yàn)專業(yè)組能力評(píng)估標(biāo)準(zhǔn)、Ⅰ期臨床試驗(yàn)?zāi)芰υu(píng)估標(biāo)準(zhǔn)、生物樣本分析檢測(cè)能力評(píng)估標(biāo)準(zhǔn)。既可以綜合對(duì)臨床試驗(yàn)機(jī)構(gòu)進(jìn)行整體評(píng)估，也可以獨(dú)立進(jìn)行單項(xiàng)評(píng)估。標(biāo)準(zhǔn)中同時(shí)規(guī)定了評(píng)估結(jié)果判定方式。以期能夠切實(shí)促進(jìn)臨床試驗(yàn)機(jī)構(gòu)的規(guī)范化運(yùn)行與監(jiān)管，促進(jìn)臨床試驗(yàn)機(jī)構(gòu)及臨床試驗(yàn)從業(yè)人員自律，加速我國(guó)臨床試驗(yàn)研究國(guó)際化進(jìn)程，提升臨床試驗(yàn)研究與管理水平。

The series of standard for capacity assessment of clinical trial institution includes the capacity assessment standard for clinical trial institution, the review capacity assessment standard for Ethics committee, the capacity assessment standard for clinical trial professional group, the capacity assessment standard for phase I clinical trial, the capacity assessment standard for biological sample analysis and detection. Both the overall evaluation of the clinical trial institution and the individual evaluation can be carried out independently from the above five aspects. At the same time, the evaluation result decision method is specified in the standard. The purpose is to promote the standardized management of the operation and supervision of clinical trial institutions, promote the self-discipline of practitioners in clinical trials institutions, accelerate the internationalization of clinical trial research in China, and improve the management and research level of clinical trials.

R951