【摘要】：經(jīng)過(guò)近20年的開(kāi)發(fā)和持續(xù)版本升級(jí)改進(jìn),臨床數(shù)據(jù)交換標(biāo)準(zhǔn)協(xié)會(huì)(CDISC)已經(jīng)制定了一套可用于全球臨床研究的數(shù)據(jù)標(biāo)準(zhǔn),涵蓋臨床研究的全流程。CDISC標(biāo)準(zhǔn)可提高臨床研究和藥物評(píng)審的質(zhì)量和效率,便于各方交流研究數(shù)據(jù)和試驗(yàn)結(jié)果。CDISC標(biāo)準(zhǔn)已被多個(gè)監(jiān)管機(jī)構(gòu)用于數(shù)據(jù)遞交標(biāo)準(zhǔn)格式要求或正考慮采用,并在各國(guó)業(yè)界得到越來(lái)越廣泛的使用。國(guó)內(nèi)也逐步使用CDISC標(biāo)準(zhǔn),目前正在進(jìn)行進(jìn)一步研究和測(cè)試CDISC標(biāo)準(zhǔn)作為中國(guó)數(shù)據(jù)遞交格式要求的可行性和路線圖。
[Abstract]:After nearly 20 years of development and continuous versioning improvements, the Association of Clinical data Exchange Standards (CDISC) has developed a set of data standards that can be used in clinical research around the world. CDISC standards can improve the quality and efficiency of clinical research and drug review, CDISC standards have been used by many regulators to submit data to standard format requirements or are being considered for adoption, and are increasingly widely used in various countries. CDISC standard is also being used in China, and the feasibility and roadmap of CDISC standard as a data submission format requirement in China are being further studied and tested.
【作者單位】： 北京法馬蘇提克咨詢有限公司(PPD);JMP生命科學(xué)部 SAS
【分類號(hào)】：R95
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本文編號(hào)：2398496