CDISC标准介绍及在中国的应用
发布时间：2019-01-02 12:39
【摘要】：经过近20年的开发和持续版本升级改进,临床数据交换标准协会(CDISC)已经制定了一套可用于全球临床研究的数据标准,涵盖临床研究的全流程。CDISC标准可提高临床研究和药物评审的质量和效率,便于各方交流研究数据和试验结果。CDISC标准已被多个监管机构用于数据递交标准格式要求或正考虑采用,并在各国业界得到越来越广泛的使用。国内也逐步使用CDISC标准,目前正在进行进一步研究和测试CDISC标准作为中国数据递交格式要求的可行性和路线图。
[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.
【作者单位】： 北京法马苏提克咨询有限公司(PPD);JMP生命科学部 SAS
【分类号】：R95
，
本文编号：2398496
[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.
【作者单位】： 北京法马苏提克咨询有限公司(PPD);JMP生命科学部 SAS
【分类号】：R95
，
本文编号：2398496
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