CDISC标准介绍及在中国的应用
Overview of CDISC standard and implementation in China
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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: CDISC standard has become a set of global data standards that can be used in clinical study, covering the full life cycle of clinical researches. After nearly 20 years of development and continuous version upgrades, CDISC standard can improve the quality and efficiency of clinical research and drug review, and to facilitate all stakeholders involved in researches to exchange the study data and communicate the outcomes. CDISC standard has been or is to be adopted as standard format in data submission by multiple regulatory authorities, and more widely implemented by the global pharmaceutical community. CDISC standard is gradually adopted in China. The feasibility and roadmap of CDISC standard as the Chinese data submission format requirements are undergoing exploration and piloting further.
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