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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。
After nearly 20 years of development and ongoing version upgrades, the Clinical Data Exchange Standards Association (CDISC) has developed a set of data standards that can be used for global clinical research covering the full flow of clinical research. The CDISC standard improves the quality and efficiency of clinical research and drug reviews so that all parties can exchange research data and test results. The CDISC standard has been used by multiple regulators for data submission standard formats or is being considered for adoption and is gaining more and more widespread use in all industries. The CDISC standard is gradually being used domestically, and the feasibility and roadmap for further research and testing of the CDISC standard as a data format for submission to China are under way.