基于SDTMdefinexml元数据自动化检查的SAS宏实现.doc

基于SDTM define?xml元数据自动化检 查的SAS宏实现 朱欢刘玉秀于浩 南京医科大学公共卫生学院南京医科大学金陵临床 医学院(南京军区南京总医院)医学统计学教研室 摘要： 目前，FDA明确规定中办者向其递交的临床试验电子评审材料需要基于CDISC ODM (Operational Data Model)模型的 SDTM define, xml 作为用于新药注册评 审的必备文件之一。尽管近几年业内已有多家企业致力于开发自动化工具生成 SDTM define, xml，但在核查策略和质量控制方面的系统性研究不多，工作人员 仍需花费大量时间进行人工核查。本研究旨在对生成SDTM define, xml的元数据 模块建立一套全面综合的核查策略和关键核查点，并通过编制SAS宏实现这些 核查点的自动化核查和质量控制，使得递交给FDA的SDTM define, xml所包含信 息准确无误，数据之间具有良好的追踪性，同吋大大降低人力成本，提高效率。 关键词： FDA; CDISC; SDTM; define, xml;自动化检查;ODM; 作者简介：朱欢，女，硕士研究生，研究方向：临床试验统计方法学。 Tel-mail:962438977@qq. com 作者简介：于浩，通信作者，女，教授，研究方向：临床试验统计方法学研究及 应用。Tel:-mail: njyuhao@vip. sina. com 收稿日期：2017-09-29 Automated inspection for SDTM define, xml based on metadata via SAS macro ZHU Huan LIU Yuxiu YU Hao School of Public Hea1th, Nanjing Medical University; Department of Medical Statistics, Jinling Clinical Medical College, Nanjing Medical University; Abstract： Nowadays, FDA has specifically cstablishccl the rules of electronic review files for drug submission. SDTM define? xml, which is based on CDISC ODM (Operational Data Model) , has been used as one of the essential documents for FDA review. In recent years many pharmaceutical and CRO companies devote themselves to developing tools to realize automated SDTM define, xml gencreition. But in terms of quality control, little research is carried out; therefore, people need to spend more time on manual check. The purpose of this research is to create a set of comprehensive checklist based on SDTM define, xml metadata, and realize automated inspection and quality control systematically for these checkpoints via SAS macro. As a result，to ensure all info in SDTM define, xml is correct and kept good traceability by decreasing the human cost and raise efficiency at the same time. Keyword： FDA; CDISC; SDTM; define, xml; automated inspection; ODM; Received： 2017-09-29 临床数据交换标准协会(Clinical Data Interchange Standards Consortium, CDISC)是一个全球性的、开放的、多学科的、非盈利性的组织，通过建立一系 列临床研究数据的标准IH，用于收集、交换、提交和归档临床