A pragmatic method for transforming clinical research data from the research electronic data capture "REDCap" to Clinical Data Interchange Standards Consortium (CDISC) Study Data Tabulation Model (SDTM): Development and evaluation of REDCap2SDTM
A pragmatic method for transforming clinical research data from the research electronic data capture "REDCap" to Clinical Data Interchange Standards Consortium (CDISC) Study Data Tabulation Model (SDTM): Development and evaluation of REDCap2SDTM
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DOI：
10.1016/j.jbi.2017.05.003
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发表时间：
2017-06-01
影响因子：
4.5
通讯作者：
Shintani, Ayumi
中科院分区：
文献类型：
--
作者：
Yamamoto, Keiichi;Ota, Keiko;Shintani, Ayumi
临床数据交换标准联盟（CDISC）研究数据列表模型（SDTM）可用于新药申请研究，其次可用于创建临床研究数据仓库，以利用在同一疾病领域内进行的研究中的临床研究数据。然而，目前并非所有临床研究都在研究的设置阶段开始使用临床数据采集标准协调（CDASH）。一旦已经启动，尚未使用CDASH的临床研究就很难以SDTM格式进行映射。此外，大多数电子数据采集（EDC）系统不具备以SDTM格式导出数据的能力;因此，在许多情况下，统计软件用于从累积的临床数据生成SDTM数据集。为了便于使用SDTM有效地二次利用积累的临床研究数据，有必要开发一种新的工具，即使在临床研究期间或之后，也能够映射SDTM的信息。REDCap是由范德比尔特大学开发的EDC系统，在全球108个国家的2100多家机构中使用。在这项研究中，我们开发了一个模拟临床试验，以评估一个名为REDCap 2SDTM的工具，该工具将REDCap的字段注释中的信息映射到SDTM，并执行数据转换，包括当数据必须旋转以适应SDTM格式时，动态地，通过使用R解析映射信息。我们确认使用REDCap 2SDTM从REDCap生成SDTM数据和define.xml文件是可能的。通常，从EDC系统生成SDTM数据和define.xml文件需要为每个临床研究创建单独的程序。然而，我们提出的方法可以用来动态地生成这些数据和文件，而无需编程，因为它只涉及将映射信息输入到字段注释中，并将其他数据输入到特定文件中。我们提出的方法不仅适用于新药应用研究，而且适用于所有类型的研究，包括观察性研究和公共卫生研究。我们的方法也适用于在研究开始时以非标准格式使用CDASH收集的临床数据。我们相信该工具将减少新药申请研究的工作量，并将支持学术界的数据共享和临床研究数据的重用。(C)2017爱思唯尔公司All rights reserved.
The Clinical Data Interchange Standards Consortium (CDISC) Study Data Tabulation Model (SDTM) can be used for new drug application studies as well as secondarily for creating a clinical research data warehouse to leverage clinical research study data across studies conducted within the same disease area. However, currently not all clinical research uses Clinical Data Acquisition Standards Harmonization (CDASH) beginning in the set-up phase of the study. Once already initiated, clinical studies that have not utilized CDASH are difficult to map in the SDTM format. In addition, most electronic data capture (EDC) systems are not equipped to export data in SDTM format; therefore, in many cases, statistical software is used to generate SDTM datasets from accumulated clinical data. In order to facilitate efficient secondary use of accumulated clinical research data using SDTM, it is necessary to develop a new tool to enable mapping of information for SDTM, even during or after the clinical research. REDCap is an EDC system developed by Vanderbilt University and is used globally by over 2100 institutions across 108 countries. In this study, we developed a simulated clinical trial to evaluate a tool called REDCap2SDTM that maps information in the Field Annotation of REDCap to SDTM and executes data conversion, including when data must be pivoted to accommodate the SDTM format, dynamically, by parsing the mapping information using R. We confirmed that generating SDTM data and the define.xml file from REDCap using REDCap2SDTM was possible. Conventionally, generation of SDTM data and the define.xml file from EDC systems requires the creation of individual programs for each clinical study. However, our proposed method can be used to generate this data and file dynamically without programming because it only involves entering the mapping information into the Field Annotation, and additional data into specific files. Our proposed method is adaptable not only to new drug application studies but also to all types of research, including observational and public health studies. Our method is also adaptable to clinical data collected with CDASH at the beginning of a study in non-standard format. We believe that this tool will reduce the workload of new drug application studies and will support data sharing and reuse of clinical research data in academia. (C) 2017 Elsevier Inc. All rights reserved.