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- W2183241842 abstract "Dataset-XML defines a new CDISC XML standard format for transporting tabular data in XML between any two entities. That is, in addition to supporting the transport of data sets as part of a submission to the FDA, it may also be used to facilitate other data interchange use cases. For example, the Dataset-XML data format can be used by a CRO to transmit SDTM or ADaM data sets to a sponsor organization. Dataset-XML supports SDTM, ADaM, and SEND CDISC data sets but can also be used to exchange any other type of tabular data set. In 2014 the FDA conducted a pilot to evaluate Dataset-XML as a solution to the challenges of the SAS XPORT v5 transport format. The metadata for a data set contained within a CDISC Dataset-XML document must be specified using the CDISC DefineXML standard. Each CDISC Dataset-XML document contains data for a single data set, but a single CDISC Define-XML file describes all the data sets included in the folder. Both CDISC Define-XML v1.0 and CDISC Define-XML v2.0 are supported for use with CDISC Dataset-XML. This paper will introduce the Dataset-XML standard and present SAS based tools to transform between SAS data sets and Dataset-XML documents, including validation. This paper assumes that the reader is familiar with some basic XML concepts, and also with the CDISC Define-XML standard for exchanging metadata. Reference [1] contains both a short overview of the XML needed to understand this paper, and also an overview of the structure of a define.xml file based on Define-XML version 1.0.0. A detailed overview of differences between CRT-DDS version 1.0.0 and Define-XML version 2.0.0 can be found in “Define-XML v2 - What’s New” [2]." @default.
- W2183241842 created "2016-06-24" @default.
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- W2183241842 date "2015-01-01" @default.
- W2183241842 modified "2023-09-27" @default.
- W2183241842 title "SAS ® Tools for Working with Dataset-XML files" @default.
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