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Paper Abstract
SAS support for Clinical Data Standards can be fully realized with the SAS Clinical Standard Toolkit (CST) version 1.2. This is bundle with Base and has the features for validating SDTM and creating DEFINE.XML documentation. The initial effort from SAS was to develop PROC CDISC but this has been halted and all future development will now support CST. This paper will present a step by step tutorial on the configuration and use of CST with SAS 9.2. Some highlights include:
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Installation and Configuration – Additional configuration of the software after SAS installation is required.
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Data Preparations – In order for CST to be used effectively with your clinical data, SAS data and its metadata will need to be setup.
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SDTM Validation– A validation of your CDISC data will be performed against SDTM 3.1.1.
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Scripting Process – The toolkit is designed as a scripting programming tool. This will walk you through the syntax so it can be applied to large sets of data efficiently.
CDISC SDTM is currently used as guidelines for standard data used in electronic submission. It will soon be updated to become a regulation so all future studies needs to be transformed to this structure. The validation and documentation will play a pivotal role in the success of any submission. This tutorial will provide the essential steps towards accomplishing this goal.
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