Title: SDTM mapping becomes more EASY with SAS Clinical Data Integration
Abstract: CDISC SDTM (Study Data Tabulation Model) is recommended as the standard data structure to be used for submitting tabulation data to the US FDA for clinical trials. Approach for implementing such data standards should be quick and effective with less resource utilization. SAS ® Clinical Data Integration is the solution from SAS ® which helps user to organize, standardize and manage clinical research data and metadata in compliance with CDISC SDTM or company specific internal standards. This paper will present the Graphical User Interface (GUI) approach compared to the conventional programming for SDTM mapping, performing CDISC Compliance checks and preparation of CRT-DDS define.xml which highlights the usage and unique features of SAS CDI. It also includes automation of such data integration tasks to gain speed and efficiency, different ways to check domain completion status, comparing metadata properties of domains across the studies and many more.
Publication Year: 2014
Publication Date: 2014-01-01
Language: en
Type: article
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Cited By Count: 1
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