Submission data tabulation model

Name="Submissions Data Tabulation Model Version 3.1 - Trial Meta Version... 

Both approaches to study day calculation are used in the pharmaceutical industry, although the algorithm in Program 4.3 is probably used more often. The CDISC Submission Data Tabulation Model states that you should use the algorithm in... 

Case Report Tabulation Data Definition Specification (Define.xml). Define.xml is the upcoming replacement for the data definition file (define.pdf) sent to the FDA with electronic submissions. Define.xml is based on the CDISC ODM model and is intended to provide a machine-readable version of define.pdf. Because define.xml is machine readable, the metadata about the submission data sets can be easily read by computer applications. This allows the FDA to work more easily with the data submitted to it. 

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