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CRT DDS -Define.xml File

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CRT DDS -Define.xml File

Post  falguni.mathther on Wed May 16, 2012 5:33 pm

For data Accuracy, submission of clinical study data demanded to be electronic by FDA. This submission includes information of clinical data and also the information to understand that data. As a solution of electronic submission CRT DDS (Case Report Tabulation Data Definition Specification)-define.xml was prepared by CDISC define.xml team.
To increase the level of automation and improve the efficacy of regulatory review process define.xml file can be used to provide data definition file in machine readable format.
All xml files can be read easily with SAS and can be converted into SAS dataset for further data validation check.
ref :http://www.cdisc.org/define-xml


falguni.mathther

Posts : 5
Join date : 2012-03-26

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