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Validation checks or tools to check the compliance of SDTM data
JANUS is a standard database model which is based on the CDISC’s SDTM standard. JANUS is used by the FDA to store the submitted SDTM clinical data. As a part of data definition file submission pharmaceutical companies have to submit SAS datasets in transport file (.xpt) format along with annotated CRF and Define.xml file. The reason being this is… to properly load the clinical data into JANUS database which is maintained by the FDA. It is very easy for FDA reviewers to review the clinical data once they load the clinical data into their JANUS database. They can even produce ad-hoc reports and perform cross-study review at the same time. FDA runs compliance checks on the data submitted to make sure the data was collected as per the SDTM standard. FDA checks the compliance of data by running the WebSDM™ developed by PhaseForward). WebSDM™ is a SDTM compliance check validation tool performs a set of SDTM compliance…
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| This post was kindly contributed by StudySAS Blog - go there to comment and to read the full post. |