Study Data Tabulation Model


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Study Data Tabulation Model

In clinical trials in humans, a standardised structure to be used for data tabulations which are to be submitted as part of a product application to a regulatory authority (e.g., the FDA) and defined by The Submission Data Standards team of Clinical Data Interchange Standards Consortium (CDISC).
References in periodicals archive ?
Since the CDASH standard is harmonized with the CDISC Study Data Tabulation Model (SDTM), the content standard for regulatory submission of case report form tabulations referenced in FDA e-Submission Guidance, use of CDASH v 1.
The WebSDM product checks data for conformance with the Clinical Data Interchange Standards Consortium (CDISC) Study Data Tabulation Model (SDTM), creating a data repository that is then available for review and reporting purposes.
The Study Data Tabulation Model (SDTM) data standard was developed by the Clinical Data Interchange Standards Consortium (CDISC).
The system is also integrated with the company's WebSDM[TM] (Web Submission Data Manager) platform to offer seamless support for the Clinical Data Interchange Standards Consortium (CDISC) Study Data Tabulation Model (SDTM) data standard.
Woodcock added that "the FDA has now adopted the CDISC Study Data Tabulation Model (SDTM) for electronic submissions.
Incorporation of the CDISC Study Data Tabulation Model (SDTM) and Laboratory Standards Team (LAB) with its Clintrial clinical data management solution including a tool within Lab Loader for mapping LAB files into SDTM;

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