What is CDisc SDTM?

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What is CDisc SDTM?

A. Sudy Data Tabulation Model deals with Standardization of Research Data.

Study Data Tabulation Model Implementation Guide for Human Clinical Trials (SDTMIG) which prepared by the Submissions Data Standards (SDS) team of the Clinical Data Interchange Standards Consortium (CDISC), to guide the organization, structure, and format of standard clinical trial tabulation datasets submitted to a regulatory authority  (FDA).

Standardized datasets  helps in:-

1. To store  all submitted data  in a repository and
2. With the use of standard software tools, help to work with the data more effectively  with less preparation time and better support viewing and analysis.
3. Facilitate data interchange between partners and providers.

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