The Study Data Tabulation Model Implementation Guide for Human Clinical Trials (SDTMIG) Version 3.4 has been prepared by the Submissions Data Standards (SDS) team of the Clinical Data Interchange Standards Consortium (CDISC). Like its predecessors, v3.4 is intended to guide the organization, structure, and format of standard clinical trial tabulation datasets submitted to a regulatory authority. Version 3.4 supersedes all prior versions of the SDTMIG.
The SDTMIG should be used in close concert with Version 2.0 of the CDISC Study Data Tabulation Model (SDTM, available at https://www.cdisc.org/standards/foundational/sdtm), which describes the general conceptual model for representing clinical study data that is submitted to regulatory authorities and should be read prior to reading the SDTMIG. SDTMIG Version 3.4 provides specific domain models, assumptions, business rules, and examples for preparing standard tabulation datasets that are based on the SDTM.
This document is intended for companies and individuals involved in the collection, preparation, and analysis of clinical data that will be submitted to regulatory authorities.
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