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DISC DTM Implementation Guide (Version 3.3)26 Domain Models Based on the General Note: This copy of the OE domain model is identical to the one that was Observation Classes made available for public.
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Morphological FAQ
A Study Data Tabulation Model Implementation Guide (SDTMIG) is developed in reference to a specific SDTM model. However, the SDTM is cumulative – each new release builds on the previous model. Therefore, the models are backward compatible. For example, SDTMIG-AP v1.
December of 2013 the CDISC world blessed us with SDTM version 3.2.
The SDTMIG for Human Clinical Trials is based on the SDTM's general framework for organizing clinical trials information that is to be submitted to regulatory authorities.
December of 2013 the CDISC world blessed us with SDTM version 3.2.
SDTMIG: The Study Data Tabulation Model Implementation Guide (SDTMIG) for human clinical trials guides users on the organization, structure, and format of standard clinical study tabulation datasets for interchange between organizations or to be submitted to a regulatory authority.
SDTMIG v3. 4 supersedes all prior versions of the SDTMIG.
The SDTM core model also supports the non-human trial standard SEND-IG. The latest versions being SDTM v2. 0 for SDTM-IG v3. 4 and SDTM-IG Medical Devices (SDTMIG-MD) v1. 1.
The first of the blocks, the Data Class, describes the datasets or domains within the SDTM. These are categorized into 6 classes; see Figure 3, which gives a description of the class, along with some examples.
Dataset Related content
Requirement Ends for Study Data Tabulation Model...
Jul 7, 2020 — Support and requirement ended for version 1.3 of the CDISC SDTM IG 3.1.3...
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