- SDTMIG - CDISC
Where the SDTM provides a standard model for organizing and formatting data for human and animal studies, the SDTMIG is intended to guide the organization, structure, and format of standard clinical trial tabulation datasets
- SDTMIG v3. 4 - CDISC
SDTMIG v3 4 provides specific domain models, assumptions, business rules, and examples for preparing standard tabulation datasets that are based on the SDTM Noteworthy changes from the previous version (SDTMIG v3 3) include:
- SDTMIG v3. 3 - CDISC
This document comprises the CDISC Version 3 3 (v3 3) Study Data Tabulation Model Implementation Guide for Human Clinical Trials (SDTMIG), which has been prepared by the Submissions Data Standards (SDS) team of the Clinical Data Interchange Standards Consortium (CDISC)
- SDTMIG v3. 2 - CDISC
SDTMIG v3 2 is the implementation guide for Human Clinical Trials and corresponds with SDTM v1 4 SDTMIG v3 2 includes eleven additional domains: EC, PR, HO, DD, IS, MI, MO, RP, SR, SS, and TD All previous annotations in SDTMIG 3 1 3, published in 2012, have been incorporated in SDTMIG v3 2
- SDTMIG v3. 3 - CDISC
SDTMIG v3 3 provides the following enhancements, key additions and revisions to prior versions: Revised Disposition (DS) assumptions to facilitate greater clarity Introduction of morphology physiology domains to support specific body systems
- SDTMIG v4. 0 - CDISC
SDTMIG ADaM Analysis Results Medical Devices Tobacco IG Data Exchange ODM Define-XML Dataset-JSON Terminology Glossary Controlled Terminology Non Standard Variables Questionnaires, Ratings Scales Therapeutic Areas
- SDTM - CDISC
Download SDTM v1 3 and SDTMIG v3 1 3 IMPORTANT: Please first read the PDF document “How to Use SDTMIG 3 1 3”, which provides information of the SDTMIG 3 1 3 documentation package
- SDTMIG v3. 1. 3 - CDISC
Version 3 1 3 of the Study Data Tabulation Model Implementation Guide (SDTMIG) for Human Clinical Trials corresponds to SDTM version 1 3 Updates to the guide and the model include: Additional variables to the general observation classes for clinical and non-clinical trials
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