http://www.cdisc.org/sdtm - Nov 27, 2014 1:51:20 AM - Apr 6, 2011 4:47:30 AM
New Draft SDTMIG Version 3.3 Batch 2 Now Available for Public Review – Comments due December 10, 2014
Batch 2 of the draft CDISC Study Data Tabulation Model Implementation Guide (IG) Version 3.3 is now available for public comment. For detailed information on the contents of this batch, please read the “Batch 2 Introduction Document” first. Batch 2 contains 3 new domains, a new Disease Milestones modeling approach previously applied in the Diabetes TA User Guide, and additional information on using Intervention domains and representation of Supplemental Qualifiers in a parent domain. To aid reviewers, an informal rolling draft copy of version 1.5 of the Study Data Tabulation Model is included for reference and context only. This rolling draft displays proposed changes from from v1.4, incorporating additional variables and sections to support these new features as well as new features in SENDIG v3.1. The formal draft of SDTM v1.5 will be issued for public comment in a future release.
Please access the document package and provide comments through the CDISC Public Comment Tracker tool.
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Comments due 04 December
Pharmacogenomics/Genetics Version 1.0 - Now Available for Public Review - Comments due December 2, 2014
New Draft Standard Study Data Tabulation Model Implementation Guide:
Pharmacogenomics/Genetics Version 1.0 -- Now Available for Public Review – Comments due December 2, 2014
The CDISC Draft Study Data Tabulation Model Implementation Guide: Pharmacogenomics/Genetics (SDTM-PGx) v1.0 is now available for a 45-day public review. The aim of this new proposed standard is to guide the representation in SDTM format of gene-related data (including data relevant to biospecimen handling, genetic variation, gene expression and biomarkers) submitted to regulatory authorities as part of a product application.
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Please submit your comments using the CDISC Public Comment Tracker on the CDISC Portal for this review.
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Detailed information on using the tracker can also be found via “Help” after clicking on Public Comment Tracker.