http://www.cdisc.org/sdtm - Oct 31, 2014 10:53:55 AM - Apr 6, 2011 4:47:30 AM
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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