Greetings,
The changes to the Study Data Standards web page (http://www.fda.gov/ForIndustry/DataStandards/StudyDataStandards/default.htm) acknowledge CBER/CDER/CDRH-approved support for the voluntary submission of human study data using CDISC SDTM I.G. v3.1.3.
It also acknowledges our ongoing support for define.xml v.1.0.
Lonnie Smith
Policy Analyst
FDA Data Standards Council
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