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News
Description
Latest news about data validation, CDISC standards, and regulatory compliance
April 21, 2012
Not just new variables, but also Oncology TA (tumor and responses) domains. Hit up the link: http://www.cdisc.org/sdtm
March 27, 2012
During Computational Science Symposium (Silver Spring, MD, USA, March 19-20, 2012) the FDA and PhUSE launched several working groups. One of them is dedicated to Data Validation and Quality Assessment. See details on PhUSE website and its wiki page.
http://www.phuse.eu/css
http://www.phusewiki.org/wiki/index.php?title=Data_Validation_and_Quality_Assessment
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March 9, 2012
2011 Assessment of CDER’s Data Standards Program
2012-01-12
http://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/FormsSubmissionRequirements/ElectronicSubmissions/UCM287409.pdf
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March 9, 2012
Guidance for Industry Providing Regulatory Submissions in Electronic Format — Standardized Study Data Draft Guidance, 2012-02 http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM292334.pdf
