4 Radnor Corporate Center
Suite 350
Radnor, PA 19087
+1 (888) 507-2270
News
Description
Latest news about data validation, CDISC standards, and regulatory compliance
August 5, 2012
At on-line commenting: http://cdiscportal.digitalinfuzion.com/CT/Review%20Documents/Forms/AllItems.aspx
Details: http://www.cdisc.org/sdtm
P.S. Credit: Lex Jensen and his tweets
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
Read More
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
Read More
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Guidance for Industry Providing Regulatory Submissions in Electronic Format — Standardized Study Data Draft Guidance, 2012-02 http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM292334.pdf
