News

“SUMMARY: The Center for Biologics Evaluation and Research (CBER), the Center for Drug Evaluation and Research (CDER), and the Center for Devices and Radiological Health (CDRH) are announcing the end of support for the 3.1.1. version of Clinical Data Interchange Standards Consortium (CDISC) Study Data Tabulation Model (SDTM) Implementation Guide (SDTM IG 3.1.1.). SDTM IG 3.1.2, which has been available since October 2009, is the newer standard supported by FDA. Support for SDTM IG 3.1.1 will end on January 28, 2015.”

New version of CDISC SDTM Control Terminology is published: 2012-08-03

http://evs.nci.nih.gov/ftp1/CDISC/SDTM/

The previous version was 2012-06-29

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

http://www.fda.gov/downloads/ForIndustry/DataStandards/StudyDataStandards/UCM312964.pdf

http://www.cdisc.org/sdtm

 

Not just new variables, but also Oncology TA (tumor and responses) domains. Hit up the link: http://www.cdisc.org/sdtm

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

2011 Assessment of CDER’s Data Standards Program 2012-01-12 http://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/FormsSubmissionRequirements/ElectronicSubmissions/UCM287409.pdf

Guidance for Industry Providing Regulatory Submissions in Electronic Format — Standardized Study Data Draft Guidance, 2012-02 http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM292334.pdf