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Support AP 1.0 and Devices 1.0
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1
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3
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August 12, 2014
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Frequency of Use of OpenCDISC Validator
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0
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2
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May 2, 2014
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Question about variable lengths - SDTM versus ADaM
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2
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8
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April 10, 2014
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ISO 8601 :Time Hour value "24:00" or "00:00"
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2
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6
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February 10, 2014
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New FDA Guidances on Standard Data for Electronic Submissions
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0
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3
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February 7, 2014
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FDA CDER/CBER Position on Use of SI Units for Lab Tests
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0
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2
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January 16, 2014
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SDTM v1.4, SDTMIG v3.2, and SDTMIG-AP v1.0
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2
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5
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January 7, 2014
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Different SDTM 3.1.2 Rules in OC Validator 1.4.1 vs. Rules Repository
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1
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3
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October 3, 2013
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Add .sas7bdat file format as input datasets
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3
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9
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October 1, 2013
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Comment period has begun for SDTMIG v3.1.4 Draft Supplements - Batch 1
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1
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4
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August 22, 2013
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The New Jersey CDISC User’s Group is resuming its activities
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0
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2
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May 1, 2013
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Labels for Suppqual and Custom Domains in xpt files.
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3
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5
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April 5, 2013
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OpenCDISC 1.2.1 & 1.3 (FDAs Use)
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5
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8
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April 5, 2013
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OpenCDISC Validator v1.4 question
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1
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3
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April 4, 2013
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Recent FDA/PhUSE CSS event and OpenCDISC plans for quick update
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0
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2
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March 21, 2013
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Define-XML 2.0 now available for use
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0
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2
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March 16, 2013
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US FDA CDRH Updated Webpage to Cite Support of CDISC-based Submissions
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0
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3
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March 6, 2013
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FDA added SDTM 3.1.3 to the "Study Data Standards Resources" webpage
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2
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4
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February 27, 2013
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Controlling OpenCDISC using R
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0
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2
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February 25, 2013
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CDISC team updated SDTM/ADaM Pilot Project package
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0
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2
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February 1, 2013
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FDA announced the end of support for SDTM IG 3.1.1
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0
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2
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January 28, 2013
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Open CDISC Level 1 Error
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0
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0
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January 17, 2013
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OpenCDISC Validator question
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1
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0
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October 2, 2012
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The new TS dataset for submission
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1
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2
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August 15, 2012
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New version of CDISC SDTM Control Terminology is published: 2012-08-03
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0
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0
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August 13, 2012
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New FDA Study Data Specifications v2.0 document was published
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0
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2
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July 30, 2012
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SDTM v1.3 and SDTMIG v1.3.3 final documents released
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0
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4
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July 30, 2012
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define.XML
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1
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3
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May 7, 2012
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Draft SDTM V1.3 for Public Review Comments Due Monday, 2012-05-17
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0
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2
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April 21, 2012
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FDA use of Amendment 1
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1
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0
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April 5, 2012
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