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June 3rd, 2019:  CDISC Project Update

Dear CDISC Implementation Committee,

Release Update

Hope you all had a wonderful weekend.  Thank you to everyone who submitted comments to the GLIB and Standard Forms ALS.  The CDISC Project Team is working hard to try and incorporate as many items from your feedback into the final release.  With that, we will have a delay in our final CDISC GLIB ALS and CDISC Standard forms ALS.  The new release date will be July 31st, 2019. Please not this does not change the final compliance date at this time as we are still targeting towards January 1, 2020.  We will work to support the LPOs as much as possible to reach that date. 

Items that will be in the July 31st release include:

  • CDISC CDASHv2.0
  • SDTM v3.3
  • CDISC Terminology Package 36
  • CDISC Terminology Package 37
  • Pre-Text Updates
  • Pattern Variable Naming
  • Confirmed LPO Standard Forms AI Comments as appropriate

If you have any additional comments to the CDISC Standard Forms ALS, please submit comments no later than Friday June 7th, 2019.  After that date, comments will be reviewed and planned for the next ALS release.

 

Webinars Update

  • CDISC Webinars and Slides have now been posted to the collaboration portal
  • The CDISC Wiki is also up to do date now with corrected links fixed from wiki updates

 

CDISC SME Sessions:

  • If you need a CDISC SME Session to discuss any questions please remember to send them to the NCI CDISC Support Mailbox and we will plan for those questions in an upcoming session.

 

Thank you again for all your efforts to work together and make this CDISC compliance project move forward. 


April 1, 2019:  BETA CTSU Standard Form v7.0 Release 

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  • CDISC LPO Reviewing Template

 


The Beta CTSU Standard Forms v7.0 ALS can be uploaded by LPOs in Rave for review and impact analysis.

CTSU is continuing to test this version of the ALS for impact on our system integrations; once the testing is completed, a new version of ALS will be released that includes required CTSU integrations changes plus required changes per LPO feedback. 


The below items are included in this version of the ALS, details are provided within the Beta CTSU Standard Forms v7.0 release notes:

  1. Merge of OPEN standard and AE standard forms
  2. Form OIDs prefix added to include “CTSU_”
  3. Known issues from  CTEP-AERs integration ALS v2.3 is fixed in this version
  4. Support of Central Monitoring Alert form roll out in subfolders
  5. Conversion of forms for CDISC compliance
    1. Variable/Field OIDs use CDASH naming convention
    2. Data dictionary updates including but not limited to Country code to 3 digits(ISO 3166-1), Sex, Check box to either drop down list or radio button
    3. Query modification including removal or addition of edits and query text updates

 


Please send all questions and LPO feedback to ncicdiscsupport@nih.gov by May 13th, 2019  


NOTE: These documents will be in the CTSU Collaboration portal at Collaboration > CDMS Support Center > Integrations > General Documents > CTSU-Standard-Forms > v7.0

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