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

The following documents are ready for review to the LPOs:

  • Beta CTSU Standard Forms v7.0 ALS
  • Beta CTSU Standard Forms v7.0 Release Notes
  • Beta Central study v7.0 ALS

 

The following document has been provided for the LPOs to use as a template for feedback

  • 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


The documents can be accessed at the CDISC Implementation Committee Wiki page.


March 8th, 2019:  Updated CDISC Glib ALS v1.1 to address commas in data dictionaries 

The updated CDISC Glib ALS v1.1 has been released.  The CDISC Glib ALS v1.0  released on 3/5/2019 was updated because of an error reported by an LPO while uploading the CDISC Glib ALS v1.0  in Rave.  The error was due to Data Dictionaries (DDs) in the CDISC Glib ALS v1.0 with commas in the coded data values.  CTSU analyzed the issue, and found that the 17 SDTM DDs noted below contained at least one entry with a comma.  Since this ALS will not be used for production study build activities, CTSU has removed the DD entries for these 17 DDs.  The updated CDISC Glib ALS v1.1 can now be uploaded in Rave and will display 0 entries for these 17 DDs in Rave.  As Neesha mentioned in her previous email, the LPO Rave URLs will be upgraded to Rave version 2018.2.2 by the time of the final release of the CDISC GLIB (July 2019), and uploading DDs with commas and semicolons in coded data values will not be an issue in the new version of Rave.

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