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.
Please note that the CDISC Glib ALS v1.1, along with the release notes and NCI best practices document, has been posted to the Collaboration Portal (CDMS Support Center>Integrations>General Documents> CTSU-CDISC-Global-Library).
SDTM DDs affected:
- CVTEST
- EGTEST
- FRM
- LBTEST
- LOC
- MBTEST
- METHOD
- MITS
- MUSCTS
- OETEST
- PKPARM
- POSITION
- RETEST
- ROUTE
- SCTEST
- SPECTYPE
- TRTEST
The documents can be accessed at the CDISC Implementation Committee Wiki page.
March 7th, 2019: Rave Glib v1 Beta ALS - dictionary error, commas in coded values
We had some feedback from one of the LPOs that that they encountered a problem when uploading the CDISC Rave GLIB Beta ALS. There are multiple dictionaries that have commas or semicolons in the coded value, and Rave will not complete the ALS upload while this error stands.
We have reviewed the issue and wanted to provide some additional information:
Rave version 2018.2.2 allows comma in coded dictionary values. LPO URLs have not yet been upgraded to this version, but the CTSU BETA URL was updated to this version, and CTSU did not run into this problem during the CDISC GLIB build.
The LPO URLs will be upgraded in the next couple of months, so we do not plan to make any updates in the CDISC GLIB ALS at this point.
As a workaround, LPOs that are running on an older version of Rave can either remove the comma from data dictionary values listed in the error log, or remove the dictionaries having a comma from the ALS and upload it. Since this ALS is just for testing purposes, the LPOs can upload without these data dictionaries. We will also be sending out an updated Beta CDISC GLIB ALS without the commas tomorrow, March 8th, 2019 so that you can easily upload the ALS.
The LPO URLs should be upgraded by the time of the final release of the CDISC GLIB, so this won’t be an issue.
March 5th, 2019: Release of the NCI CDISC Rave GLIB ALS, Release Notes and Best Practices Document
The NCI has completed the development of the Beta NCI CDISC Rave Global Library ALS and sent it out to the CDISC Implementation working group on March 5, 2019. Along with the Beta NCI CDISC Rave Global Library ALS, the NCI has also sent out the set of release notes to provide support for the implementation. There is also a draft best practices document for additional support.
The scope of the release includes the following:
- CDISC CDASHv2.0
- CDISC Controlled Terminology Package 36 (2018-12-21)
- SDTM v3.3
The review period for all documents listed above is March 5th, 2019 to April 2nd, 2019. All comments, questions and feedback should be sent to ncicdiscsupport@nih.gov.
The documents can be accessed at the CDISC Implementation Committee Wiki page.
