Announcements

July 31, 2019: NCI CDISC Deliverables Release

Dear CDISC Implementation Committee Members,

NCI has completed their deliverables for the July 31, 2019 release. The files are attached and the descriptions are below.

Three CDISC GLIB documents are attached for the July 31, 2019 release.

Three CDISC CTSU Standard Forms documents are attached for the July 31, 2019 release;

Note: Issues/ questions related to the CTSU Standard Forms and CTSU integrations need to be communicated to and managed by CTSU.

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 31^st, 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 7^th, 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

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:

Merge of OPEN standard and AE standard forms
Form OIDs prefix added to include “CTSU_”
Known issues from CTEP-AERs integration ALS v2.3 is fixed in this version
Support of Central Monitoring Alert form roll out in subfolders
Conversion of forms for CDISC compliance

Variable/Field OIDs use CDASH naming convention
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
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 13^th, 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.

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 8^th, 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.

Content

Space Tools

July 31, 2019: NCI CDISC Deliverables Release

June 3rd, 2019: CDISC Project Update

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