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June 7, 2021: R8 Final CTEP Standard Forms

These CTEP standard forms have been created as part of the NCI CTEP CDISC Implementation. This is a collaborative effort between NCI CBIIT and NCI CTEP; the NCI CDISC aligned content has been leveraged as appropriate in consideration of NCI CTEP CDISC implementation. The CTEP standard forms include:

CDSIC aligned question text, prompt, CDISC published CT, CDASH variables and the corresponding caDSR Form PIDs and CDE PIDs.
The variables within the CTEP standard forms have a two letter domain prefix specified where appropriate as per our NCI CTEP CDISC implementation decision.
The NCTN/ETCTN curation style guide requirements have been applied to the content in the CTEP standard forms.

We are actively working on R6 and R7. An update will be provided as available. If you have any questions, please send an email to ncicdiscsupport@nih.gov.

March 29th, 2021: CTEP Standard Form Release for R5

R5 Final CTEP Standard Forms

CDSIC aligned question text, prompt, CDISC published CT, CDASH variables and the corresponding caDSR Form PIDs and CDE PIDs.
The variables within the CTEP standard forms have a two letter domain prefix specified where appropriate as per our NCI CTEP CDISC implementation decision.
The NCTN/ETCTN curation style guide requirements have been applied to the content in the CTEP standard forms.

We are actively working on R6. An update will be provided as available. If you have any questions, please send an email to ncicdiscsupport@nih.gov.

A thank you to CBIIT for their collaboration and support efforts on this project. A thank you to all of our LPOs for all your engagement to make this implementation a success.

January 27th, 2021: CTEP Standard Form Release for R4

R4 Final CTEP Standard Forms

CDSIC aligned question text, prompt, CDISC published CT, CDASH variables and the corresponding caDSR Form PIDs and CDE PIDs.
The variables within the CTEP standard forms have a two letter domain prefix specified where appropriate as per our NCI CTEP CDISC implementation decision.
The NCTN/ETCTN curation style guide requirements have been applied to the content in the CTEP standard forms.

We are actively working on R5. An update will be provided as available. If you have any questions, please send an email to ncicdiscsupport@nih.gov.

November 2nd, 2020

Based on feedback from the LPOs and the CDISC project team, we have determined that the TRIAD forms in R2 are administrative. We do not have an active use case to align any of the content. Using the same rule we have for all forms, if there is a use case identified we will revisit the roadmap and align the needed content.

October 30th, 2020: CTEP Standard Form Release for R3

R3 Final CTEP Standard Forms

CDSIC aligned question text, prompt, CDISC published CT, CDASH variables and the corresponding caDSR Form PIDs and CDE PIDs.
The variables within the CTEP standard forms have a two letter domain prefix specified where appropriate as per our NCI CTEP CDISC implementation decision.
The NCTN/ETCTN curation style guide requirements have been applied to the content in the CTEP standard forms.

We are actively working R4. An update will be provided as available. If you have any questions, please send an email to ncicdiscsupport@nih.gov.

October 2nd, 2020: CTEP Standard Form Release for R1

Please find attached the CTEP CDISC Standard Forms for Round 1 per our roadmap. The CTEP CDISC Standard Forms for R1 are:

CDSIC aligned question text, prompt, CDISC published CT, CDASH variables and the corresponding caDSR Form PIDs and CDE PIDs.
The variables within the CTEP standard forms have a two letter domain prefix specified where appropriate as per our NCI CTEP CDISC implementation decision.
The NCTN/ETCTN curation style guide requirements have been applied to the content in the CTEP standard forms.

We are actively working R3. An update will be provided as available. If you have any questions, please send an email to ncicdiscsupport@nih.gov.

A thank you to CBIIT for their collaboration and support efforts on this project. A thank you to all of our LPOs for all your engagement to make this implementation a success and a thank you to Shannon for all your CDISC support.

New Deliverable Date for CDISC Implementation

All CTEP IND Studies activated on or after March 1, 2020 shall be CDISC compliant (submit to FDA in SDTM Format).

Studies activated prior to February 28th, 2020 do NOT need to be CDASH compliant but LPOs are encouraged to launch CDASH compliant studies prior to the March 1st deadline, if possible.
- Waivers will only be considered by the NCI for truly extenuating circumstances that meet both of the following criteria
  - The justification is for something beyond LPO control
  - AND the activation date was anticipated to be prior to January 1, 2020

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

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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:

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

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