NIH | National Cancer Institute | NCI Wiki  

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:


  1. CDSIC aligned question text, prompt, CDISC published CT, CDASH variables and the corresponding caDSR Form PIDs and CDE PIDs.
  2. The variables within the CTEP standard forms have a two letter domain prefix specified where appropriate as per our NCI CTEP CDISC implementation decision.
  3. 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

  1. CTEP CDISC Diagnosis Intervention v1.0
  2. CTEP CDISC Equipment v1.0
  3. CTEP CDISC Imaging Administration v1.0
  4. CTEP CDISC Consent Metastasis v1.0
  5. CTEP CDISC PET-Imaging Agent v1.0
  6. CTEP CDISC PET-Patient-Prep v1.0
  7. CTEP CDISC Progression v1.0
  8. CTEP CDISC Protocol Deviations v1.0

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:


  1. CDSIC aligned question text, prompt, CDISC published CT, CDASH variables and the corresponding caDSR Form PIDs and CDE PIDs.
  2. The variables within the CTEP standard forms have a two letter domain prefix specified where appropriate as per our NCI CTEP CDISC implementation decision.
  3. 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

  1. CTEP CDISC CTEP CDISC AE SAE CTCAEv4.0 v1.0
  2. CTEP CDISC AE SAE CTCAEv5.0 v1.0
  3. CTEP CDISC Consent v1.0
  4. CTEP CDISC Consent Withdrawal v1.0
  5. CTEP CDISC Consent Withdrawal QOL Study v1.0
  6. CTEP CDISC Consent Withdrawal Specimen v1.0
  7. CTEP CDISC Diagnosis Administrative v1.0
  8. CTEP CDISC Diagnosis Gross Pathology v1.0
  9. CTEP CDISC Enrollment v1.0
  10. CTEP CDISC Lab Test Results v1.0
  11. CTEP CDISC Prior Therapies v1.0
  12. CTEP CDISC Registration v1.0
  13. CTEP CDISC Staging AJCC Edition 8 Lung v1.0


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:


  1. CDSIC aligned question text, prompt, CDISC published CT, CDASH variables and the corresponding caDSR Form PIDs and CDE PIDs.
  2. The variables within the CTEP standard forms have a two letter domain prefix specified where appropriate as per our NCI CTEP CDISC implementation decision.
  3. 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


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 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:

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 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 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 

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.


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.


  • No labels