Page History

June 7, 2021:  R8 Final CTEP Standard Forms

• CTEP CDISC EQ-5D-3L (eVersion 1) v1.0
• CTEP CDISC EQ-5D-5L (eVersion 1) v1.0
• CTEP CDISC Brief Pain Inventory-BPI v1.0
• CTEP CDISC EPIC-26 Short Form (Expanded Prostate Cancer Index Composite-26) 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 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

• CTEP CDISC Physical Examination v1.0
• CTEP CDISC Follow-Up/Survival v1.0
• CTEP CDISC Lost to Follow-Up v1.0
• CTEP CDISC Eligibility v1.0
• CTEP CDISC Demography v1.0
• CTEP CDISC Medical History v1.0
• CTEP CDISC Surgery v1.0
• CTEP CDISC Vital Signs v1.0
• CTEP CDISC Concomitant Meds v1.0
• CTEP CDISC Diagnosis Intervention 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:

• 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:

• CTEP CDISC RECIST 1.1 Standard Form v1.0
• CTEP CDISC Off Treatment Standard Form v1.0
• CTEP CDISC Off Study Standard Form v1.0
• CTEP CDISC Screening Standard Form 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:

• 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.

• CTSU CDISC GLIB ALS v1.0 20190731
• CTSU CDISC GLIB ALS v1.0 Difference Report BETA-FINAL 20190731
• CTSU CDISC GLIB ALS v1.0 Release Notes FINAL 20190731

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.

• CTSU Standard Forms ALS v7.0 20190731
• CTSU Standard Forms ALS v7.0 Difference Report BETA-FINAL 20190731
• CTSU Standard Forms ALS v7.0 Release Notes FINAL 20190731

June 3rd, 2019:  CDISC Project Update

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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

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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.

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Thank you again for all your efforts to work together and make this CDISC compliance project move forward. 

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