NIH | National Cancer Institute | NCI Wiki  

Error rendering macro 'rw-search'

null

Versions Compared

Old Version 1

changes.mady.by.user Warmington, Christina (NIH/NCI) [C]

Saved on

compared with

New Version 2

changes.mady.by.user Warmington, Christina (NIH/NCI) [C]

Saved on

Key

  • This line was added.
  • This line was removed.
  • Formatting was changed.

...

The expectation is that each Designated Cancer Center will maintain their data within CTRP throughout the year.  For any questions/concerns, please reach out to the CTRO (NCICTRO@mail.nih.gov) and/or any other Cancer Centers as early in the process as possible.

Non-Competing Submissions

Submissions Requirements

CCSG Competing Type 2/Renewal Applications

CTRP-generated DT4 (PDF) version:  Used for CCSG Competing Type 2/Renewal applications (limited fields in support of the Competing Data Guide requirements for DT4) https://cancercenters.cancer.gov/GrantsFunding/DataGuide 

  • Required:  Interventional trials only 
  • “Download” - File Type “PDF” report export option 
  • Read only; Comments are NOT acceptable 
  • Submission Process:  Cancer Center uploads CTRP-generated DT4 (PDF) to the eRA Commons/ASSIST system 

Submissions Requirements

  • Interventional Trials DT4 Report:
    • Cancer Center uploads CTRP-generated DT4 (PDF) to the eRA Commons/ ASSIST system.  Refer to the detailed instructions for submitting Competing DT4 applications as published by the OCC.
      • Ideally a PDF read-only generated version directly from the CTRP-generated DT4 system (STRAP), rather than a PDF of the Excel version.
      • Read only; Comments are NOT acceptable. Any additional critical comments should be highlighted in the Narrative
    Interventional and/or Observational DT4 Report(s):
    • Cancer Centers to submit a CTRP DT4 report(s) for Interventional and Observational trials for their non-competing submission to the Office of Cancer Centers (OCC) CCSG mailbox ccsgdata@mail.nih.gov.
      • The PDF CTRP DT4 Report is not required for non-competing submission
      • Excel version of your CTRP DT4: Please do not overwrite the data in the main report fields (columns A-AB) as this data has to remain static representing the data in CTRP on that specific date. You can add comments in column AC as well as on a “Supplemental – Not on Report” tab.
      • If you include any comments/annotations (column AC only) on your final CTRP-generated DT4 report for interventional and/or Observational trials, please keep high-level and factual. For example: Column abbreviation name and the data value from your local CTMS:
      • Reached out to Lead Org to update our data.
        • Ctr to Date = x, Ctr Rpt Period = x, Oth to Date = x, Oth Rpt Period = x.
      • Please do not submit a (local CTMS) supplemental OCC CCSG eData report for interventional or Observational trials https://cancercenters.cancer.gov/GrantsFunding/eData#dt4 to to the NCI OCC CCSG mailbox. If you do, they will not accept this supplemental version and will refer to the CTRP DT4 for interventional trials (PDF) as the “authoritative source”.
      • Please work internally with your Cancer Center Administration to better understand your Cancer Center specific review and submission process.
  • Observational and Ancillary / Correlative DT4 Ancillary / Correlative DT4 Report:
    • Cancer Centers are responsible for directly submitting their DT4 submission for Ancillary / Correlative trials to  application submissions for Observational and Ancillary-Correlative studies using the OCC CCSG mailbox ccsgdata@mail.nih.gov. The NCI CCCT/CTRP team is not involved in supporting the DT4 submission process for these trials.
    Note: All reports (Interventional, Observational, Ancillary/Correlative) can be submitted in the same email.  The CTRP Generated Interventional and Observational DT4 Report can be downloaded together or in separate reports.

Templates/File Name Recommendations

...

    • CTRP DT4 report(s) file-naming suggestion; e.g., to be customized to actual dates; such as 10 01 19):
      • Cancer Center_DT4 (INT)_FY19FY19_01 01 18-12 31 18_Final (10 01 19).xlsx
      Center to customize the below email template based on your center-specific needs
      • pdf
        << PDF read-only version from the CTRP DT4 reporting tool; not a PDF of the Excel with comments>>
    • Below “To” email is the NCI OCC CCSG ccsgdata@mail.nih.gov mailbox which is managed directly by the NCI OCC team
      • Please cc your NCI OCC Program Director if you have this information (optional).
      • Flag “Request Read Receipt” (for confirmation purposes)

...

CCSG Non-Competing RPPR Applications

  • CTRP-generated DT4 (Excel) version:  Used for CCSG Non-Competing Research Performance Progress Reports (RPPR) applications (fields in support of the Non-Competing eData Guide requirements for DT4) https://cancercenters.cancer.gov/GrantsFunding/eData   
    • Required:  Interventional trials and Observational studies only 
    • “Download” - File Type “XLSX” (Excel) report export option 
    • Comments (Column AC in the report) are acceptable 
    • Submission Process:  Cancer Center emails CTRP-generated DT4 (Excel) to the OCC CCSG mailbox ccsgdata@mail.nih.gov

Submissions Requirements

  • Interventional and/or Observational DT4 Report(s)

...

This email, including attachments, may contain privileged and confidential information intended only for the use of the individual(s) named above. Dissemination, distribution, or copying of this message or its contents is subject to authorization by the sender. If you have received this message in error, please notify the sender and delete immediately.

Type 2 / Renewal (Competing) Submissions

Submissions Requirements

  • Interventional DT4 Report:
    • Cancer Centers to submit a CTRP-generated DT4 report(s) for Interventional and Observational trials for their competing submission to the Office of Cancer Centers (OCC) CCSG mailbox  your Non-Competing RPPR application submission to the OCC CCSG mailbox ccsgdata@mail.nih.gov.
      • PDF read-only generated version directly from the CTRP DT4 system, not a PDF of the Excel version with updates/comments.
      • Excel version of your CTRP-generated DT4:
        • Do not overwrite the data in the main report fields (columns A-AB) as this data must remain a static representing the data in CTRP on that specific date.
        • You can add comments/annotations in column AC as well as on a center-added, “Supplemental – Not on Report” tab.
      • If you include any comments/annotations (column AC only) on your final CTRP-generated DT4 report for Interventional and/or Observational studies, please keep high-level and factual.
        • For example: Column abbreviation name and the data value from your local CTMS:
          • Reached out to Lead Org to update our data.
          • Ctr to Date = x, Ctr Rpt Period = x, Oth to Date = x, Oth Rpt Period = x
        Any additional comments required for your OCC Program Director should be highlighted in the Cancer Center Narrative
          • .
      • Please do not submit a (local CTMS) supplemental OCC CCSG eData report for interventional  Interventional trials or Observational trials https://cancercenters.cancer.gov/GrantsFunding/eData#dt4 to the NCI  studies to the OCC CCSG mailbox. If you do, they will not accept this supplemental version and will refer to the CTRP DT4 for interventional trials and observational studies as the “authoritative source”.
  • Observational and Ancillary / Correlative DT4 Correlative DT4 Report:
    • Cancer Centers are responsible for directly submitting their DT4 submission for Observational and Ancillary / -Correlative trials  studies to the OCC CCSG mailbox mailbox ccsgdata@mail.nih.gov for NCI's FY2022.
    • Observational studies are not yet required for competing submissions.
    • .gov using the CCSG template https://cancercenters.cancer.gov/GrantsFunding/GrantsFunding.
    • The NCI CCCT/CTRP team is not involved in supporting the DT4 submission process for these studies.
  • Note: The CTRP-generated Interventional and Observational DT4 Report(s) can be downloaded together or in separate DT4 reports.
  • Note: All reports (Interventional, Observational, Ancillary/-Correlative) can be submitted in the same email.  The CTRP Generated Interventional and Observational DT4 Report can be downloaded together or in separate reportsemails based on the discretion of the Cancer Center.

Templates/File Name Recommendations

...

    • CTRP DT4 report(s) file-naming suggestion; e.g., to be customized to actual dates; such as 10 01 19):
      • Cancer Center_DT4 (INT)_FY19FY22_01 01 1821-12 31 1821_Final (10 01 1931 22).pdf
        << PDF read-only version from the CTRP DT4 reporting tool; not a PDF of the Excel with comments>>xlsx
    • Center to customize the below email template based on your center-specific needs
      • Below “To” email is the NCI OCC CCSG ccsgdata@mail.nih.gov mailbox which is managed directly by the NCI OCC team
      • Please cc your NCI OCC Program Director if you have this information (optional).
      • Flag “Request Read Receipt” (for confirmation purposes)

...

~-~-~-**EMAIL TEMPLATE TO BE CUSTOMIZED AND SENT BY CANCER CENTER**~-~-~-~
From: << Cancer Center >>
To: ccsgdata@mail.nih.gov
Cc: Cancer Center Administrator; Cancer Center Staff; NCIOCC Program Director (optional)

Subject: Cancer Center: Final DT4 Report FY2021XX
Importance: High

Dear National Cancer Institute Office of Cancer Centers:

I am submitting the final CTRP-generated Data Table 4 (DT4) report for interventional trials and observational studies on behalf of the “x”  << Cancer Center >>. This report reflects Fiscal Year 20XX for the reporting period January 1, 2018 – 20XX – December 31, 201820XX.

This email includes a copy of the following documents for review:
• Final << Cancer Center >> CTRP-Generated DT4 Report(s) (Interventional Trials and Observational Trials Studies) Report  with comments (Excel Version “supporting version with comments” and/or “Supplemental – Not on Report” tab)
• Local Center Version of Ancillary / Correlative trials Final << Cancer Center >> CCSG DT4 (Ancillary-Correlative studies) (using the CCSG DT4 template)

Do not hesitate to contact us if you have any immediate questions.

Regards,
From: << Cancer Center >>

...