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.

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.
  - Please do not submit a (local CTMS) supplemental CCSG eData report for interventional trials 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 Report:
- Cancer Centers are responsible for directly submitting their DT4 application submissions for Observational and Ancillary-Correlative studies using the OCC CCSG DT4 template https://cancercenters.cancer.gov/GrantsFunding/GrantsFunding https://cancercenters.cancer.gov/GrantsFunding/GrantsFunding.
  - Observational studies using the CTRP-generated DT4 are not yet required for Competing applications.
  - Ancillary-Correlative studies are not yet required for CTRP registration and/or CCSG Competing DT4 applications.

Templates/File Name Recommendations

File Name and Email Template 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)_FY19_01 01 18-12 31 18_Final (10 01 19).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):
- Cancer Centers to submit a CTRP-generated DT4 report(s) for Interventional and Observational trials for your Non-Competing RPPR application submission to the OCC CCSG mailbox ccsgdata@mail.nih.gov.
  - 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
    - When required, please manually add a new tab, “Supplemental – Not on Report” for trials that are not currently on your report.
  - 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.
  - Please do not submit a (local CTMS) supplemental OCC CCSG eData report for Interventional trials or Observational 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”.
Ancillary / Correlative DT4 Report:
- Cancer Centers are responsible for directly submitting their DT4 submission for Ancillary-Correlative studies to the OCC CCSG mailbox ccsgdata@mail.nih.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.
All reports (Interventional, Observational, Ancillary-Correlative) can be submitted in the same email or in separate emails based on the discretion of the Cancer Center.

Templates/File Name Recommendations

File Name and Email Template 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)_FY22_01 01 21-12 31 21_Final (01 31 22).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 FY20XX
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 << Cancer Center >>. This report reflects Fiscal Year 20XX for the reporting period January 1, 20XX – December 31, 20XX.

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

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.