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The data elements in the Data Table 4 report generated from CTRP closely align with that of the P30 Cancer Center Support Grant (CCSG). For information on the CCSG Data Table 4 report, refer to https://cancercenters.cancer.gov/GrantsFunding/eDataeData#dt4. The following tables describe the data elements displayed in the CTRP Data Table 4 report, and demonstrate this alignment of data elements with the CCSG report. (For element descriptions, also refer to CTRP Dictionary.) 

The following table describes the elements that appear in the CTRP report header, indicating the contents of the report. For instructions on configuring the report, refer to Generating the CTRP Data Table 4 Report.

CTRP Data Table 4 reporting for interventional trials (non-competing CCSG applications) started in FY18 (after October 1, 2017).   NCI transitioned to CTRP DT4 for interventional trials for competing CCSG applications in FY20 (started May 25, 2020 submissions). 

CTRP Data Element

Description of CTRP Data Element

CCSG Column Name

Cancer Center Organizational Family 

(Cancer Center Family already setup in CTRP which appears in CTRP Data Table report drop-down for your center) 

CTRP Organization Family Name. The name of the CTRP organization family as defined by the Cancer Center.   The CTRP Data Table 4 report uses the CTRP Family-Organization relationships to select trials for a report.  Reports are based on a Cancer Center Family.  All trials for which the Family organizations or affiliates are participating sites are included in the report.

Organizations and Affiliates can only be assigned formally to one designated Cancer Center at a time. 

(No column)

(CTRP Data Table 4 report title)  

Cancer Center Organizational Family (Organizations) 

(Cancer Center Family already setup in CTRP)  

Trials associated with a Cancer Center’s Organization(s) (e.g., your Cancer Center and its formal Consortium Partners)   are reported in the “Center Reporting Period” and “Center To Date” accrual columns.  

(No column)

(CTRP Data Table 4 report title)  

Cancer Center Organizational Family (Affiliations) 

(Cancer Center Family already setup in CTRP)  

Trials associated with a Cancer Center’s Affiliation(s), i.e. trials at hospitals, treatment facilities, and/or research facilities that are associated with but not a formal part of the Cancer Center (e.g., nearby community hospitals) are reported in the “Other Reporting Period” and “Other To Date” accrual columns.  

(No column)

(CTRP Data Table 4 report title) 

Reporting Period Start Date
(CTRP Data Table 4 selection criteria) 

The date Date you have specified as the start date for the reporting period.

ReportingStartDate

(CTRP Data Table 4 report title) 

Reporting Period End Date

(CTRP Data Table 4 selection criteria) 

The date Date you have specified as the end date for the reporting period.

ReportingEndDate

(CTRP Data Table 4 report title)  

Trial Type Indicator

(CTRP Data Table 4 selection criteria) 

An indication Indicates whether the report includes data from a specific trial type or all trial types. For information, refer to Trial Types and Subtypes.

  • All
  • Interventional
  • Non-interventional

(No column)

( CTRP Data Table 4 report title)  

Fiscal Year

(CTRP Data Table 4 selection criteria) 

The annual Annual period you have specified for the report . It can be from October 1 of the prior year through September 30 of the year being described (such as fiscal year 2014).

FY

(e.g., FY 2018 January 1, 2017-December 31, 2017).   

FY

(CTRP Data Table 4 report title) 

 

Scope of Trials on the Report

For a trial to be included on a Cancer Center’s CTRP Data Table 4 report, the trial must be “Open” at both the Overall Trial-level and at the Participating Site-level for the selected reporting period.  CTRP DT4 logic looks at the first Open and first Closed recruitment statuses for the Overall Trial and the Site when deciding which trials to include on a report.

Open statuses include the following:

  • Active
  • Available
  • Enrolling by Invitation
  • Temporarily Closed to Accrual
  • Temporarily Closed to Accrual and Intervention
  • Temporarily Not Available

The following table describes the elements that appear in the CTRP report as columns.

The report displays the last name, first name, and middle initial of the PI for the trial or participating site, as follows:

  • If a member of the specified Cancer Center Family is the lead organization of the trial, the report displays the name of the PI for the trial.
  • Otherwise, the report displays the name of the PI for a participating site, as follows:
  • If only one member of the specified Cancer Center Family is a participating site on the trial, the report displays the name of the PI for that site.
    • Otherwise, the report displays the name of the PI for the first participating site with the Organizational affiliation (the first one added to the trial).
CTRP Data ElementDescription of CTRP Data ElementCCSG Column Name

P30 Grant Number

The Cancer Center Support Grant number.

Info

This is the P30 Grant Serial number (such as CAxxxxxx). This is NOT the grant associated with the lead organization of the trial.

GrantNumber

Clinical Research CatResearch Category

The trial typeClinical Research Category. The 

Include Page
Trial Attribute Trial Type - Include v4.4
Trial Attribute Trial Type - Include v4.4
For information, refer to Trial Types and Subtypes. The report uses the following abbreviations:

  • INT = Interventional trial 

Note:  Expanded Access studies are currently listed in CTRP under the Interventional trial category.

  • OBS = Observational, non-interventional trial
  • ANC/COR = Ancillary/Correlative non-interventional trial
ClinicalResearchCat

Study Source

The

Include Page
Trial Attribute Study Source DT4 Funding - Include v4.4
Trial Attribute Study Source DT4 Funding - Include v4.4
For information, refer to CTRP Trial Categories, Study Sources. The report uses the following abbreviations:

  • N = National
  • E = Externally Peer-Reviewed
  • I = Institutional
  • D = Industrial 

Trials that are imported as Industrial/Other such as Consortia trials are included in the source category as N, E, I. The Study Source column indicates only the content of the trial, not how the trial is entered.

StudySource

Specific Funding Source

The

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Trial Attribute DT4 Funding Sponsor Org - Include v4.4
Trial Attribute DT4 Funding Sponsor Org - Include v4.4
 

FundingSource

Primary Site

Include Page
Trial Attribute Anatomic Sites - Include v4.4
Trial Attribute Anatomic Sites - Include v4.4

For a list of values, refer to Data Table 4 Anatomic Site Values.

PrimarySite
NCT ID

The

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Trial Attribute NCT ID - Include v4.4
Trial Attribute NCT ID - Include v4.4

NCTID
NCI ID

The

Include Page
Trial Attribute NCI ID - Include v4.4
Trial Attribute NCI ID - Include v4.4

NCTNumberNCIID

Protocol ID

Lead Org The lead organization trial ID. The

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Trial Attribute Lead Org Trial ID - Include v4.4
Trial Attribute Lead Org Trial ID - Include v4.4

ProtocolID
Other Protocol IDs 

Additional IDs assigned to the trial, including the following:

  • NCI
  • CTEP or DCP
  • Unique IDs from other registries
  • NIH grant numbers
  • Protocol numbers assigned by the review board
  • Other IDs
(No column)OthProtocolID
Local Trial IDThe unique ID assigned at the Cancer Center level and used at the sites level to identify a trial. (No column)

Is Multi Institutional?

Indicates whether there is more than one Cancer Center participating in the trial, as follows:

  • Y (Yes) = There is more than one Cancer Center participating in the trial.
  • N (No) = There is only one Cancer Center participating in the trial.
MultiInst?
For instructions on specifying this information in CTRP, refer to Managing Local Trial IDs.  Note:  Identifier that the Cancer Center has provided which helps them to map the trial from their local CTMS to CTRP.  LocalTrialID

Is Multi Institutional?

Include Page
DT4 Multi Institutional - Include 20180214
DT4 Multi Institutional - Include 20180214

IsMultiInst

PI (Principal Investigator) - Last Name, First Name, MIMiddle Initial

The PI fields on the CTRP-generated DT4 report include the Last Name, First Name and Middle Initial of the PI from the Center who is responsible for the Clinical Research Study.
  • If a Site Administrator has specified a Center Principal Investigator in CTRP, the CTRP-generated DT4 report displays that name. For instructions on specifying this information in CTRP, refer to Specifying the Center Principal Investigator.
  • If no Center Principal Investigator is specified in CTRP, this field is blank/null on the CTRP-generated DT4 report
Include Page
Trial Attribute PI - Include v4.4Trial Attribute PI - Include v4.4


LastName, FirstName, MiddleName

Prog Program Code

The Program Code.

Include Page
Trial Attribute Program Code - Include v4.4
Trial Attribute Program Code - Include v4.4
Multiple program codes are separated with semicolons. For instructions on specifying this information in CTRP, refer to Managing Program Codes.

ProgCode

Open Date

Date on which the trial status became Active. When you generate the report, the system considers:

  • The overall trial status, rather than the status of the participating site on the trial.
  • Whether this date occurred within the date range you specify.

For details, refer to Types of Trials Included in the CTRP Data Table 4 Report.

OpenDate

Close Date

Date on which the trial status became either of the following statuses:

  • Closed to Accrual
  • Closed to Accrual and Intervention

When you generate the report, the system considers:

  • The overall trial status, rather than the status of the participating site on the trial.
  • Whether this date occurred within the date range you specify.

For details, refer to Types of Trials Included in the CTRP Data Table 4 Report.

CloseDate

The official start date of a trial at your Center determined by 1) the date of activation noted in an official clinical trial activation announcement or 2) date of first patient accrual if the trial in question did not have a formal activation announcement.   This value on CTRP DT4 is determined by the earliest “open” status date at any site associated with the center on the trial.The following trial statuses reflect an “open” status in CTRP:  Active, Enrolling by Invitation, Available, Temporarily Closed to Accrual or Temporarily Closed to Accrual and Intervention, Temporarily Not Available.

OpenDate

Close Date

The date the clinical research study closed to accrual. This does not include patient follow-up. If the study is still open at any site associated with the family, this field will be blank/null on the CTRP-generated DT4 report.  This value on the CTRP-generated DT4 is determined by the latest first “closed” date at any site associated with the cancer center on the trial.  The following statuses reflect a “closed” status in CTRP: Closed to Accrual, Closed to Accrual and Intervention, Complete, Administratively Complete or Withdrawn, No longer Available, Approved for Marketing.

CloseDate

Phase

Phase

The

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Trial Attribute Phase - Include v4.4
Trial Attribute Phase - Include v4.4
For details, refer to Trial Phase Value Definitions.

Phase
Pilot

An indication Indicates

Include Page
Trial Attribute Pilot - Include v4.4
Trial Attribute Pilot - Include v4.4

(No column)IsPilot

Primary Purpose

The

Include Page
Trial Attribute Primary Purpose - Include v4.4
Trial Attribute Primary Purpose - Include v4.4
The report uses the following abbreviations:

  • Tre = Treatment
  • Pre = Prevention
  • Sup = Supportive Care
  • Scr = Screening
  • Dia = Diagnostic
  • Hsr = Health Services Research
  • Bas = Basic Science
  • Dev = Device Feasibility
  • Oth = Other

For more information about these values, refer to Primary Purpose Value Definitions. For instructions on specifying the primary purpose for a trial, refer to Recording Trial Details.

PrimaryPurpose

Official Title

The

Include Page
Trial Attribute Official Title - Include v4.4
Trial Attribute Official Title - Include v4.4

OfficialTitle
Entire StudyAnticipated The anticipated (target) number of subjects (accrual) for the entire trial if the specified Cancer Center is the lead organization. A blank field indicates that the specified Cancer Center is not the lead organization.EntireStudy
Your Center Total

The participating site (Cancer Center) target accrual. The system displays this value if available in CTRP for the trial. For instructions on specifying this information in CTRP, refer to Managing Targeted Accrual. However, the value should be reported in this column if it is at all available, whether in CTRP or otherwise.

YourCenterTotal
Center Reporting Period

Total The total number of subjects accrued for the trial for all organizations in the Cancer Center Family with the relationship “Organization” for the time period you selected.

  • If detailed accrual information was reported for the trial, the system calculates accrual within the specified time period (such as 12 months) based on the Subject Registration Date.
  • If summary accrual was reported (such as for Industrial trials), the system calculates accrual for a selected time period as follows: 
    • If a cut-off date is available, the system calculates accrual based on the cut-off date.
    • If a cut-off date is not available, the system uses the accrual registration date as the cut-off date.

The system calculates accrual for a selected time period based on the difference between the last summary accrual reported before the time period and the last summary accrual reported within the time period. If no summary accrual was reported before the time period selected, the system displays the last summary accrual reported within the time period as the accrual count for the time period.

For an example, refer to CTRP Data Table 4 Report Accrual Calculation.

Center12Mos
Center to Date

Total The total number of subjects accrued to date (as of the selected time period end date) for the trial for all organizations in the Cancer Center Family with the relationship “Organization”.

For an example, refer to CTRP Data Table 4 Report Accrual Calculation.

CenterToDate
Other Reporting Period

Total The total number of subjects accrued for the trial for all organizations in the Cancer Center Family with the relationship “Affiliation” for the time period you selected.

  • If detailed accrual information was reported for the trial, the system calculates accrual within the specified time period (such as 12 months) based on the Subject Registration Date.
  • If summary accrual was reported (such as for Industrial trials), the system calculates accrual for a selected time period as follows: 
    • If a cut-off date is available, the system calculates accrual based on the cut-off date.
    • If a cut-off date is not available, the system uses the accrual registration date as the cut-off date.

The system calculates accrual for a selected time period based on the difference between the last summary accrual reported before the time period and the last summary accrual reported within the time period. If no summary accrual was reported before the time period selected, the system displays the last summary accrual reported within the time period as the accrual count for the time period.

Other12Mos
Other to Date

Total The total number of subjects accrued to date (as of the selected time period end date) for the trial for all organizations in the Cancer Center Family with the relationship “Affiliation”.

OtherToDate
Entire Study Accrual To Date
  • If the Lead Organization, column is populated with a summary of accrual for all participating sites on the trial through the last day of the reporting period (directly and not directly connected to the Lead Organization CTRP Family).
  • If a Participating Site, column is blank.
Entire Study Accrual To Date
CommentsComments

In the CTRP reporting application, this column is intentionally blank. To use this column:

  1. Export the report to comma-separated valuesMicrosoft Excel. For instructions, refer to Working with CTRP Automated Reports.Open the exported file in a spreadsheet application.
  2. In the spreadsheet, add comments to this column. (NCI recommends up to 50 characters.)
  3. Print the spreadsheet to PDF.
Comments