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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/eData#dt4. The following tables describe the data elements displayed in the CTRP Data Table 4 Reports.

Some of these elements appear in the report header.

report, and demonstrate this alignment of data elements with the CCSG 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).

Report Using STRAP. For information, refer to Trial Types and Subtypes.

All
Interventional
Non-interventional

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)	The name of the CTRP organization family as defined by the Cancer Center.
Data Element	Description
Cancer Center	CTRP Organization Family Name. 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 Range	Dates you have specified as the start date and date for the reporting period.	ReportingStartDate (CTRP Data Table 4 report title)
Reporting Period End Date (CTRP Data Table 4 selection criteria)	The date you have specified as the end date for the reporting period. For instructions, refer to Generating the	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.
Include Page
Trial Types - Include v4.4	Trial Types - Include v4.4	(No column) ( CTRP Data Table 4 report title)
Fiscal Year (CTRP Data Table 4 selection criteria)	The annual	Fiscal Year	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). For instructions, refer to Generating the CTRP Data Table 4 Report Using STRAP.

Most of the elements appear in the report as columns.

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

(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.

CTRP Data Element	Description of CTRP Data Element	CCSG Column Name
P30 Grant Number	The

Data Element

Description

P30 Grant Number

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 CatClinical Research Category. The primary investigative techniques used in the protocol. The non-interventional category includes observational and ancillary/correlative studies

Research Category

The trial type. 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

CTRP Data Table 4 Funding Category. The type of Data Table 4 funding sponsorship

Specific Funding Source

CTRP organizations listed as Data Table 4 Funding Sponsor for the trial. Sponsor or source of the funding mechanism.

Primary Site

Data Table 4 Anatomic Sites for the trial. The anatomic site(s) on which the trial or study is focused.

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

, N, E, I for Industrial trials based on the following:

D = Industrial trials other than Consortia trials
N = Industrial Consortia trials, National
E = Industrial Consortia trials, Externally Peer-Reviewed’
I = Industrial Consortia trials, Institutional

= 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

Include Page

	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

Sites

Site Values.

PrimarySite

NCT ID

The

Include Page

	Trial Attribute NCT ID

field description

- Include v4.4
	Trial Attribute NCT

ID field description

ID - Include v4.4

NCTID

NCI ID

The

Include Page

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

NCIID

Protocol ID

The lead organization trial ID. The

Include Page

	Trial Attribute Lead Org Trial ID

. The unique ID assigned to the trial by the sponsoring organization, usually an accession number or a variation of a grant number. Multiple studies conducted under the same grant must each have a unique number.

- 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

Protocol numbers assigned by the review board Other IDs	OthProtocolID
Local Trial ID	The unique ID assigned at the Cancer Center level and used at the sites level to identify a trial.

Is Multi Institutional?

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

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.

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

Middle 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.

LastName, FirstName, MiddleName

Program Code

The

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

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

The

Include Page

	Trial Attribute Phase - Include v4.4
	Trial Attribute Phase - Include v4.4

Last name, first name, and middle initial of the Principal Investigator (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).

Prog Code

Program Code. Alphanumeric code that identifies the clinical research program. A code assigned by the Cancer Center to each participating site on a trial to classify the type of cancer research being conducted by the trial at that site.

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.

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.

Phase

Phase of investigation, as defined by the US FDA for trials involving investigational new drugs.

For details, refer to Trial Phase Value Definitions.

Phase

Pilot

An indication

Include Page

	Trial Attribute Pilot

Indicates whether the trial is a pilot trial.

Primary Purpose

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

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

Primary purpose the trial, as follows

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

Official name of the protocol provided by the study principal investigator or sponsor

	Trial Attribute Official Title - Include v4.4

OfficialTitle

Entire Study

Anticipated

The anticipated (target) number of subjects (accrual) for the entire trial if the specified Cancer Center

that you selected

is the lead organization. A blank field indicates that the specified Cancer Center

you selected

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

is not available in CTRP, it

should be reported

under

in this column if

otherwise available.

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.

Other12Mos

Other to Date

Total CommentsIn the CTRP reporting application, this column is intentionally blank.

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
Comments

To use this column:

Export the report to Microsoft Excel. For instructions, refer to Working with CTRP Automated Reports.
In the spreadsheet, add comments to this column. (NCI recommends up to 50 characters.)
Print the spreadsheet to PDF.

Comments

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