DT4 Data Elements - Include 20170712

The following table describes the data elements displayed in the Data Table 4 Reports.

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.

P30 Grant Number

Cancer Center Support Grant number.

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

Clinical Research Cat

Clinical Research Category as follows:

INT = Interventional trial
OBS = Observational, non-interventional trial
ANC/COR = Ancillary/Correlative non-interventional trial

Study Source

CTRP Data Table 4 Funding Category as follows:

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

Specific Funding Source

CTRP organizations listed as Data Table 4 Funding Sponsor for the trial.

Primary Site

Data Table 4 Anatomic Sites for the trial.

NCT ID

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Protocol ID

Lead Org ID.

Other Protocol IDs

Multiple IDs, including the following:

NCI
CTEP or DCP
Other IDs

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.

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

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(ram) Code

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 within the date range given.

Close Date

Date on which the trial status was Closed to Accrual or Closed to Accrual and Intervention.

Phase

When you specify trial data in CTRP, the system requires you to specify the phase of investigation, as defined by the US FDA for trials involving investigational new drugs. The following table provides a definition of each phase and maps the ClinicalTrials.gov values to the CTRP values:

CTRP Phase Value	ClinicalTrials.gov Phase Value	Definition
Early Phase I	Early Phase 1 (Formerly listed as "Phase 0")	Exploratory trials, involving very limited human exposure, with no therapeutic or diagnostic intent (e.g., screening studies, microdose studies). See FDA guidance on exploratory IND studies for more information.
I	Phase 1	Includes initial studies to determine the metabolism and pharmacologic actions of drugs in humans, the side effects associated with increasing doses, and to gain early evidence of effectiveness; may include healthy participants and/or patients.
I/II	Phase 1/Phase 2	Trials that are a combination of phases 1 and 2.
II	Phase 2	Includes controlled clinical studies conducted to evaluate the effectiveness of the drug for a particular indication or indications in participants with the disease or condition under study and to determine the common short-term side effects and risks.
II/III	Phase 2/Phase 3	Trials that are a combination of phases 2 and 3.
III	Phase 3	Includes trials conducted after preliminary evidence suggesting effectiveness of the drug has been obtained, and are intended to gather additional information to evaluate the overall benefit-risk relationship of the drug.
IV	Phase 4	Studies of FDA-approved drugs to delineate additional information including the drug's risks, benefits, and optimal use.
NA	N/A	Trials without phases (for example, studies of devices or behavioral interventions).

Primary Purpose

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 Recording Trial Details.

Official Title

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

Entire Study

Target accrual for the entire trial if the Cancer Center that you selected is the lead organization. A blank field indicates that the Cancer Center you selected is not the lead organization.

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, if the value is not available in CTRP, it should be reported under this column if otherwise available.

Center Reporting Period

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):

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 Subject Registration Date as the cut-off date.

If summary accrual was reported (such as for Industrial trials), 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.

Center to Date

Total number of subjects accrued to date for the trial for all organizations in the Cancer Center Family with the relationship “Organization”.

Other Reporting Period

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):

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 Subject Registration Date as the cut-off date.

If summary accrual was reported (such as for Industrial trials), 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 accrual for the time period.

Other to Date

Total number of subjects accrued to date for the trial for all organizations in the Cancer Center Family with the relationship “Affiliation”.

Comments

In Jasper, this column is intentionally blank. To use this column:

Export the report to Microsoft Excel. For instructions, refer to Exporting Reports.
In the spreadsheet, add comments to this column.
Print the spreadsheet to PDF.

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