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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. 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 Element

Description of CTRP Data Element

CCSG Column Name

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.

(No column)
Reporting Period Start Date

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

ReportingStartDate

Reporting Period End Date

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

ReportingEndDate

Trial Type Indicator

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

(No column)
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).

FY

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

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.

GrantNumber

Clinical Research Cat

Clinical Research Category. The primary investigative techniques used in the protocol (interventional or non-interventional). The non-interventional category includes observational and ancillary/correlative studies. The report uses the following abbreviations:

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

Study Source

type of Data Table 4 funding sponsorship (National, Externally Peer-Reviewed, Institutional, or Industrial). 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 CTRP organizations listed as Data Table 4 Funding Sponsor for the trial. Sponsor or source of the funding mechanism. 

FundingSource

Primary Site

The

The Data Table 4 Anatomic Sites for the trial. The anatomic site(s) on which the trial or study is focused.  If a Clinical Research Study covers more than one Anatomic Site, the Site column should be coded “multiple.”

PrimarySite
NCT ID

The unique ID assigned to the trial by the National Clinical Trial program (ClinicalTrials.gov) for trials that have been submitted to ClinicalTrials.gov Protocol Registration System (PRS) previously. This ClinicalTrials.gov ID appears as "NCT" followed by 8 numeric characters (such as NCT12345678).

NCTNumber

Protocol ID

Lead Org ID. 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.

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)
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?

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

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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).
LastName, FirstName, MiddleName

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. 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

Phase

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

Phase
Pilot

Indicates whether the trial is a pilot trial.

(No column)

Primary Purpose

main reason for conducting the trial. 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

official name of the protocol provided by the study principal investigator or sponsor (as it appears in the protocol document).

OfficialTitle
Entire StudyAnticipated (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 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 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 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 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
Comments

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

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