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P30 Grant Number

Clinical Research Cat

Study Source

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. For a list of values, refer to Anatomic Sites.

Protocol ID

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

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

The report displays the last 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

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

Primary Purpose

• 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.

Official Title

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.

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.

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.

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.

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”.

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.