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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) 

The 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 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) 

(No column)

( CTRP Data Table 4 report title)  

Fiscal Year

(CTRP Data Table 4 selection criteria) 

The annual period you have specified for the report (e.g., FY 2018 January 1, 2017-December 31, 2017).   

FY

(CTRP Data Table 4 report title) 

P30 Grant Number

Clinical Research Category

Clinical Research Cat

Clinical Research Category as follows:

Study SourceCTRP Data Table 4 Funding Category as follows

• 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.

Specific Funding Source

Primary Site

Protocol ID

Multiple Additional IDs assigned to the trial, including the following:

• CTEP or DCP
• Unique IDs from other registries
• NIH grant numbers
• Protocol numbers assigned by the review board
• Other IDs

Is Multi Institutional?

Is Multi Institutional?

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.

Middle Initial

• 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.

Program Code

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.

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.

Phase

Primary Purpose

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, if the value is not available in CTRP, it should be reported under in this column if otherwise availableit is at all available, whether in CTRP or otherwise.

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
  Subject Registration Date
  • 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 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.

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
  Subject Registration Date
  • 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 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”.

• 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.

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

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