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. Unable to render {include} The included page could not be found. | (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. The non-interventional category includes observational and ancillary/correlative studies. The report uses the following abbreviations:
| ClinicalResearchCat |
Study Source | CTRP Data Table 4 Funding Category. The type of Data Table 4 funding sponsorship. The report uses the following abbreviations:
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 | CTRP organizations listed as Data Table 4 Funding Sponsor for the trial. Sponsor or source of the funding mechanism. | FundingSource |
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. | PrimarySite |
| NCT ID | 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. 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. | ProtocolID |
| Other Protocol IDs | Additional IDs assigned to the trial, including the following:
| (No column) |
| Local Trial ID | The 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:
| MultiInst? |
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:
| 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:
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:
When you generate the report, the system considers:
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. For details, refer to Trial Phase Value Definitions. | Phase |
| Pilot | Indicates whether the trial is a pilot trial. | (No column) |
Primary Purpose | Primary purpose the trial, as follows:
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. | OfficialTitle |
| Entire Study | Anticipated (target) number of subjects (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. | 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.
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.
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:
| Comments |
