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The following table describes 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#dt4. The following tables describe the data elements displayed in the CTRP Data Table 4 Reports. Most of these elements appear in the report as columns. However, the cancer center, fiscal year, and date range appear in the report header.report, and demonstrate this alignment of data elements with the CCSG report.
For instructions on configuring the report, refer to Generating the CTRP Data Table 4 Report.
CTRP Data Table 4 reporting for interventional trials (non-competing CCSG applications) started in FY18 (after October 1, 2017). NCI transitioned to CTRP DT4 for interventional trials for competing CCSG applications in FY20 (started May 25, 2020 submissions).
CTRP Data Element | Description of CTRP Data Element | CCSG Column Name |
|---|---|---|
Cancer Center Organizational Family (Cancer Center Family already setup in CTRP which appears in CTRP Data Table report drop-down for your center) | The name of the CTRP organization family as defined by the Cancer Center. | |
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. 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) |
| Reporting Period Start Date (CTRP Data Table 4 selection criteria) | 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) | An indication whether the report includes data from a specific trial type or all trial types. For information, refer to Trial Types and Subtypes.
| (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) |
Scope of Trials on the Report
For a trial to be included on a Cancer Center’s CTRP Data Table 4 report, the trial must be “Open” at both the Overall Trial-level and at the Participating Site-level for the selected reporting period. CTRP DT4 logic looks at the first Open and first Closed recruitment statuses for the Overall Trial and the Site when deciding which trials to include on a report.
Open statuses include the following:
- Active
- Available
- Enrolling by Invitation
- Temporarily Closed to Accrual
- Temporarily Closed to Accrual and Intervention
- Temporarily Not Available
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 | The | |||||||||
| FY | 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). For instructions, refer to Generating the CTRP Data Table 4 Report Using Jasper. | |||||||||
| Date Range | Dates you have specified as the start date and end date for the reporting period. For instructions, refer to Generating the CTRP Data Table 4 Report Using Jasper. | |||||||||
P30 Grant Number | Cancer Center Support Grant number.
| GrantNumber | ||||||||
Clinical Research CatClinical Research Category. The primary investigative techniques used in the protocol. The non-interventional category includes observational and ancillary/correlative studiesResearch Category | The trial type. The
Note: Expanded Access studies are currently listed in CTRP under the Interventional trial category.
| ClinicalResearchCat | ||||||||
Study SourceCTRP Data Table 4 Funding Category. The type of Data Table 4 funding sponsorship | The
| |||||||||
Specific Funding Source | CTRP organizations listed as Data Table 4 Funding Sponsor for the trial. Sponsor or source of the funding mechanism. | |||||||||
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
| FundingSource | ||||||||
Primary Site | 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 Data Table 4 Anatomic | PrimarySite | |||||||
| NCT ID | The
| NCTID | ||||||||
| NCI ID | The
| NCIID | ||||||||
Protocol ID | The lead organization trial ID. The
| ProtocolID | ||||||||
| Other Protocol IDs | Additional IDs assigned to the trial, including the following:
| Is Multi Institutional? | OthProtocolID | |||||||
| Local Trial ID | The unique ID assigned at the Cancer Center level and used at the sites level to identify a trial. For instructions on specifying this information in CTRP, refer to Managing Local Trial IDs. Note: Identifier that the Cancer Center has provided which helps them to map the trial from their local CTMS to CTRP. | LocalTrialID | ||||||||
Is Multi Institutional? |
| IsMultiInst | ||||||||
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:
| |||||||||
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. | |||||||||
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. | |||||||||
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. | |||||||||
Middle Initial | The PI fields on the CTRP-generated DT4 report include the Last Name, First Name and Middle Initial of the PI from the Center who is responsible for the Clinical Research Study.
| |||||||||
Program Code | The
| ProgCode | ||||||||
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. | OpenDate | ||||||||
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. | CloseDate | ||||||||
Phase | The
| 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 | An indication
| IsPilot | ||||||||
Primary PurposePrimary purpose the trial, as follows | The
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 | The
| OfficialTitle | ||||||||
| Entire Study | Anticipated The anticipated (target) number of subjects (accrual) for the entire trial if the specified Cancer Center that you selected is the lead organization. A blank field indicates that the specified 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, if the value is not available in CTRP, it should be reported under in this column if otherwise available.it is at all available, whether in CTRP or otherwise. | YourCenterTotal | ||||||||
| Center Reporting Period | 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.
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 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. | CenterToDate | ||||||||
| Other Reporting Period | 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.
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 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”. | OtherToDate | ||||||||
| Entire Study Accrual To Date |
| Entire Study Accrual To Date | ||||||||
| Comments | Comments | In the CTRP reporting application, this column is intentionally blank. To use this column:
| Comments |
