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CTRP Data Element | Description of CTRP Data Element | CCSG Column Name | ||||||
P30 Grant Number | Cancer Center Support Grant number.
| 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 the source category as N, E, I. As the DT4 report is not calling out how the trial is entered, only the content. | 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 |
| 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 |