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CTRP Data Element | Description of CTRP Data Element | CCSG Column Name | ||||||
---|---|---|---|---|---|---|---|---|
P30 Grant Number | The Cancer Center Support Grant number.
| GrantNumber | ||||||
Clinical Research Category | The trial type. The
Note: Expanded Access studies are currently listed in CTRP under the Interventional trial category.
| ClinicalResearchCat | ||||||
Study Source | The
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 |
For a list of values, refer to Data Table 4 Anatomic Site Values. | 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:
| 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, 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 | ||||||
Pilot | An indication
| IsPilot | ||||||
Primary Purpose | 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 | ||||||
Pragmatic TrialPrag | An indication as to whether the trial is a pragmatic (prag) trial. | Pragmatic TrialPrag | ||||||
Official Title | The
| OfficialTitle | ||||||
Entire Study | The anticipated (target) number of subjects (accrual) for the entire trial if the specified Cancer Center is the lead organization. A blank field indicates that the specified Cancer Center 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 | 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 | 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 | 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 | 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 | To use this column:
| Comments |