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| Data Element | Description | ||||||
|---|---|---|---|---|---|---|---|
| NCI _ ID |
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| Lead _ Org _ ID |
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| Title |
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| Lead Org Organization PO ID | Identifier assigned to the lead organization by the CTRP. For more information, refer to Abstracting Trial Descriptions, Titles, and Identifiers. | ||||||
| Lead _ Organization |
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| NCT _ ID |
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| CTEP _ ID | Identifier assigned to this trial by the CTEP (Cancer Therapy Evaluation Program). For more information, refer to Abstracting Trial Descriptions, Titles, and Identifiers. | ||||||
| DCP _ ID | Identifier assigned to this trial by the DCP (Division of Cancer Prevention). For more information, refer to Abstracting Trial Descriptions, Titles, and Identifiers. | ||||||
| Funding Mechanism | Unique, three-character code for the funding mechanism of a grant on a trial. NIH assigns these codes to areas of extramural research activity. For more information, refer to Abstracting Funding. | ||||||
| NCI Division/Program | NCI organizational unit that provides funding for the trial, as identified in an IND, IDE, or grant record. For more information, refer to Abstracting INDs and IDEs or Abstracting Funding. | ||||||
| Institution Code | NIH institution associated with the trial, as identified in an IND or IDE record. For more information, refer to Abstracting INDs and IDEs. | ||||||
| IND/IDE Grantor | Name of the organization that holds the IND/IDE approval for the trial. For more information, refer to Abstracting INDs and IDEs. | ||||||
| IND/IDE Holder Type | Type of organization that holds the IND/IDE approval for the trial. For more information, refer to Abstracting INDs and IDEs. | ||||||
| IND/IDE Number | Number assigned to an IND or IDE. For more information, refer to Abstracting INDs and IDEs. | ||||||
| IND/IDE Types | Value indicating whether the trial involves an Investigational New Drug Application (IND) or Investigational Device Exemption (IDE). For more information, refer to Abstracting INDs and IDEs. | ||||||
| Section _ 801 _ Indicator | Value indicating whether the FDA-regulated interventional trial is an applicable trial as defined in US Public Law 110-85, Title VIII, Section 801. For more information, refer to Abstracting Regulatory Information. | ||||||
| Principal _ Investigator |
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| Sponsor _ Org |
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| Responsible _ Party |
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| Summary _ 4 _ Funding _ Sponsor | CTRP organizations listed as Data Table 4 Funding Sponsor for the trial. For more information, refer to Abstracting Sponsors and Responsible Parties. | ||||||
| Trial _ Status |
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| Trial _ Status _ Date | Date on which the current trial status became effective. For more information, refer to Abstracting Trial Statuses. | ||||||
| Trial _ Start _ Date |
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| Primary Completion Date |
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| Primary Completion Date Type | Value indicating whether the completion date is the one on which the trial is expected to complete (Anticipated), or the date on which it actually completed (Actual). For more information, refer to Abstracting Trial Statuses. | ||||||
| Submitting _ Org _ Name | Name of the organization that submitted the trial. | ||||||
| Current Processing Status |
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| Study _ Category |
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| Submission Number | Value identifying the trial record in the sequence of submissions for that trial. An original submission is submission 1. For more information, refer to Processing Trial History Information. | ||||||
| Trial Submission Type | Value indicating whether the trial record is an original submission or an amendment. For more information, refer to Processing Trial History Information. | ||||||
| Trial Summary Report Sent Date | Date on which the system sent the Trial Summary Report (TSR) to the principal investigator or trial submitter. For more information, refer to Processing Trial Milestones. |
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