The following table describes the data elements displayed in the NCI As Sponsor Trials report for each trial:
| Data Element | Description |
|---|---|
| NCI ID | unique ID assigned to the trial by the CTRP. |
| Lead Org ID | 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. For more information, refer to Abstracting Trial Descriptions, Titles, and Identifiers. |
| Title | official name of the protocol provided by the study principal investigator or sponsor (as it appears in the protocol document). For more information, refer to Abstracting Trial Descriptions, Titles, and Identifiers. |
| Lead 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 | name of the organization responsible for the trial's research protocol, and responsible for the overall scientific and administrative coordination, study monitoring, and data management activities of the trial. For more information, refer to Abstracting Sponsors and Responsible Parties. |
| 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). For more information, refer to Abstracting Trial Descriptions, Titles, and Identifiers. |
| 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 | Unable to render {include} The included page could not be found. For more information, refer to Abstracting Sponsors and Responsible Parties. |
| Sponsor Org | name of the primary organization that oversees the implementation of the study and is responsible for data analysis, as defined in 21 CFR 50.3. For more information, refer to Abstracting Sponsors and Responsible Parties. |
| Responsible Party | party who is responsible for submitting information about a clinical study and updating that information, as defined by FDAAA. The responsible party can be the sponsor, sponsor-investigator, or sponsor-designated principal investigator. For more information, refer to Abstracting Sponsors and Responsible Parties. |
| 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 | current stage or state of a clinical trial or study relative to its ability to enroll participants/patients. Also refer to Abstracting Trial Statuses. |
| Trial Status Date | Date on which the current trial status became effective. For more information, refer to Abstracting Trial Statuses. |
| Trial Start Date | date on which the enrollment of participants for a clinical study began (or will begin). For more information, refer to Abstracting Trial Statuses. |
| Primary Completion Date | date that the final subject was (or will be) examined or received (or will receive) an intervention for the purposes of final collection of data for the primary outcome, whether the clinical trial concluded according to the prespecified protocol or was terminated (as specified in US Public Law 110-85, Title VIII, Section 801, with respect to an applicable clinical trial). For more information, refer to Abstracting Trial Statuses. |
| 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 | current status of the trial in the CTRP trial processing work flow. Also refer to Abstracting Trial Statuses. |
| Study Category | category of the trial, as determined by the submission of a full protocol (Complete) or a ClinicalTrials.gov import (Abbreviated). For more information, refer to Abstracting NCI-Specific Information. |
| 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. |
