The following table describes the data elements displayed in the NCI As Sponsor Trials report for each trial:
Data Element | Description |
---|---|
NCI_ID | Identifier assigned to this trial by the CTRP. |
Lead_Org_ID | Identifier assigned to this trial by the lead organization. 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. For more information, refer to Abstracting Trial Descriptions, Titles, and Identifiers. |
Lead Org 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 principal administrative organization responsible for this trial's research protocol. For more information, refer to Abstracting Sponsors and Responsible Parties. |
NCT_ID | Identifier assigned to this trial by the National Clinical Trial program (ClinicalTrials.gov). 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 | Principal Investigator (PI) for the trial. For more information, refer to Abstracting Sponsors and Responsible Parties. |
Sponsor_Org | Name of the primary organization that oversees implementation of study and is responsible for data analysis. For more information, refer to Abstracting Sponsors and Responsible Parties. |
Responsible_Party | Name of the organization responsible for the trial. The responsible party can be either a sponsor, principal investigator (PI), or sponsor/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 other stages and its ability to enroll participants/patients. For more information, refer to Abstracting Trial Statuses and Trial Status Values in the CTRP and ClinicalTrials.gov. |
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 the trial started, or is expected to start. For more information, refer to Abstracting Trial Statuses. |
Primary Completion Date | Date on which the final subject was examined or received an intervention, or the date on which that is expected to happen. 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 | Value indicating the current processing status of the trial. For more information, refer to Abstracting Trial Statuses and Trial Processing Statuses in the CTRP. |
Study_Category | The Data Table 4 Funding Sponsorship or Trial Submission Category (study source): Complete or 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. |