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Data ElementDescription
NCI ID

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Trial Attribute NCI ID - Include v4.4
Trial Attribute NCI ID - Include v4.4

Lead Org ID

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Trial Attribute Lead Org Trial ID - Include v4.4
Trial Attribute Lead Org Trial ID - Include v4.4
 For more information, refer to Abstracting Trial Descriptions, Titles, and Identifiers.

Title
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Trial Attribute Official Title - Include v4.4
Trial Attribute Official Title - Include v4.4
 For more information, refer to Abstracting Trial Descriptions, Titles, and Identifiers.
Lead Organization PO IDIdentifier 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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Trial Attribute Lead Org Name - Include v4.4
Trial Attribute Lead Org Name - Include v4.4
 For more information, refer to Abstracting Sponsors and Responsible Parties.

NCT ID

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Trial Attribute NCT ID - Include v4.4
Trial Attribute NCT ID - Include v4.4
 For more information, refer to Abstracting Trial Descriptions, Titles, and Identifiers.

CTEP ID

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Trial Attribute CTEP ID - Include v4.4
Trial Attribute CTEP ID - Include v4.4

Identifier assigned to this trial by the CTEP (Cancer Therapy Evaluation Program).
DCP ID

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Trial Attribute DCP ID

Identifier assigned to this trial by the DCP (Division of Cancer Prevention).

- Include v4.4
Trial Attribute DCP ID - Include v4.4
For more information, refer to Abstracting Trial Descriptions, Titles, and Identifiers.

Funding Mechanism

A

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Trial Attribute Funding Mechanism - Include v4.4
Trial Attribute Funding Mechanism - Include v4.4

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/ProgramNCI organizational unit that provides funding for the trial, as

The NCI division or program identified in an IND, IDE, or grant record, as the

Include Page
Trial Attribute NCI Div Prog - Include v4.4
Trial Attribute NCI Div Prog - Include v4.4
For more information, refer to Abstracting INDs and IDEs or Abstracting Funding.

Institution Code

The NIH institution associated with the trial, as identified in an IND or IDE record. It is a 

Include Page
Trial Attribute Institution Code - Include v4.4
Trial Attribute Institution Code - Include v4.4
For more information, refer to Abstracting INDs and IDEs.

IND/IDE GrantorName of the organization that holds the IND/IDE approval for the trial.

Include Page
Trial Attribute IND IDE Grantor

- Include v4.4
Trial Attribute IND IDE Grantor - Include v4.4

For more information, refer to Abstracting INDs and IDEs.

IND/IDE Holder TypeType of organization that holds the IND/IDE approval for the trial.

The

Include Page
Trial Attribute IND IDE Holder Type - Include v4.4
Trial Attribute IND IDE Holder Type - Include v4.4

For more information, refer to Abstracting INDs and IDEs.

IND/IDE NumberNumber assigned to an IND or IDE.

The

Include Page
Trial Attribute IND IDE Number - Include v4.4
Trial Attribute IND IDE Number - Include v4.4
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).

Include Page
Trial Attribute IND IDE Type - Include v4.4
Trial Attribute IND IDE Type - Include v4.4
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.

Include Page
Trial Attribute 801 Indicator - Include v4.4
Trial Attribute 801 Indicator - Include v4.4
For more information, refer to Abstracting Regulatory Information.

Principal Investigator

Include Page
Trial Attribute PI - Include v4.4
Trial Attribute PI - Include v4.4
 For more information, refer to Abstracting Sponsors and Responsible Parties.

Sponsor Org

Include Page
Trial Attribute Sponsor - Include v4.4
Trial Attribute Sponsor - Include v4.4
 For more information, refer to Abstracting Sponsors and Responsible Parties.

Responsible Party

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Trial Attribute Responsible Party - Include v4.4
Trial Attribute Responsible Party - Include v4.4
 For more information, refer to Abstracting Sponsors and Responsible Parties.

Summary 4 Funding Sponsor

The

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Trial Attribute DT4 Funding Sponsor Org - Include v4.4
Trial Attribute DT4 Funding Sponsor Org - Include v4.4

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 Attribute Current Trial Status - Include v4.4
Trial Attribute Current Trial Status - Include v4.4
Also refer to Abstracting Trial Statuses.

Trial Status Date

The

Include Page
Trial Attribute Trial Status Date - Include v4.4

Date on which the current trial status became effective.

Trial Attribute Trial Status Date - Include v4.4
For more information, refer to Abstracting Trial Statuses.

Trial Start Date

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Trial Attribute Trial Start Date - Include v4.4
Trial Attribute Trial Start Date - Include v4.4
 For more information, refer to Abstracting Trial Statuses.

Primary Completion Date

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Trial Attribute Primary Completion Date - Include v4.4
Trial Attribute Primary Completion Date - Include v4.4
 For more information, refer to Abstracting Trial Statuses.

Primary Completion Date Type

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Trial Attribute 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).

- Include v4.4
Trial Attribute Primary Completion Date Type - Include v4.4
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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Trial Attribute Current Trial Processing Status - Include v4.4
Trial Attribute Current Trial Processing Status - Include v4.4
Also refer to Abstracting Trial Statuses.

Study Category

Include Page
Trial Attribute Study Source Category - Include v4.4
Trial Attribute Study Source Category - Include v4.4
 For more information, refer to Abstracting NCI-Specific Information.

Submission Number

A

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Trial Attribute Submission Number - Include v4.4
Trial Attribute Submission Number - Include v4.4

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 TypeValue indicating whether the trial record is an original submission or an amendment.

A value indicating

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Trial Attribute Submission Type OA - Include v4.4
Trial Attribute Submission Type OA - Include v4.4
For more information, refer to Processing Trial History Information.

Trial Summary Report Sent DateDate 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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