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Comment: I need to get clarification on the "Institution Code" column.

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Data ElementDescription
NCI _ IDThe
Include Page
Trial Attribute NCI ID - Include v4.4
Trial Attribute NCI ID - Include v4.4
Lead _ Org _ ID

The

Include Page
Trial Attribute Lead Org Trial ID - Include v4.4
Trial Attribute Lead Org Trial ID - Include v4.4
 For

more
Title

The

Include Page
Trial Attribute Official Title - Include v4.4
Trial Attribute Official Title - Include v4.4
 For

more
Lead Org Organization PO IDIdentifier The unique ID assigned to the lead organization by the CTRP. For more information, refer to Abstracting Trial Descriptions, Titles, and Identifiers.
Lead _ Organization

The

Include Page
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

The

Include Page
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

The

Include Page
Trial Attribute CTEP

_

ID

Identifier assigned to this trial by the CTEP (Cancer Therapy Evaluation Program). For more

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

DCP ID

The

Include Page
Trial Attribute DCP

_

ID

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

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

Funding MechanismUnique, 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

A

Include Page
Trial Attribute Funding Mechanism - Include v4.4
Trial Attribute Funding Mechanism - Include v4.4
For information, refer to Funding Mechanism Code Values or

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 
Institution Code

The NIH institution associated with the trial, as identified in an IND, IDE, or

IDE

grant record.

For more
IND/IDE Grantor

The

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

For

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

The

Include Page

Type of organization that holds the IND/IDE approval for the trial. For more

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

For information, refer to Abstracting INDs and IDEs.

IND/IDE Number

The

Include Page

Number assigned to an IND or IDE. For more

Trial Attribute IND IDE Number - Include v4.4
Trial Attribute IND IDE Number - Include v4.4
For information, refer to Abstracting INDs and IDEs.

IND/IDE TypesValue indicating whether the trial involves an Investigational New Drug Application (IND) or Investigational Device Exemption (IDE). For more

A value indicating

Include Page
Trial Attribute IND IDE Type - Include v4.4
Trial Attribute IND IDE Type - Include v4.4
For information, refer to Abstracting INDs and IDEs.

Section _ 801 _ IndicatorValue 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

A value indicating

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

Principal _ Investigator

The

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

The

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

The

Include Page
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

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

CTRP organizations listed as Data Table 4 Funding Sponsor for the trial. For more
Trial _ Status

The

Include Page
Trial Attribute Current Trial Status - Include v4.4
Trial Attribute Current Trial Status - Include v4.4
Also For information, refer to Trial Status Values in the CTRP and ClinicalTrials.gov and Abstracting Trial Statuses.

Trial _ Status _ Date

The

Date on which the current trial status became effective. For more

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

Trial _ Start _ Date

The

Include Page
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

The

Include Page
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

A

Include Page
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). For more

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

Submitting _ Org _ NameName

The name of the organization that submitted the trial.

Current Processing Status

The

Include Page
Trial Attribute Current Trial Processing Status - Include v4.4
Trial Attribute Current Trial Processing Status - Include v4.4
Also For information, refer to Trial Processing Statuses and Abstracting Trial Statuses.

Study _ Category

The

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

Submission Number

A

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

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. For more

A value indicating

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

Trial Summary Report Sent DateDate The 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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