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

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Data ElementDescription
NCI _IDIdentifier assigned to this trial by the CTRP.
Lead_Org_IDIdentifier assigned to this trial by the lead organization.
TitleOfficial name of the protocol provided by the study principal investigator or sponsor.
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 information, refer to Abstracting Trial Descriptions, Titles, and Identifiers.

Title

The

Include Page
Trial Attribute Official Title - Include v4.4
Trial Attribute Official Title - Include v4.4
 For information, refer to Abstracting Trial Descriptions, Titles, and Identifiers.

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

The

Name of the principal administrative organization responsible for this trial's research protocol. For more

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

CTEP ID

The

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

Identifier assigned to this trial by the National Clinical Trial program (ClinicalTrials.gov).CTEP_IDIdentifier assigned to this trial by the CTEP (Cancer Therapy Evaluation Program). For more
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 Mechanism

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 Abstracting Funding.

NCI Division/Program 

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 information, refer to NCI Division and Program Values, Abstracting INDs and IDEs, or Abstracting Funding.

Institution Code

The NIH institution associated with the trial, as identified in an IND, IDE, or grant record. For information, refer to NIH Institution Code Values, NIH Grant Institute Code Values, Abstracting INDs and IDEs, or Abstracting Funding.

Institution Code 

IND/IDE Grantor 

The

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

For information, refer to Abstracting INDs and IDEs.

IND/IDE Holder Type 

The

Include Page
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
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 Types 

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 Indicator

A value indicating

Include Page
Trial Attribute 801 Indicator - Include v4.4
Trial Attribute 801 Indicator - Include v4.4
For

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

information, refer to Abstracting Regulatory Information.

Principal _ InvestigatorPrincipal Investigator (PI) for the trial

The

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

Sponsor _OrgOrg

The

Include Page
Trial Attribute Sponsor - Include v4.4
Trial Attribute Sponsor - Include v4.4
 For

Name of the primary organization that oversees implementation of study and is responsible for data analysis. For more
Responsible _Party 
Summary_4_Funding_SponsorCTRP organizations listed as Data Table 4 Funding Sponsor for the trial.
Party

The

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

Trial StatusTrial_StatusCurrent 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

The

Include Page
Trial Attribute Current Trial Status - Include v4.4
Trial Attribute Current Trial Status - Include v4.4
For information, refer to

Trial_Status_DateDate on which the current trial status became effective.
Trial_Start_Date 
Trial Status Date

The

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 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

Primary Completion DateDate 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

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 _ Name 

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
For

Current Processing StatusValue indicating the current processing status of the trial. For more

information, refer to

Abstracting Processing in the CTRP

.

Study _ Category

The

Data Table 4 Funding Sponsorship or Trial Submission Category (study source): Complete or Abbreviated.
Submission Number 

Include Page
Trial Attribute Study Source Category - Include v4.4
Trial Attribute Study Source Category - Include v4.4
 For information, refer 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 information, refer to Processing Trial History Information.

Trial Submission Type

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 Submission Type 

Trial Summary Report Sent Date 

...

hiddentrue

...

The date on which the system sent the Trial Summary Report (TSR) to the principal investigator or trial submitter. For information, refer to Processing Trial Milestones.