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

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Data ElementDescription
NCI _ IDThe
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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

Identifier assigned to this trial by the CTRP.Lead_Org_IDIdentifier assigned to this trial by the lead organization. For more
Title

The

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Trial Attribute Official Title - Include v4.4

Official name of the protocol provided by the study principal investigator or sponsor. For more

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

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

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

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 _ IDIdentifier assigned to this trial by the National Clinical Trial program (ClinicalTrials.gov). For more

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 _IDID

The

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

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

The

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Trial Attribute DCP ID - Include v4.4
Trial Attribute DCP ID - Include v4.4
For

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

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

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

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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 _InvestigatorInvestigator

The

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

Principal Investigator (PI) for the trial. For more
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

The

Include Page
Trial Attribute Responsible Party - Include v4.4
Trial Attribute Responsible Party - Include v4.4
 For

Name of the organization responsible for the trial. The responsible party can be either a sponsor, principal investigator (PI), or sponsor/investigator. For more
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 _StatusStatus

The

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Trial Attribute Current Trial Status - Include v4.4
Trial Attribute Current Trial Status - Include v4.4
For

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 Statuses and Trial
Trial Status Date

The

Include Page
Trial

_

Attribute Trial Status

_

Date - Include v4.4

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

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

Trial_Start_DateDate 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

The

Date on which the final subject was examined or received an intervention, or the date on which that is expected to happen. For more

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

Primary Completion Date Type

A

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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). 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

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Trial Attribute Current Trial Processing Status

Value indicating the current processing status of the trial. For more

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

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

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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