NIH | National Cancer Institute | NCI Wiki  

Error rendering macro 'rw-search'

null

Versions Compared

Old Version 1

changes.mady.by.user Frost, Ruth (NIH/NCI) [C]

Saved on

compared with

New Version 2

changes.mady.by.user Frost, Ruth (NIH/NCI) [C]

Saved on

Key

  • This line was added.
  • This line was removed.
  • Formatting was changed.
Comment: Replaced contents of table cell with Include Page macro pointing to include page with same contents.

...

The following table describes the columns in the search results table:

Column

Displayed for Public trials?

Description

NCI Trial Identifier

Yes

Unique identifier assigned to the trial by the CTRP

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

Title

Yes

Official name of the protocol provided by the study principal investigator or sponsor (same as in the protocol document)

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

Lead Organization

Yes

Organization responsible for the overall scientific and administrative coordination, study monitoring, and data management activities of a given clinical trial

Include Page
Trial Attribute Lead Org Name - Include v4.4
Trial Attribute Lead Org Name - Include v4.4

Lead Org (Organization) Trial Identifier

Yes

Unique identification assigned to the protocol by the sponsoring organization, usually an accession number or a variation of a grant number. Multiple studies conducted under the same grant must each have a unique number.

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

Principal Investigator

Yes

Appointed investigator responsible for conducting the clinical trial, or, for multi-site trials, the study chair

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

ClinicalTrials.gov Identifier

Yes

Include Page
Trial Attribute NCT ID - Include v4.4
Trial Attribute NCT ID - Include v4.4

Other Identifiers

Yes

Identifiers other than Lead Organization Trial Identifier or ClinicalTrials.gov Identifier

Current Trial Status

Yes

Code that represents the status of a trial in relation to the ability to enroll participants/patients

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

Current (Trial) Processing Status

No

Stage in the trial processing work flow

Include Page
Trial Attribute Current Trial Processing Status - Include v4.4
Trial Attribute Current Trial Processing Status - Include v4.4

Available Actions

Yes

Actions that are applicable to the trial according to the processing rules
  • Update - Link used to initiate trial updates
  • Amend - Link used to initiate trial amendments. Available for trials with processing statuses abstraction verified (response/no response).
  • Change Status - Link used to initiate a change to the trial status and status dates
  • Add My Site - Link used to initiate adding an organization as a participating site
  • Update My Site - Link available to Participating Site Record owners to initiate participating site information changes

  • Request TSR and XML documents (for complete trials) - Documents are sent via email to all trial owners

  • Verify Trial Data - Link used to verify open trial records twice per year to ensure that information is accurate and up-to-date

    Anchor
    6262
    6262

    Note

    The actions available for a trial depend on its processing status and participating site record ownership.

Accrual Disease TerminologyNo
The disease terminology currently in use for accruals. You can select a new terminology from the drop-down list only if the trial has not accrued patients. Additionally, you can change accrual disease terminology at any time for trials currently recording accruals at the summary level only.

Include Page
Trial Attribute Accrual Disease Terminology - Include v4.4
Trial Attribute Accrual Disease Terminology - Include v4.4

(Participating) Sites

Yes

One or more organizations participating in the trial. Click View in the Sites column to view participating site details.

Phase

No

Phase of the investigation, as defined by the US FDA for trials involving investigational new drug

Include Page
Trial Attribute Phase - Include v4.4
Trial Attribute Phase - Include v4.4

Primary Purpose

No

Main purpose of the trial

Include Page
Trial Attribute Primary Purpose - Include v4.4
Trial Attribute Primary Purpose - Include v4.4

Category

No

Data Table 4 Funding Sponsorship or Trial Submission Category

Include Page
Trial Attribute Study Source Category - Include v4.4
Trial Attribute Study Source Category - Include v4.4

Trial Start Date

No

Include Page

Date on which the trial starts

Trial Attribute Trial Start Date - Include v4.4
Trial Attribute Trial Start Date - Include v4.4

Responsible Party

No

Include Page

Responsible party, as defined by FDAAA

Sponsor

No

Primary organization that oversees the implementation of the study and is responsible for data analysis as defined in 21 CFR 50.3

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

Sponsor

No

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

Data Table 4 Funding Sponsor Type

No

Trial category selected for trial submission

Include Page
Trial Attribute Study Source DT4 Funding - Include v4.4
Trial Attribute Study Source DT4 Funding - Include v4.4

Record Verification Date

No

Date on which the CTRO validated the trial submission

Include Page
Trial Attribute Record Verification Date - Include v4.4
Trial Attribute Record Verification Date - Include v4.4

Submitter

No

Name of person who submitted the trial

Include Page
Trial Attribute Submitter - Include v4.4
Trial Attribute Submitter - Include v4.4

Primary Completion Date

No

Include Page

Date on which the trial reaches/reached its primary completion date

Trial Attribute Primary Completion Date - Include v4.4
Trial Attribute Primary Completion Date - Include v4.4

Last Update Submitted

No

Date on which the trial was last updated

Last Updater NameNo

Name of the person who last updated the trial

Last Amendment Submitted

No

Date on which the trial was last amended

Last Amender Name

No

Name of person who amended the trial

On-Hold Reason

No

Include Page

Reason why the trial was placed on hold

Trial Attribute Hold Reason - Include v4.4
Trial Attribute Hold Reason - Include v4.4

Trial records returned from "Search Saved Drafts" display the following details and actions you can take for each trial when applicable:

ColumnDescription
Temporary Trial IdentifierUnique identifier that the system assigned to the saved draft
Title

Include Page
Trial Attribute Official Title - Include v4.4

Official name of the protocol provided by the study principal investigator or sponsor (same as in the protocol document)

Trial Attribute Official Title - Include v4.4

Lead Organization

Include Page
Trial Attribute Lead Org Name - Include v4.4
Trial Attribute Lead Org Name - Include v4.4

Lead Organization Trial Identifier

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

Lead OrganizationOrganization responsible for the overall scientific and administrative coordination, study monitoring, and data management activities of a given clinical trialLead Organization Trial IdentifierUnique identification assigned to the protocol by the sponsoring organization. Multiple studies conducted under the same grant must each have a unique number

Action
    • Complete - Link to initiate trial record completion
    • Delete - Link to initiate trial deletion
Info

Trial ownership and current processing status determine which of the trial details and actions listed above are displayed in the Search Results table. Refer to Trial Processing Statuses.