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Searching for Trial, Organization, and Person Records - Include v4.4
Searching for Trial, Organization, and Person Records - Include v4.4

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This section provides instructions for searching for trials, organizations, and persons currently registered with the CTRP.

In each case you are presented with a predefined set of search criteria that is appropriate for the type of search you are conducting. This section also provides instructions for reviewing trial-related documents and downloading Trial Summary Reports (TSRs) and XML documents.

Searching for Trials

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MultiExcerptNamesearchtrial

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You can retrieve existing trial records once you have registered for an account. See Creating CTRP Accounts.

After you have selected your search criteria, you can further limit or expand your search for trials as follows:

  • Use the Search All Trials feature to search for all trials registered with the CTRP from all organizations/accounts, whether or not you are the submitter or owner.
  • Use the Search My Trials feature to search for trials that you own, whether or not your organization is listed as the lead organization or participating site.
  • Use the Search Saved Drafts feature to search for trials that you have saved as drafts but have not submitted.

The search feature you choose determines which categories of trials will be returned, and the actions you can perform with those results, as shown in the table below. See Working with Search Results for rules that determine which trial details are displayed.

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Search Option

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Search All Trials

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Search My Trials

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Search Saved Drafts

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Types of Trials Returned

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All trials

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Partial Submissions

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Actions Permitted

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Verify Trials (for trials you submitted but may not own)

Info

The results of this search may include a subset of trials that you own or submitted.

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  • View Trial Details
  • Update Trials
  • Amend Trials
  • Request TSR/XML
  • Change Status
  • Add/Update My Site (Abbreviated trials only)
  • Verify Trials

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  • View Trial Details
  • Complete Submissions
  • Add/Update My Site (Abbreviated trials only)
Info

All registered users can search trials with the "Accepted" and subsequent processing status. Additionally, you can search for trials that you own that have not been validated. These trials are indicated by the "Submitted" status. See Trial Processing Statuses for information about statuses that occur during the course of the trial processing workflow.

How to Search for Existing Trials

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Select or enter the appropriate information in the drop-down lists and text fields. (You do not have to select or enter any search criteria if you use the Search My Trials feature. When searching All Trials, you must select or enter at least one search criterion.) The following table describes the fields.

Tip
titleTip

If you are searching for a saved draft, search by Phase, Purpose, or Title only. Because the system adds wildcards for you, do not enter wildcard symbols in the search fields.

Trial Search Criteria

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To search by this...

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Do this...

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Title

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Enter one or more words from the long title or name of the trial provided by the principal investigator or sponsor.

Tip
titleAvoid copying and pasting, or typing the entire title into the search field

Use keywords rather than phrases or the entire title. Doing so minimizes the potential for excluding from the search results any titles with misspellings or slightly different phrasing.

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Phase

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Pilot Trial?

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If the trial is a pilot, select Yes.

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Purpose

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Select the type of trial identifier from the drop-down list. Valid values are as follows:

  • NCI - NIH National Cancer Institute identifier
  • ClinicalTrials.gov (ClinicalTrials.gov Identifier) - Provide the exact number, including the ClinicalTrials.gov Identifier prefix. Example: NCT00012345
  • Lead Organization - Enter the unique identifier assigned to the trial by the lead organization
  • Other identifier - Additional trial identifier such as unique identifier from other registries, NIH grant numbers, or protocol numbers assigned by the Review Board
Tip
titleSelecting a Trial Identifier Type is not required

You can enter an identifier in the Identifier field without first having to choose an Identifier Type.

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Identifier

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Enter the unique identifier assigned to the trial by the NCI, ClinicalTrials.gov, PRS, or the identifier assigned to it by the lead organization. For Inter-Group trials, enter the Lead Group's trial number.

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Organization Type

Select one of the following organization roles from the drop-down list:

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Tip

You can change the Organization Type without affecting any other search criteria you may have selected previously.

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Organization

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Info

The system suggests organizations as you type.

Enter the initial letter(s) of the organization and then select the organization from the list of suggestions.

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To search for trials by organization without having to specify what role the organization plays in the trial, select Both from the Organization Type list, and then select the name of the organization of interest.

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Principal Investigator

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Info

The system suggests names as you type.

Enter the initial letter(s) of the principal investigator's last name and then select the investigator name from the list of suggestions.

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Search by Trial Category

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To restrict your search by trial category, select Abbreviated or Complete from the drop-down list. Otherwise, select Both.

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Click Search.

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Search menu showing list of searchable itemsImage Removed

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To search only the trials that you submitted or own, click My Trials. This feature enables access to all the trials that you have submitted, including those that are currently on hold. (The Clinical Trials Reporting Office staff places trials on hold when they are unable to process a trial without further information, usually from the submitter.)

-or-

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To clear all search criteria and begin a new search, click Reset.

Tip
titleAllow sufficient time for the system to conduct your search before you run your search again

The search is complete only when the system displays search results or alerts you that it could not find a trial to match your search criteria.

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Tip
titleYou can change Accrual Disease terminologies for individual trials

If you searched for "My Trials", the search results table displays an additional column, Accrual Disease Terminology. 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.

Clinical Trials Search Result Page showing disease code terminology columnImage Removed

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Searching for Organizations

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MultiExcerptNamesearchorganization

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You can search for organizations that are currently registered with the Clinical Trials Reporting Program by any of the following criteria:

  • Organization Identifying Information
    • PO ID - Enter the exact PO ID only
    • CTEP ID - Enter all or part of the CTEP ID
    • Name - Enter all or part of the Organization's name
    • Family Name. Enter all or part of the Organization Family's name
  • Organization Address
    • Country - Select the country from the drop-down list
    • City - Enter all or part of the organization's primary location
    • State - Select the state from the drop-down list
    • Zip Code - Enter all or part of the Zip code
  • Organization Type. Select one of the following:
    • Lead Organization - Returns organizations that are Lead Organizations
    • Participating Site - Returns organizations that are Participating Sites
    • Both - Returns organizations that are either Lead Organizations or Participating Sites

How to Search for Registered Organizations

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Provide as much information as you can about the organization you are looking for, or, enter the Person/Organization (PO) ID or Cancer Therapy Evaluation Program (CTEP) Identifier. You must enter search criteria in at least one field.

Note
titleSearching by PO ID

The PO ID you enter for your search criterion must be exact and complete. That is, do not use partial IDs or wildcards.

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titleUsing wildcard characters ( % )

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Click Search.
The organizations that meet your search criteria are listed in the Search Results table. To navigate the search results table, see Working with Tables and Search Results.
List of organization search resultsImage Removed

Tip
titleTip

If the organization you are searching for is not listed, you may have searched too narrowly (that is, you may have provided too much information about the organization). If the list of results is very long and contains many organizations that are similar to the one you are searching for, you can narrow your search by providing more information.

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  • To broaden your search so that more organizations are listed in the search results, delete one or more of your criteria. For example, if you searched by part of the organization’s name, city, state, and zip code in your original search, you may want to search by state alone.
    - or -
  • To narrow your search so that fewer organizations are listed in the search results, provide more about your organization. For example, if you searched by state in your original search, you may want to search by city in addition to the state.

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Searching for Persons

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MultiExcerptNamesearchperson

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You can search for persons that are currently registered with the Clinical Trials Reporting Program.

How to Search for Registered Persons

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Provide as much information as you can about the person you are looking for, or, enter the Person/Organization (PO) ID or Cancer Therapy Evaluation Program (CTEP) Identifier. To search by person role, select a role from the Person Role drop-down list. You must enter search criteria in at least one field.

Note
titleSearching by PO ID

The PO ID you enter for your search criterion must be exact and complete. That is, do not use partial IDs or wildcards.

Tip
titleUsing wildcard characters ( % )

You can enter a series of characters in any of the search fields (except the PO ID, which must be an exact match) to narrow the search results.

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Click Search.
The persons that meet your search criteria are listed in the Search Results table. To navigate the search results table, see Working with Tables and Search Results.
List of person search resultsImage Removed

Tip
titleTip

If the person you are searching for is not listed, you may have searched too narrowly (that is, you may have provided too much information about the person). If the list of results is very long and contains many persons that are similar to the one you are searching for, you can narrow your search by providing more information.

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  • To broaden your search so that more persons are listed in the search results, delete one or more of your criteria. For example, if you searched by part of the person’s name, city, state, and zip code in your original search, you may want to search by state alone.
    - or -
  • To narrow your search so that fewer persons are listed in the search results, provide more about your person. For example, if you searched by state in your original search, you may want to search by city in addition to the state.

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Clinical Trial Search Results

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MultiExcerptNamesearchtrialquery

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The Clinical Trials Reporting Office (CTRO) reviews each trial submitted to the system in order to validate submitted information. During the validation process, the reviewers check for duplicate records and ensure that the submitter has provided all required information. CTRO does one of the following as part of the validation/abstraction process:

  • If all data is complete and accurate, the reviewers assign the trial the status "Accepted," and the system notifies the submitter by email.
  • If information is missing, or there are discrepancies in the information provided, the reviewers can place a trial on hold. The CTRO contacts the submitter for clarification and/or to request missing documents, and resumes processing once the trial is validated.
  • If the trial is a duplicate (i.e., another user has submitted the same trial), the reviewers assign the trial the status "Rejected," and the system sends the submitter an email message indicating the status and reason for the rejection. Reviewers may also reject a trial if CTEP/DCP/CCR has approved the trial. NCI transfers these trials internally.
Info

If you have questions about a rejected trial, contact the CTRO at ncictro@mail.nih.gov.

The trials that match your search criteria are listed in search results tables. Which of the search results are displayed is determined by the following criteria:

  • Processing status of the trial at the time of the search. Trial statuses are listed and defined in Trial Processing Statuses.
    • Submitted - Original trial submitted but not validated
    • Amendment Submitted - Amendment submitted but not validated
    • Accepted - Trial passed validation
    • Rejected - Trial did not pass validation. These trials are not displayed.
    • Abstracted - Trial has been abstracted
    • Verification Pending - Trial has been abstracted, and the Trial Summary Report (TSR) has been sent to the trial submitter for abstraction verification
    • Abstraction Verified Response - Submitter has verified the abstraction as per the TSR, and has returned feedback to the CTRO within five business days after receiving the TSR
    • Abstraction Verified No Response - Submitter has not responded or returned verification feedback to the CTRO within five business days after receiving the TSR
  • User's role with respect to the trial. User roles include the following:
    • Site Administrator - Has full access to the trials led by the organization (plays lead organization role)
    • Trial Submitter/Owner - Has full access to the trials they own or submitted
    • Other user - Any user other than the trial submitter, owner, or trial's lead organization system administrator
  • Trial ownership. Trial ownership types are as follows:
    • Private trials - Trials submitted or owned by the user who is currently logged in to Registration
    • Public trials - Trials submitted by other registered users

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Trial records returned from "Search My Trials" and "Search All Trials" options display the following details and actions you can take for each trial when applicable.

Info

No data are displayed for Private trials with a processing status of Rejected nor for Public trials with a processing status of Submitted or Rejected.

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

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Column

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Displayed for Public trials?

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Description

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NCI Trial Identifier

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Yes

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Unique identifier assigned to the trial by the CTRP

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Title

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Yes

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

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Lead Organization

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Yes

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

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Lead Org (Organization) Trial Identifier

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Yes

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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.

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Principal Investigator

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Yes

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

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ClinicalTrials.gov Identifier

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Yes

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Number assigned to the trial by PRS (ClinicalTrials.gov) (for trials that have been submitted to ClinicalTrials.gov previously)

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Other Identifiers

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Yes

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

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Current Trial Status

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Yes

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

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Current (Trial) Processing Status

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No

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Stage in the trial processing work flow

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Available Actions

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Yes

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

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Note

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

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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.

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(Participating) Sites

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Yes

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

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Phase

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No

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

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Primary Purpose

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No

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Main purpose of the trial

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Category

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No

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Data Table 4 Funding Sponsorship or Trial Submission Category

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Trial Start Date

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No

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Date on which the trial starts

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Responsible Party

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No

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Responsible party, as defined by FDAAA

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Sponsor

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No

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

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Data Table 4 Funding Sponsor Type

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No

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Trial category selected for trial submission

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Record Verification Date

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No

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Date on which the CTRO validated the trial submission

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Submitter

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No

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Name of person who submitted the trial

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Primary Completion Date

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No

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

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Last Update Submitted

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No

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Date on which the trial was last updated

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Last Amendment Submitted

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No

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Date on which the trial was last amended

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Last Amender Name

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No

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Name of person who amended the trial

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On-Hold Reason

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No

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Reason why the trial was placed on hold

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
TitleOfficial name of the protocol provided by the study principal investigator or sponsor (same as in the protocol document)
Lead OrganizationOrganization responsible for the overall scientific and administrative coordination, study monitoring, and data management activities of a given clinical trial
Lead 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.

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Viewing Trial Details

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MultiExcerptNamesearchtrialview

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Trials you search for are listed in the Submitted Clinical Trials Search Results table as shown below.

Clinical Trials Search Results pageImage Removed

To view details for a given clinical trial listed on a search results page, click its associated NCI Trial Identifier hypertext link.
The details provided for a given trial depend on trial ownership (private or public) and Data Table 4 Category (Complete or Abbreviated).

The Trial Details page displays the metadata as entered by a trial submitter. The upper part of the Trial Details page is shown below. Refer to the Glossary of CTRP Terms for a description of the metadata.

Upper portion of the Trial Details page displaying recorded trial detailsImage Removed

Info

Responsible party, IND/IDE, NIH grant information and trial-related documents are only displayed for Private trials.

To return to the Search Trials page, scroll to the bottom of the Trial Details page, and click Back to Search Results.

 

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Exporting Search Results

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MultiExcerptNamesearchtrialexport

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You can export the results from any search you conduct in a format suitable for Excel or other spreadsheet application.

How to Export Search Results

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  • CSV - Exports comma-separated values to a resultsTrialSearch.csv file
  • Excel - Exports Excel-formatted data to a resultsTrialSearch.xsl file

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