Clinical Trial Search Results - Include v4.4

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.

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

(A business day is any weekday that is not a Federal holiday. For a list of Federal holidays, refer to the U.S. Office of Personnel Management's list of Federal Holidays.)

To navigate the search results table, see Working with Tables and Search Results.

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.

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:

Column	Displayed for Public trials?	Description
NCI Trial Identifier	Yes	unique ID assigned to the trial by the CTRP.
Title	Yes	official name of the protocol provided by the study principal investigator or sponsor (as it appears in the protocol document).
Lead Organization	Yes	name of the organization responsible for the trial's research protocol, and responsible for the overall scientific and administrative coordination, study monitoring, and data management activities of the trial.
Lead Org (Organization) Trial Identifier	Yes	unique ID assigned to the trial 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.
Principal Investigator	Yes	Unable to render {include} The included page could not be found.
ClinicalTrials.gov Identifier	Yes	unique ID assigned to the trial by the National Clinical Trial program (ClinicalTrials.gov) for trials that have been submitted to ClinicalTrials.gov Protocol Registration System (PRS) previously. This ClinicalTrials.gov ID appears as "NCT" followed by 8 numeric characters (such as NCT12345678).
Other Identifiers	Yes	Identifiers other than Lead Organization Trial Identifier or ClinicalTrials.gov Identifier.
Current Trial Status	Yes	current stage or state of a clinical trial or study relative to its ability to enroll participants/patients.
Current (Trial) Processing Status	No	current status of the trial in the CTRP trial processing work flow.
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 The actions available for a trial depend on its processing status and participating site record ownership.
Accrual Disease Terminology	No	disease terminology for reporting accruals. Keep in mind: For a trial recording accruals at the patient level, you can specify a new terminology only if the trial has not accrued patients. For a trial recording accruals at the summary level, you can change accrual disease terminology at any time.
(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 investigation, as defined by the US FDA for trials involving investigational new drugs.
Primary Purpose	No	main reason for conducting the trial.
Category	No	category of the trial, as determined by the submission of a full protocol (Complete) or a ClinicalTrials.gov import (Abbreviated).
Trial Start Date	No	date on which the enrollment of participants for a clinical study began (or will begin).
Responsible Party	No	party who is responsible for submitting information about a clinical study and updating that information, as defined by FDAAA. The responsible party can be the sponsor, sponsor-investigator, or sponsor-designated principal investigator.
Sponsor	No	name of the primary organization that oversees the implementation of the study and is responsible for data analysis, as defined in 21 CFR 50.3.
Data Table 4 Funding Sponsor Type	No	type of Data Table 4 funding sponsorship (National, Externally Peer-Reviewed, Institutional, or Industrial).
Record Verification Date	No	date on which the abstracted data for the trial was last verified. ClinicalTrials.gov displays the verification date along with an organization name to indicate to the public whether the information is being kept current, particularly recruiting status and contact information. In CTRP, the last verified date is the most recent date on which the CTRO confirmed all of a clinical study's information in CTRP as accurate and current.
Submitter	No	name of CTRP user who submitted the trial.
Primary Completion Date	No	date that the final subject was (or will be) examined or received (or will receive) an intervention for the purposes of final collection of data for the primary outcome, whether the clinical trial concluded according to the prespecified protocol or was terminated (as specified in US Public Law 110-85, Title VIII, Section 801, with respect to an applicable clinical trial).
Last Update Submitted	No	Date on which the trial was last updated.
Last Updater Name	No	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	reason why the abstractor put the trial on hold, if applicable.

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

Column	Description
Temporary Trial Identifier	Unique identifier that the system assigned to the saved draft
Title	official name of the protocol provided by the study principal investigator or sponsor (as it appears in the protocol document).
Lead Organization	name of the organization responsible for the trial's research protocol, and responsible for the overall scientific and administrative coordination, study monitoring, and data management activities of the trial.
Lead Organization Trial Identifier	unique ID assigned to the trial 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.
Action	Complete - Link to initiate trial record completion Delete - Link to initiate trial deletion

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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