Columns in Registered Trial Search Results - Include v4.4

The unique ID assigned to the trial by the CTRP.

The official name of the protocol provided by the study principal investigator or sponsor (as it appears in the protocol document).

The 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.

The 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.

The

The 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).

The current stage or state of a clinical trial or study relative to its ability to enroll participants/patients. For valid ClinicalTrials.gov recruitment values, refer to Trial Status Values in the CTRP and ClinicalTrials.gov and Expanded Access Statuses.

The current status of the trial in the CTRP trial processing work flow. For information, refer to Trial Processing Statuses.

Actions that are applicable to the trial according to the processing rules:

• Update - Link used to initiate trial updates. For instructions, refer to Updating Trials.
• Amend - Link used to initiate trial amendments. Available for trials with processing statuses abstraction verified (response/no response). For instructions, refer to Amending Complete Trials.
• Change Status - Link used to initiate a change to the trial status and status dates. For instructions, refer to Updating Trial Statuses.
• Add My Site - Link used to initiate adding an organization as a participating site. For instructions, refer to Adding Your Site to Abbreviated Trials.
• Update My Site - Link available to Participating Site Record owners to initiate participating site information changes. For instructions, refer to Updating Participating Site Organization Records.

• Request TSR and XML documents (for Complete trials) - Documents are sent via email to all trial owners. For instructions, refer to Viewing Trial Summary Reports and XML Documents.

• Verify Trial Data - Link used to verify open trial records twice per year to ensure that information is accurate and up-to-date. For instructions, refer to Verifying Trial Data.

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

The

For information, refer to About Accrual and Recording Trial Details. 

The phase of investigation, as defined by the US FDA for trials involving investigational new drugs. For information, refer to Trial Phase Value Definitions.

The main reason for conducting the trial. For information, refer to Primary Purpose Value Definitions.

The category of the trial, as determined by the submission of a full protocol (Complete) or a ClinicalTrials.gov import (Abbreviated). For information, refer to CTRP Trial Categories, Study Sources.

The date on which the enrollment of participants for a clinical study began (or will begin).

The 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.

The 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.

The type of Data Table 4 funding sponsorship (National, Externally Peer-Reviewed, Institutional, or Industrial). For information, refer to CTRP Trial Categories, Study Sources.

The 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.

The name of CTRP user who submitted the trial.

The 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).