Data Elements Included in the CTRP Trial Milestone Report - Include 20170510

The trial to which the milestone applies. The unique ID assigned to the trial by the CTRP.

The submission type of the trial to which the milestone applies, whether the trial is an original submission or an amendment. For information, refer to Processing Trial History Information.

The category of the trial to which the milestone applies. 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 or Abstracting NCI-Specific Information.

The submission to which the milestone applies, as a number identifying the trial record in the sequence of submissions for that trial. An original submission is submission 1. For information, refer to Processing Trial History Information.

The primary investigative techniques used in the protocol (interventional or non-interventional). The non-interventional category includes observational and ancillary/correlative studies. For information, refer to Trial Types and Subtypes, Abstracting Interventional Trial Design, or Abstracting Non-Interventional Trial Design.

The trial subtype: observational or ancillary/correlative. A subtype is available only for non-interventional trials. For information, refer to Trial Types and Subtypes or Abstracting Non-Interventional Trial Design. 

The main reason for conducting the trial. For information, refer to Primary Purpose Value Definitions, Abstracting Interventional Trial Design, or Abstracting Non-Interventional Trial Design.

Any text entered for the trial, as a detailed description of the trial’s primary purpose, if the primary purpose is Other. For information, refer to Abstracting Interventional Trial Design or Abstracting Non-Interventional Trial Design.

The secondary reason for conducting the trial. For information, refer to Abstracting Interventional Trial Design.

Any text entered for the trial, as a detailed description of the trial’s secondary purpose, if the secondary purpose is Other. For information, refer to Abstracting Interventional Trial Design.

The lead organization on the trial to which CTRO added the milestone. 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. For information, refer to Abstracting Sponsors and Responsible Parties.