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The following system-generated reports are available for each trial:

  • Trial Summary Report (TSR) – System-generated report that includes a summary of the abstraction in an easy-to-read format. Upon trial abstraction validation or abstraction update, you can send this report. The message instructs the submitter to review the TSR for accuracy and to report any changes to the CTRO staff. Also, in the CTRP Registration web application, a user can view the TSR for a Complete trial if that user is an owner of that trial.
  • XML File – System-generated report that contains abstracted data in the format suitable for submission to ClinicalTrials.gov. In the CTRP Registration web application, a user can view the XML document for a Complete trial if that user is an owner of that trial and if the trial meets specific criteria. If a trial owner requires an XML file for submission to ClinicalTrials.gov, that user may want to first make sure the trial record in CTRP has all of the trial attributes required for ClinicalTrials.gov, to avoid having to make corrections/additions in ClinicalTrials.gov.

For details, you can refer such users to Viewing Trial Summary Reports and XML Documents.