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Comment: For CTRPMICRO-368, revised based on response from Michael Izbicki in JIRA.

Upon trial abstraction validation or abstraction update, you can send the 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.
  • XML File – System-generated report that contains abstracted data in the format suitable for submission to ClinicalTrials.gov. This document is sent only to trial submitters who indicated that If a trial owner requires an XML file is required for submission to ClinicalTrials.gov, that user must first make sure the trial record in CTRP has all of the trial attributes required by ClinicalTrials.gov. For details, you can refer such users to Viewing Trial Summary Reports and XML Documents.