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Upon trial abstraction validation or abstraction update, you can send the following system-generated reports:

  • Trial Summary Report (TSR) – System-generated report that includes a summary of the abstraction in an easy-to-read format.
  • 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 an XML file is required for submission to ClinicalTrials.gov.

The message instructs the submitter to review the TSR for accuracy and to report any changes to the CTRO staff.

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