Upon trial abstraction validation or abstraction update, you can send a trial summary report that includes the summary of the abstraction and an XML file that contains abstracted trial records formatted for submission to ClinicalTrials.gov.
Attached to the message are two system-generated reports as follows:
- Trial Summary Report (TSR) – System-generated report that presents all abstracted data 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.
