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- The system sends you a submission confirmation letter.
- The CTRO validates the new data and documents you provided, and the system sends you an acceptance (or rejection) message.
- If the amendment is rejected, the system provides the reason for rejection and reinstates your latest verified trial submission.
- If your amendment is accepted, the CTRO abstracts all the trial details.
- When abstraction is complete, the CTRO sends you a Trial Summary Report (TSR) that includes all the newly-modified data in the CTRP. (If appropriate, the CTRO also sends an XML document with all the newly-modified data. XML documents are available for trials that have been designated for import into ClinicalTrials.gov.)
- You review and validate the new TSR and email your approval to the CTRO.
- If you request a change, the CTRO makes corresponding modifications and re-sends the TSR (and XML document, if appropriate).
The amended trial appears in your Search My Trials results list upon acceptance.
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