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Comment: For CTRPMICRO-349 & 368, revised based on response from Michael Izbicki in JIRA.

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  1. The system sends you a submission confirmation letter.
  2. The CTRO validates the new data and documents you provided, and the system sends you an acceptance (or rejection) message.
    1. If the amendment is rejected, the system provides the reason for rejection and reinstates your latest verified trial submission.
    2. If your amendment is accepted, the CTRO abstracts all the trial details.
  3. 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.)
  4. You review and validate the new TSR and email your approval to the CTRO.
  5. 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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