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Comment: Deleted note now that all sections have checkout as a step.

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The Trial History page displays trial submission, update, and audit trail tabs, from which you can edit submissions, download documents, acknowledge updates, and search audit trails.

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titleNotes About Trial Updates and Trial Amendments
  • Trial updates do not affect any elements that are reflected in the Protocol document. Changes to the Protocol document that require IRB approval are submitted via trial amendments.
  • Trial submitters can update trials any time after the CTRO has accepted their trials. As a result, the Trial History Information Updates tab displays the most recent update, including the description and date of the change.
  • Whenever you reject an amendment during abstraction, the system deletes the amendment information and sends an email message to the submitter that contains the reason for rejection. The Trial History page displays the details of rejected amendments.
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titleCheck out the trial before you begin abstraction

Before you begin, be sure check the trial out for processing. See Checking In and Checking Out Trials.

Reviewing and Editing Trial Submission History

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