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States

Understanding eCTD States: Managing File and Section Status for Regulatory Submissions

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Written by Alondra Sandoval

States are assigned by an internal user to file references, sections, sequences, and regulatory activities to prevent changes to sections that have already been reviewed internally or submitted to a regulatory authority.

States reflect the overall status and set the states of files and sections contained within them to prevent accidental editing. If editing of secured sections is needed, their states must be changed back to In Progress from whatever states they are in.

Please see the “Manage States” section for additional details on how to assign states to sequences, regulatory activities, and file references.

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