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Comment: For CTRPMICRO-91, revised based on clarification from Michael Izbicki.

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When a trial has Expanded Access at the trial level in CTRP, the Expanded Access use of the drug/device will most likely require another interventional trial . That trial will have the Expanded Access flag set at the with an IND/IDE level, and it will have the NCT ID of the "parent" trial. For instructions on configuring the separate Expanded Access fields for a the trial with an IND/IDE, refer to Abstracting INDs and IDEs. Consider also specifying each of these trials as an Associated Trial for the other. For instructions, refer to Associating Trials.