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If you import an Expanded Access trial from ClinicalTrials.gov (whether via the Registration or PA web application), the system automatically sets this value to Yes. Otherwise, the default is No. The system does not include this attribute in the TSR, in the XML output to ClinicalTrials.gov, in the trial data sent to Cancer.gov, or in the set of trials provided to the NCI Clinical Trials API.Â
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 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 trial with an IND/IDE, refer to Abstracting INDs and IDEs.