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Updated IDE (markdown)

calexh-sar 2021-04-20 15:38:59 -04:00
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IDE.md

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### Protocol Builder Interface
This workflow does not rely on data from PB.
If Coordinators specify in PB an Investigational Device is used in the study, the IRB API Details variable IS_IDE is set to 1 (true). If true, PB provides fields to enter the IDE #, if available, which is stored in the IRB API Details variable IDE. The Coordinator is also asked if the device was developed at UVA, and if so, the IRB API Details variable IS_UVA_IDE is set to 1 (true).
### CRC1 Stats
This workflow does not have any CRC1 stats.