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What if an unanticipated problem is determined by the researcher not to meet the criteria for UPIRTSO?

April 26, 2017criteria meet problem researcher unanticipated upirtso

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What if an unanticipated problem is determined by the researcher not to meet the criteria for UPIRTSO?

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All problems/events that do not meet the IRB’s definition of UPIRTSO should be reported to the IRB in summary form (using a table or spreadsheet) at the time of continuing review. Accompanying documentation (sponsor report forms, etc.) should not be included with this summary and if received will be returned to the researcher.