Page 442 - eBook Version 8 Book 1 of 2 JUL 2022

STANDARD OPERATING PROCEDURE Research Administration SOP No: R-Rec-107 SOP Title: Reportable Events
Other Research-Related Incidents to be report to the IRB:
Use the table below to determine what other research-related information requires prompt reporting to the IRB and the timelines required for reporting.
The following should not be promptly reported to the IRB. Instead, they should be summarized and submitted to the IRB at the next continuing review:
• DSMB/DMC/DSC reports, unless they meet the UPIRSO criteria.
• Adverse events or other problems that are expected and/or not related or
possibly related to the research.
• Individual study sponsor IND/IDE safety reports; external, internal, or routine audit and monitoring reports; protocol deviations; minor complaints, or other reports, unless they meet the UPIRSO criteria or contain findings of noncompliance that are either serious or continuing.
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