PDF
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Type of Report
Adverse device effect (Report only if unanticipated.)
Adverse event or injury (Report only if serious, unexpected, and related.)
Breach of confidentiality
Data and Safety Monitoring Board (DSMB) report, interim analysis, or other oversight committee/monitoring report
Investigator’s brochure update
New information (Report information…
https://www.wichita.edu/research/IRB/_documents/IRB-Event-Reporting.pdf