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• It will depend on the event. The reporting requirements for both sponsor and the IRB should be spelled out in the protocol. There may be times when events occur that need to be reported to the sponsor but not to the IRB.
  
  
• The most common source of confusion is related to the reporting of Serious Adverse Events (SAEs) or Serious Suspected Adverse Reactions (SUSARs) and Unanticipated Problems (UPs). For example, SAEs will require reporting to the sponsor, but the SAE may not meet criteria for reporting to the IRB (e.g., the SAE is unrelated to the research and, as such, is not a UP.) These terms are not interchangeable, and the definitions of each should be reviewed at the time of reporting to make sure the event is reported to the appropriate entity. See Policy 801, Reporting Research Events for additional information.
  
  
• See the following for additional information regarding reporting safety information:
  • FDA Guidance for Clinical Investigators, Sponsors, and IRBs Adverse Event Reporting to IRBs — Improving Human Subject Protection
  • OHSRP website IND Safety Report Submissions FAQs

What are my responsibilities for maintaining records when my FDA regulated research protocol involves drugs?

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