What are the Investigators responsibilities related to study management of problems/events that will not meet Mayos IRB definition of UPIRTSO?
• Investigators are reminded that while a problem/event may not initially meet the definition of a UPIRTSO, it can transform (based on nature, severity and frequency) to a UPIRTSO. Therefore, while problems/events may not meet Mayo’s IRB definition of UPIRTSO, continuous monitoring systems are needed to identify in ‘real time’ any changes in nature, severity and/or frequency of problems/events. • Investigators are reminded that Standard Operating Procedures (SOPs) are essential as they set forth: • the documentation/tracking system used by the Investigator for problems/events; and • frequency of study team meetings and/or communication procedures between the Investigator and study team for any changes in nature, severity and/or frequency of problems/events. • Investigators are reminded that while a problem/event may not meet Mayo’s IRB definition of UPIRTSO, they must still comply with requirements for reporting to other reviewing entities (e.g. sponsor, funding agency, DSMB).
Related Questions
- The studys sponsor has sent me an Investigators Brochure (IB) that I need the IRB to acknowledge. What do I need to include when I send it to the IRB office?
- May an IRB require that the sponsor of the study and/or the clinical investigator be identified on the studys consent document?
- How does the IRB review adverse events, other unanticipated problems, and protocol violations?
