Initial; date No No No No No event occurred: Yes Yes Yes Yes Yes; date reported to Insufficient Insufficient Insufficient Date of PI IRB: Info Info Info awareness: 3 Follow-up No No No No No Date(s): Yes Yes Yes Yes Yes; date reported to Insufficient Insufficient Insufficient IRB: Info Info Info Initial; date No No No No No event occurred: Yes Yes Yes Yes Yes; date reported to Insufficient Insufficient Insufficient Date of PI IRB: Info Info Info awareness: 4 Follow-up No No No No No Date(s): Yes Yes Yes Yes Yes; date reported to Insufficient Insufficient Insufficient IRB: Info Info Info Initial; date No No No No No event occurred: Yes Yes Yes Yes Yes; date reported to Insufficient Insufficient Insufficient Date of PI IRB: Info Info Info awareness: 5 Follow-up No No No No No Date(s): Yes Yes Yes Yes Yes; date reported to Insufficient Insufficient Insufficient IRB: Info Info Info Initial; date No No No No No event occurred: Yes Yes Yes Yes Yes; date reported to Insufficient Insufficient Insufficient Date of PI IRB: Info Info Info awareness: 6 Follow-up No No No No No Date(s): Yes Yes Yes Yes Yes; date reported to Insufficient Insufficient Insufficient IRB: Info Info Info The majority of adverse events (AEs) are not UPIRSOs and not all UPIRSOs are AEs. UPIRSOs may also be or caused by deviations, and vice versa. Refer to the Reportable Event policy for HRPP’s more details: . If any questions are or promptly report; follow and report if/when more information becomes available that suggests a UPIRSO. Report non-UPIRSOs at CR. checked “No” “Insufficient info,” do NOT Related means to the research intervention/interaction or to the collection of identifiable private information used in the research. An event/problem/outcome is probably or definitely related if it results in any alteration to the risk-benefit analysis. If the event/problem/outcome is unexpected (e.g., it is not listed in the IB, protocol, or ICD) and probably or definitely related to the research, it almost always warrants changes to protocol and/or IC document/process or other corrective actions in order to inform investigators and subjects of the greater risk of harm.
3 Initial; date event occurred: Date of PI awareness: No Yes Insufficient Info No Yes Insufficient Info No Yes Insufficient Info No Yes No Yes; date reported to IRB: Follow-up Date(s): No Yes Insufficient Info No Yes Insufficient Info No Yes Insufficient Info No Yes No Yes; date reported to IRB: 4 Initial; date event occurred: Date of PI awareness: No Yes Insufficient Info No Yes Insufficient Info No Yes Insufficient Info No Yes No Yes; date reported to IRB: Follow-up Date(s): No Yes Insufficient Info No Yes Insufficient Info No Yes Insufficient Info No Yes No Yes; date reported to IRB: 5 Initial; date event occurred: Date of PI awareness: No Yes Insufficient Info No Yes Insufficient Info No Yes Insufficient Info No Yes No Yes; date reported to IRB: Follow-up Date(s): No Yes Insufficient Info No Yes Insufficient Info No Yes Insufficient Info No Yes No Yes; date reported to IRB: 6 Initial; date event occurred: Date of PI awareness: No Yes Insufficient Info No Yes Insufficient Info No Yes Insufficient Info No Yes No Yes; date reported to IRB: Follow-up Date(s): No Yes Insufficient Info No Yes Insufficient Info No Yes Insufficient Info No Yes No Yes; date reported to IRB: The majority of adverse events (AEs) are not UPIRSOs and not all UPIRSOs are AEs. UPIRSOs may also be or caused by deviations, and vice versa. Refer to the HRPP’s Reportable Event policy for more details: . If any questions are checked “No” or “Insufficient info,” do NOT promptly report; follow and report if/when more information becomes available that suggests a UPIRSO. Report non-UPIRSOs at CR. Related means to the research intervention/interaction or to the collection of identifiable private information used in the research. An event/problem/outcome is probably or definitely related if it results in any alteration to the risk-benefit analysis. If the event/problem/outcome is unexpected (e.g., it is not listed in the IB, protocol, or ICD) and probably or definitely related to the research, it almost always warrants changes to protocol and/or IC document/process or other corrective actions in order to inform investigators and subjects of the greater risk of harm.
event-upirso-tracking-log.docx