 |
|
|
|
 |
 |
 |
|
UPIRSOs Timelines
For research being conducted at UIC
- Unanticipated Problems Involving Risks to Subjects or Others (UPIRSOs)
Submit report within 7 working days of discovery of the event to OPRS using the Event Requiring Prompt Reporting to the IRB form
- Subject death that is unexpected and related or possibly related to the research
Report within 24 hours of discovery of the event to OPRS at 312-413-4799
Submit a written report within 7 working days following the telephone report to OPRS using the Event Requiring Prompt Reporting to the IRB form
- Major violation/deviation
Submit a written report within 5 working days of discovery of the event to OPRS using the Event Requiring Prompt Reporting to the IRB form
For research conducted at the JBVAMC, investigators should continue to follow the VA reporting requirements:
- Serious adverse events (regardless of whether unexpected or related), unanticipated adverse events (regardless of relationship) and other unanticipated problems
Report within 7 days of discovery of the event
Obtain signatures of both the JBVAMC PI and the UIC PI (if different)
Submit 1 copy of the Event Requiring Prompt Reporting to the IRB form to the JBVAMC R&D Office and 1 copy to the UIC OPRS
- JBVAMC Subject Death (regardless of whether unexpected or related)
Report within 24 hours of discovery of the event to OPRS at 312-413-4799
Submit a written report within 7 working days following the telephone report to OPRS and the JBVAMC R&D Office using the Event Requiring Prompt Reporting to the IRB form
- Major violation or deviation
Submit report within 5 working days of discovery of the event to OPRS using the Event Requiring Prompt Reporting to the IRB form
 |
|