Frequently Asked Questions

Reportable Events

UPIRSOs (AE, SAE, and non-AE reporting)

What is a UPIRSO? 
What is meant by “others” in the term “Unanticipated Problems Involving Risks to Subjects or Others?”  
Should AEs, SAEs, safety reports (e.g., SUSAR, MedWatch), and investigator letters be promptly reported via a RE? 
How do I know or determine if an event is unexpected? 
I received a SUSAR report on an external subject’s SAE. The subject’s PI assessed the event as probably related to the study drug, but the sponsor did not agree. What now? 
What if the sponsor’s comment, assessment, or conclusion in the SUSAR or MedWatch states the study product “cannot be completely excluded” as a cause of the event? 
What if there’s not enough information to determine whether an event is unexpected, probably or definitely related, or increases the risks of the research? 
What if the event does not result in any changes to the study or other corrective actions such as notifying subjects? What if the sponsor states they will “continue to monitor” the SAE? 
What if an event is not a UPIRSO, but the sponsor is requiring it to be submitted to the UTSW IRB (or UTSW HRPP for reliance studies)? 


What is noncompliance? 
When can changes be made to IRB-approved research without prior IRB approval? 
What if a change was made without prior IRB approval that was not an emergency deviation (i.e., the change was not made to eliminate an apparent immediate hazard or to protect the life or physical well-being of subjects in an emergency)? 
The subject signed an expired ICF or the ICF without the IRB approval stamp. Should this be promptly reported via a RE?  
Is subject noncompliance (e.g., missing or incomplete diaries; missed or out-of-window study visits; missed study drug doses, etc.) promptly reportable to the UTSW IRB (or UTSW HRPP for reliance studies) via a RE? 
What does it mean to “violate a subject’s rights?” 
Who is notified when the IRB determines an event is serious and/or continuing noncompliance? 

Root Cause Analyses & Corrective and Preventive Action (CAPA) Plans

What is a “root cause” analysis? How do I determine root causes? 
What is a Corrective And Preventive Action (CAPA) plan?  


Do I have to take Human Subject Protection training?  
I have taken CITI at my former institution, do I need to retake it at UT Southwestern? 
How often must I complete CITI training? 
How long does the training take? 
Can I complete CITI training in several sessions? 
What if I have a certificate from another training program? 
Where do I send my training certificates of completion?  
Can I take additional modules beyond the above courses? 
The grants officer requires a statement of the research training I have taken. Where can I get such a letter?  


How do I submit an amendment for a reliance study? 
How do I submit a continuing review for a reliance study?  
How do I add a non-English short form for a reliance study? 
How do I change the PI for a reliance study? 
Who decides which IRB reviews? 
What is the timeframe for acceptance of the review of the IRB of record?  
An unanticipated problem (e.g., adverse event) or noncompliance occurred on my study locally. Who do I report it to?