What is UPIRTSO?
UPIRTSO stands for Unanticipated Problems that May Involve Risks to Subjects or Others. It refers to problems, in general, to include any incident, experience or outcome which in the opinion of the local investigator was unexpected, at least possibly related to the research procedures and suggests that the research places subjects or others at a greater risk of harm than was previously known or recognized. If a local death is involved, whether related or not, it should be reported to PIEC immediately, within 24 hours after first knowledge by study investigator. All other UPIRTSO should be reported as soon as possible but not later than 7 calendar days after first knowledge by study investigator. Please complete and submit the PIEC UPIRTSO Report Form together with the CIOMS/MedWatch form.
