Unanticipated Problems

1
Version 1.4 5/12 MAB
Incident, experience, or outcome.
Internal or External AE or SAE
Not an AE or SAE
Do not report individually to IRB Report
to IRB in summary, either in Section 4 of
the Progress Report OR by submitting an
UPSER/Adverse Event form
Unexpected
no
yes
Related or possibly related
Meets the 3 criteria for an Unanticipated
Problem (i.e. stolen laptop with subject
Identities)
no
yes
Greater risk of harm to subjects or others OR
Serious
no
yes
Report to IRB on UPSER/Adverse Event form within
2 business days of investigator becoming aware
of the incident