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Special Focus Area: UPIRSO - Unanticipated Problems Involving Risk to Subjects or Others

ExampleNote:  These forms are best downloaded using Internet Explorer (IE) as your web browser but then click "Save" because they are best opened in Microsoft Word from after being saved to your computer (Click the picture for an example).  If you are experiencing problems downloading a form from our page, and using an alternate browser has not helped (i.e., Netscape Navigator, Internet Explorer), please call the Office of the IRB at 210-567-2351.

Instructions:

Always return to this webpage to create new submissions for continuing review, amendments, reports of possible UPIRSO, etc. to ensure you are using the most current forms.

Amendment to Human Use Protocol

Amendment Instructions [HTML]
Tracking Log for Events and Problems Not Requiring Prompt Reporting

Tracking log Instructions[HTML]

UPIRSO Reporting Form / Adverse Event (Resuled in physical or psychological harm)

(Use AE form if event resulted in physical or psychological harm

UPIRSO Reporting Form / Non-Adverse Event (Medical or nonmedical but no physical or psychological harm resulted)

(Use Non-AE form where no physical or psychological harm resulted whether medical or nonmedical event)

Notification of Adverse Device Effect - Possible UADE

Used to report Unanticipated Adverse Device Effects (UADE) not meeting criteria as UPIRSO (Otherwise report on UPIRSO form) Typically this is the case when an adverse device effect is not unexpected when considering the subjects underlying condition or known circumstances (does not meet UPIRSO criteria) but is unexpected based on protocol documents and meets other criteria as a UADE.
UPIRSO Policy

 

 
 

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