UTHSCSA - Institutional Review Board- Form Required after Approval

Forms Required

after Approval

Note: 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.

Also referenced through a hyperlink in the progress report form, Progress Report Form Instructions are available by clicking here.

Progress Report Form	Progress Report Form Instructions
HDE Progress Report Form	HDE Progress Report Form Instructions
Repository Progress Report Form	Repository Progress Report Form Instructions
Amendment to Human Use Protocol	Amendment Checklist
UPIRSO Reporting Form / Adverse Event	(Use AE form if event resulted in physical or psychological harm) Click this link for Help Determining whether an AE is an Unanticipated problem
UPIRSO Reporting Form / Non-Adverse Event	(Use Non-AE form where no physical or psychological harm resulted whether medical or nonmedical event) Click here for Help Determining whether a non_AE is an Unanticipated problem
Tracking Log for Events and Problems Not Requiring Prompt Reporting	Option form. For use when no pre-existing tracking system capable of producing reports is available.
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.
Report of Noncompliance	Used to self report noncompliance with federal regulations or IRB Policies as well as major deviations. Click here for Instructions for completing the Report of NonCompliance
Request for Inactivation (Formerly "Final Report")	Instructions

UTHSCSA © 2006 | Privacy Policy | Last revision 12/12/2007 | VPR WebMaster
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