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.
Amendment to Human Use Protocol |
-Instructions for completing the form and submission of documents required |
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CONSENT- SHORT FORM (Illit).doc |
Use only after IRB approval to add the consent process that utilizes a SHORT FORM consent process for potential subjects or LARs that are unable to see or read English.Instructions for Short Form Consent-Engl Speaking Blind or Illiterate Subject |
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Form A - 1 Multipurpose Signature Assurance Sheet |
Form A-1-Instructions |
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Form E-2 - Spanish Repository Consent |
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Form E-3 - VA Spanish Repository Consent (Under Construction) |
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Form H - For recruitment of Non-English/Non-Spanish speaking subjects, attach translated consent document (This is not a template. This represents the location of the translated consent in the completed submission package.) |
(Info pertaining to subjects from a foreign culture) Form H-Instructions |
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Form H-1 - Translation Certification Form (turned in with translated consent form) |
(Pertains to subjects from any foreign culture) Form H-1-Instructions |
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HDE Progress Report Form |
HDE Progress Report Form-Instructions |
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Instructions for Short Form Consent-non-Engl Speaking Subject-no translation.doc |
Used with CONSENT-SHORT FORM |
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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. |
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Progress Report Form |
Progress Report Form-Instructions |
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Protocol Deviations Tracking Log |
Click here for-Instructions |
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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 |
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Repository Progress Report Form |
Repository Progress Report Form-Instructions |
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Request for Inactivation (Formerly "Final Report") |
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Tracking Log for Events and Problems (Track both UPIRSO and Events and Problems Not Requiring Prompt Reporting) |
Option form. For use when no pre-existing tracking system capable of producing reports is available. |
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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 |
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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 |
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