UPDATED: 3/24/12 (Changes: Added Form B-1 as a pdf on pages: Expedited Review, Forms A-Z, and the Human Repository page. Also replaced the Old Phone Numbers picture with the blue "New IRB and IACP Phone Numbers" picture.)
Form K-2 - VA Data Security Checklist (Vers. 2.17.12)
There is a NEW FORM: Form K-2 For use with New studies involving the VA and any modifications adding the VA as a site. The VA may provide this form to the researcher to fill out and submit with their application to the IRB. Please use the new Form K-2 on your next submission whenever the VA is a site or will be added as a site.
Compliance is required by the STVHCS and the Research Regulatory Programs Office.
There is a New Form B-2. Please use the new Form B-2 on your next submission to the IRB. The new form will require that you ensure each individual on the study has an approved scope of practice if applicable to that individual.
Compliance is required.
Click this link for the FDA Final Rule PPT and press open and then when it is open, press F5.
Compliance is now required.
The new rule requires sponsor's prior aggregate analysis of previously uninformative individual safety reports that were submitted to Investigators and IRBs; FDA Expects the rule to improve the ability of IRBs to focus on important safety issues!
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Subject: NS, Smith (Full Board)
Subject: PR, 01-989H, Smith (Full Board)
Have questions about a form? Wonder which forms to use for your study? Confused about the IRB submission to approval process?
If instructions, guidance and FAQs don't answer your question please give us a call or submit a request for a meeting for one on one help with your IRB application form and email to: IRBmail@uthscsa.edu. Someone from the OIRB will contact you to schedule a consultation.
