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11/07/08: The Internal Adverse Event forms (Serious/Unexpected and Fatal or Life-Threatening) have been revised to reflect an administrative change. There is no change to the portion of the form to be filled out by investigators. However, please use these updated versions when submitting adverse events.
4/17/08: The amendment submission form has been revised as noted in the email to IRB contacts dated 4/9/08 and 4/17/08. This form version is dated April 2008 and is effective immediately. The amendment form version dated APRIL 2007 will only be accepted for amendment submissions through April 22, 2008.
1/10/08: Supplemental form H has been revised to reflect updated language from the RADRAC. This form version is dated December 2007 and is effective immediately.
11/29/07: Supplemental form G has been revised to reflect a change in the requirements for submission of this form as outlined in the email sent to IRB contacts on 11/29/07. This form version is dated October 2007 and is effective for deadlines beginning in January 2008.
IRB Submissions
Forms and Guidelines
External Resources
Office for Human Research Protections (OHRP)
Food and Drug Administration (FDA)
Internal Resources
Office of Clinical Research (OCR)
University Research Administration (URA)
Office of Research Services (ORS)
HIPAA Program Office
Institutional Biosafety Committee (IBC)
Radioisotopes and Radioactive Drugs (RADRAC)
General Clinical Research Center (CRC)
Institutional Review Board © 2008 |