Please READ:  Approved at the April 19, 2007, IRB meeting, the Board has approved new guidelines for expedited review submissions.  Effectively immediately, expedited review study submissions (new application, renewal, closure, update, and adverse events) no longer need to have accompanying copies.  Only the original with supporting documentation needs to be submitted.  If possible, double-sided copies are appreciated.  If you are unsure of the approval status of your study, this information can be obtained on your original IRB approval letter or contact Kelé Batchelor, IRB Compliance Coordinator at 343.4621.  For new studies, you will be told at the point of initial review of your study.

New Studies

Documents to be submitted (*as required/available):

• Study Application (with signatures)
• Consent Form*
• Protocol*
• Promotional Materials*
• Administrative Attachment

Request for Renewal

Documents to be submitted:

• Annual Renewal Report form.
• Information that has not yet been submitted to the IRB for review (preliminary outcome data, if available, audit reports, etc.)

Closure Report

Documents to be submitted:

• Closure report form.
• Final report/abstract/presentation, etc.

Study Updates/Amendments

Documents to be submitted:

• Update/Amendment Report form.
• Update and/or Amendment
• Consent Form (if changes were required)

Adverse Events/Safety Reports/Safety Information

Documents to be submitted:

• Adverse Event Form.
• Complete copy of the adverse event/safety report and/or safety information.

Documents should be submitted as follows:

• Original copy only
• Complete copy of supporting documentation (i.e. amendments/updates, adverse events, final reports, etc.)

NOTES:

• Use assigned IRB ID# on post-approval form submissions.
• All forms must be typed and have legible signatures or they will be returned.
• Before an application can be submitted to the IRB, the Clinical Research Officer must sign the application giving Administrative Approval.