Procedures
The IRB is committed to making the submission process as smooth as possible. In this section, you will find definitions, explanations and procedures for submitting an application and any other form that may be required during the course of a study.
If you have any questions, please contact us at irbora@unmc.edu
Adverse Event Reporting
Adverse Events (AEs) An Adverse Event is defined by the NIH as: Any untoward or unfavorable medi...
ClinicalTrials.gov (CT.gov)
Check back to this page for more updates regarding clinicaltrials.gov information. Please co...
Emergency Treatment
The contact list for Emergency Treatment authorization can be found here in RSS. Under certain c...
Exempt Studies
It is understood this project will be conducted in full accordance with all applicable HRPP Polic...
Incidents (Non-compliance/Problems)
Per HRPP policy 8.4 non-compliance (NC) involving the PI and/or study personnel must be promptly ...
Protocol Deviations
A Single Subject Protocol deviation is a change in an IRB-approved protocol which is permitted fo...
Submission Process
Full Board Review (initial submission) Investigators will be notified of the assigned IRB# by em...