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Existing paper protocols
NOTE: THE PAPER FORMS ON THIS PAGE ARE ONLY TO BE USED FOR STUDIES THAT HAVE NOT BEEN TRANSFERRED...
cIRB - UNMC Process
Note: When requesting cIRB review, study teams must satisfy the requirements of each IRB and the ...
cIRB - What is Central IRB?
The UNMC IRB uses the term “central IRB” or “cIRB” to indicate that the reviewing IRB (i.e., the ...
sIRB - Fees
For information regarding the fee schedule for Single IRB studies, please contact sirb@unmc.edu.
sIRB - Reliance
Reliance refers to an arrangement where an IRB allows another IRB to perform review and approval ...
sIRB - UNMC process
The UNMC sIRB Process is captured in the diagram below. Contact sirb@unmc.edu with any UNMC sI...
sIRB - What is Single IRB?
Single IRB is a model of IRB review that is intended to streamline and reduce administrative burd...
Recruitment templates
HRPP policy to review: #3.5 Subject Recruitment Through Advertisements Recruitment Type Format ...
Community Partners
All individuals that work on human subject research projects must complete human subject research...
Investigator Resources
Regulations: Common Rule (45 CFR 46) eCFR: 21 CFR Part 50-Protection of Human Subjects eCFR: 2...
Glossary
Cede Review An institution agrees to transfer IRB review and oversight authority for specified r...
Submission Process
Full Board Review (initial submission) Investigators will be notified of the assigned IRB# by em...
Emergency Treatment
The contact list for Emergency Treatment authorization can be found here in RSS. Under certain c...
Adverse Event Reporting
Adverse Events (AEs) An Adverse Event is defined by the NIH as: Any untoward or unfavorable medi...
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...
ClinicalTrials.gov (CT.gov)
Check back to this page for more updates regarding clinicaltrials.gov information. Please co...
Exempt Studies
It is understood this project will be conducted in full accordance with all applicable HRPP Polic...
CITI Training
What is CITI? Collaborative Institutional Training Initiative (CITI) certification is an insti...
Funding
Announcements Internal & External Funding Upcoming internal funding announcements are share...