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RSS Guides
Guides to assist with RSS procedures: If there is a topic that does not appear below, please cont...
UNeHealth
UNeHealth is the contracting and fiscal arm for industry-funded clinical trials on behalf of Univ...
Forms, Templates, and Electronic Systems
Internal forms are a means for providing needed information to SPAdmin and SPAcctng and for docum...
2.5 Criteria for IRB Approval
Last Revised: 8/5/2026 For an abbreviated version intended for investigators, coordinators, and s...
3.2 Data and Safety Monitoring
Last Revised 8/19/2026 For an abbreviated version intended for investigators, coordinators, and s...
Sponsor-specific Policies
Federal Uniform Guidance Effective December 26, 2014 the Office of Management and Budget combined...
Staff Listing & Dept Assignments
SPAdmin is under the direction of the Vice Chancellor for Research and is organized as follows: D...
Institutional Information
The following table contains institutional information that is frequently requested by sponsors, ...
Noncompliance
Study teams are responsible for reporting noncompliance to the IRB/ORA. This page serves as a gui...
cIRB - UNMC Process
Note: When requesting cIRB review, study teams must satisfy the requirements of each IRB and the ...
Cheat Sheets & SOPs
Advertisement Policy Cheat Sheet Central IRB (cIRB) Cheat Sheet Coded vs De-Identified Data Compe...
Relevant Links & Resources
Regulations: Common Rule (45 CFR 46) eCFR: 21 CFR Part 50-Protection of Human Subjects eCFR...
6.2 Research Involving Investigational and Marketed Devices
Last Revised: 6/10/2026 For an abbreviated version intended for investigators, coordinators, and ...
2.1 Submission for Items for Review by the IRB
Last Revised: 6/26/2026 1.0 Purpose The purpose of this policy is to describe Organization’s requ...
6.1 Research Involving Investigational and Marketed Drugs
Last Revised: 1/24/2024 For an abbreviated version intended for investigators, coordinators, and ...
1.5 Requirements for Research Conducted with International Sites
Last Revised: 6/10/2026 For an abbreviated version intended for investigators, coordinators, and ...
Subject's Rights & Responsibilities
Research Questions: Amheric - Research Questions & Rights and Responsibilities English (UNMC) Eng...
Recruitment templates
Whenever possible, the layout of advertisements should conform to UNMC's institutional requiremen...
7.2 Collection, Storage and Use of Human Biological Material in Research
Last Revised: 9/24/2025 For an abbreviated version intended for investigators, coordinators, and ...
HRPP Investigator Guidance Series
This page serves as a hub for all of the Investigator Guidance Series documents. Each document is...