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Investigator Resources

Institutional Review Board (IRB) Guidebook Education & Resources

Regulations: Common Rule (45 CFR 46) eCFR: 21 CFR Part 50-Protection of Human Subjects eCFR...

Updated 3 days ago by James Geiger

Submission Process

Institutional Review Board (IRB) Guidebook Procedures

Full Board Review (initial submission) Investigators will be notified of the assigned IRB# by ema...

Updated 3 days ago by James Geiger

ClinicalTrials.gov (CT.gov)

Institutional Review Board (IRB) Guidebook Procedures

Check back to this page for more updates regarding clinicaltrials.gov information. Please conta...

Updated 3 days ago by James Geiger

Adverse Event Reporting

Institutional Review Board (IRB) Guidebook Procedures

Adverse Events (AEs) An Adverse Event is defined by the NIH as: Any untoward or unfavorable medic...

Updated 3 days ago by James Geiger

Which application do I use?

Institutional Review Board (IRB) Guidebook

There are eight applications to choose from depending on the type of research that is planned. Pl...

Updated 3 days ago by James Geiger

Report a research problem or complaint

Institutional Review Board (IRB) Guidebook

Report a problem Report a problem securely and confidentially through the UNMC Human Subjects Res...

Updated 3 days ago by James Geiger

Introduction

Institutional Review Board (IRB) Guidebook

Mailing Address: Institutional Review Board University of Nebraska Medical Center 98783...

Updated 3 days ago by James Geiger

IRB News & Updates

Institutional Review Board (IRB) Guidebook

HRPP Update 6/12/2025 - Policy 1.4 revised HRPP Updates 5/15/2025 - HRPP 1.4 revised 5/5/2025 - H...

Updated 3 days ago by James Geiger

Training

Sponsored Programs Administration Guide...

SPAdmin offers a number of formal and informal educational opportunities for departmental adminis...

Updated 1 week ago by Lori A Stewart

Purpose & Responsibilities

Sponsored Programs Administration Guide... About Us

Purpose SPAdmin’s purpose is three-fold: To facilitate a principal investigators’ pursuit and...

Updated 1 week ago by James Geiger

Award Set-up

Sponsored Programs Administration Guide... Grants

When a notice of award is received, SPAdmin and SPAcctng work with the department to set up the a...

Updated 1 week ago by James Geiger

NIH Data Management & Sharing Policy

Sponsored Programs Administration Guide... Policies

The National Institutes of Health (NIH) announced a new data management & sharing (DMS) policy to...

Updated 1 week ago by James Geiger

Forms, Templates, and Electronic Systems

Sponsored Programs Administration Guide...

Internal forms are a means for providing needed information to SPAdmin and SPAcctng and for docum...

Updated 1 week ago by James Geiger

NDAA Whistleblower Notice

Sponsored Programs Administration Guide... Policies

Pilot Program for Enhancement of Employee Whistleblower Protections In order to encourage employ...

Updated 1 week ago by James Geiger

F&A Rates Policy

Sponsored Programs Administration Guide... Policies

UNMC Facilities and Administration (F&A) Rates (formerly known as Indirect Cost Rates) The full...

Updated 1 week ago by James Geiger

Clinical Research Billing

Sponsored Programs Administration Guide... Clinical Trials

Clinical Trial Master Matrix The Clinical Trial Master Matrix (CTTM) is a tool that is used to r...

Updated 1 week ago by James Geiger

UNeHealth

Sponsored Programs Administration Guide... Clinical Trials

UNeHealth is the contracting and fiscal arm for industry-funded clinical trials on behalf of Univ...

Updated 1 week ago by James Geiger

Other Contract Types

Sponsored Programs Administration Guide... Industry Contracts

In addition to negotiating industry-sponsored research agreements, SPAdmin negotiates many other ...

Updated 1 week ago by James Geiger

Confidential Disclosure Agreements (CDAs or NDAs)

Sponsored Programs Administration Guide... Industry Contracts

Confidential Disclosure Agreements – also known as Non-disclosure Agreements, CDAs or NDAs – prot...

Updated 1 week ago by James Geiger

Industry-Sponsored Non-Clinical Research

Sponsored Programs Administration Guide... Industry Contracts

Industry-sponsored contracts must be reviewed and negotiated before being signed. SPA negotiates ...

Updated 1 week ago by James Geiger