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Mental health considerations
Explanation of Risks Be clear in application and ICD about risks associated with mental health a...
IRB Conference Content
2024 2024 IRB Conference Introduction (Bruce Gordon) 2024 IRB Conference Conclusion (Bruce Go...
Investigator Resources
Regulations: Common Rule (45 CFR 46) eCFR: 21 CFR Part 50-Protection of Human Subjects eCFR...
Submission Process
Full Board Review (initial submission) Investigators will be notified of the assigned IRB# by ema...
ClinicalTrials.gov (CT.gov)
Check back to this page for more updates regarding clinicaltrials.gov information. Please conta...
Adverse Event Reporting
Adverse Events (AEs) An Adverse Event is defined by the NIH as: Any untoward or unfavorable medic...
Which application do I use?
There are eight applications to choose from depending on the type of research that is planned. Pl...
Introduction
Mailing Address: Institutional Review Board University of Nebraska Medical Center 98783...
Purpose & Responsibilities
Purpose SPAdmin’s purpose is three-fold: To facilitate a principal investigators’ pursuit and...
Award Set-up
When a notice of award is received, SPAdmin and SPAcctng work with the department to set up the a...
NIH Data Management & Sharing Policy
The National Institutes of Health (NIH) announced a new data management & sharing (DMS) policy to...
Forms, Templates, and Electronic Systems
Internal forms are a means for providing needed information to SPAdmin and SPAcctng and for docum...
NDAA Whistleblower Notice
Pilot Program for Enhancement of Employee Whistleblower Protections In order to encourage employ...
F&A Rates Policy
UNMC Facilities and Administration (F&A) Rates (formerly known as Indirect Cost Rates) The full...
Clinical Research Billing
Clinical Trial Master Matrix The Clinical Trial Master Matrix (CTTM) is a tool that is used to r...
Other Contract Types
In addition to negotiating industry-sponsored research agreements, SPAdmin negotiates many other ...
Confidential Disclosure Agreements (CDAs or NDAs)
Confidential Disclosure Agreements – also known as Non-disclosure Agreements, CDAs or NDAs – prot...
Industry-Sponsored Non-Clinical Research
Industry-sponsored contracts must be reviewed and negotiated before being signed. SPA negotiates ...
Industry Sponsored Clinical Research
Clinical research is defined as research that involves human subjects as participants and/or requ...
Roles & Responsibilities
As soon as you determine interest in a particular project or study, be sure to contact your depar...