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Industry-Sponsored Non-Clinical Research
Industry-sponsored contracts must be reviewed and negotiated before being signed. SPA negotiates non-clinical and clinical research agreements with the exception of Phase I-IV Clinical Trial Agreements negotiated by UNeHealth. Non-clinical research Non-clini...
Industry Sponsored Clinical Research
Clinical research is defined as research that involves human subjects as participants and/or requires the informed consent of a human subject. In addition to clinical trials, clinical research encompasses physiologic studies as well as any projects involving h...
Confidential Disclosure Agreements (CDAs or NDAs)
Confidential Disclosure Agreements – also known as Non-disclosure Agreements, CDAs or NDAs – protect confidential information shared between a sponsor and investigator as they determine mutual interest in working together. The information may belong to the inv...
Pre-Award Guidelines
SPAdmin can assist you with many aspects of developing and submitting a proposal. Once you identify a funding opportunity to which you intend to apply, please notify SPAdmin so that we can prepare to answer any questions you may have, discuss any special cons...
Just In Time
Just in Time refers to the period after application submission and peer review and before selection for funding. During this period, the sponsor may request additional information that was not required to be submitted with the application. Just in Time balan...
Award Set-up
When a notice of award is received, SPAdmin and SPAcctng work with the department to set up the award in UNMC’s sponsored program systems. The information below will guide you through the award set-up process, unique terminology, and issues that impact award ...
Post Award Guidelines
Reporting Requirements Technical The PI is responsible for preparing the technical report. Either the PI or SPAdmin can be responsible for submitting the report, either via an electronic system and/or in paper. SPAdmin’s review of a technical report is foc...
Award Close-Out
After the funded project is complete, UNMC must administratively close out the project with the sponsor and internally. Technical Reporting In general, a final technical report should include: Summary of progress made toward the achievement of the origina...
Table of Contents
Introduction IRB News & Updates FAQ HRPP Manual Does my project require IRB review? Which application do I use? Submission Deadlines Report a research problem or complaint Procedures Adverse Event Reporting Clinicaltrials.gov Emergency Treatment Exempt...
IRB Conference Content
2024 2024 IRB Conference Introduction (Bruce Gordon) 2024 IRB Conference Conclusion (Bruce Gordon) Big Data and Ethics (Scott Campbell) Considerations for Patient Safety in Studies of Psychedelics and other Non-Ordinary States of Consciousness. (Lou Lu...