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240 total results found

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 record basic information about a clinical trial along with protocol specific scheduling of research related procedures/treatments and details on how these procedure...

Roles & Responsibilities

Sponsored Programs Administration Guide... Industry Contracts

As soon as you determine interest in a particular project or study, be sure to contact your department administrator, clinical coordinator if applicable, and the SPAdmin Coordinator. They are familiar with the research infrastructure and administrative require...

Other Contract Types

Sponsored Programs Administration Guide... Industry Contracts

In addition to negotiating industry-sponsored research agreements, SPAdmin negotiates many other types of agreements as a service to faculty investigators. If SPAdmin isn’t authorized to handle a particular agreement, we can direct you to someone who is. A li...

Industry-Sponsored Non-Clinical Research

Sponsored Programs Administration Guide... Industry Contracts

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

Sponsored Programs Administration Guide... Industry Contracts

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)

Sponsored Programs Administration Guide... Industry Contracts

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

Sponsored Programs Administration Guide... Grants

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

Sponsored Programs Administration Guide... Grants

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

Sponsored Programs Administration Guide... Grants

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

Sponsored Programs Administration Guide... Grants

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

Sponsored Programs Administration Guide... Grants

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...

IRB Conference Content

Institutional Review Board (IRB) Guidebook Training

2025 Ethical Study Design IS Good Science (Susan Fish) The AI Middle Game: From Panic to Proportionate IRB Oversight (Tonya Ferraro) Integrating IRB Review Into US Special Pathogens Research Efforts (Kristi DeHaai & Abby Lowe) Informed Consent: Why We ...

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IRB Fees

Institutional Review Board (IRB) Guidebook General Information

In line with most other academic medical centers and universities, the Office of Regulatory Affairs and the IRB charges an initial submission and an annual continuing review fee for commercial and industry sponsored protocols. New Pricing Guidelines (effective...

Transfer Grants

Sponsored Programs Administration Guide... Grants

TRANSFERS IN AND OUT Traditionally sponsors make awards to institutions/organizations and not to an individual therefore special processes are in place to allow for the transfer of a grant whether an investigator is joining UNMC or leaving UNMC. TRANSFERS TO...

Noncompliance

Institutional Review Board (IRB) Guidebook Guides

Study teams are responsible for reporting noncompliance to the IRB/ORA. This page serves as a guide for study teams when deciding what constitutes noncompliance, when it needs to be reported, and how to report it. The following Noncompliance Guide will explain...

New Page

Sponsored Programs Administration Guide...

NIH Common Forms for Biographical Sketch and Current/Pending (Other) Support

Sponsored Programs Administration Guide... Policies

NIH requires the use of Common Forms for Biosketch and Other Support documents for applications due on or after January 25, 2026. The Common Forms will also be required for RPPRs, JITs, and prior approval requests submitted on or after January 25, 2026. Senio...

Downtime Guidance for Data Collection

Institutional Biosafety Committee Guide...

To support studies impacted by an outage, investigators should use the following temporary downtime procedures. If your study uses the impacted service to collect data related to subject safety or to deliver surveys, questionnaires or other data collection ma...