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Introduction All research conducted at another site, including in another country, must comply with all applicable federal and state laws and University of Nebraska policies. We have developed a questionnaire to help you prepare for research performed in coll...

Technology transfer Technology transfer is the transfer of knowledge and discoveries to the public. It can occur through publications, educated students entering the workforce, exchanges at conferences, and relationships with industry, among other things. For...

Required Human Subjects Protection Training All research personnel planning to conduct human subject research are required to complete Web-based training on human subject protection and good clinical practice (GCP) on the Collaborative Institutional Training ...

Introduction The UNMC Institutional Review Board (IRB) reviews all human subject protocols conducted by anyone on the premises of UNMC, Nebraska Medicine, Children’s Hospital & Medical Center, Nebraska Medicine - Bellevue, and the University of Nebraska a...

Considerations for Preparing a Budget For studies that require a grant or contract, the Investigator or representative is responsible for generating and/or negotiating the budget with the sponsor. Initiation costs and Personnel time for start-up Determinati...

Introduction UNMC has developed many resources for clinical and translational research through the Center for Clinical and Translational Research (CCTR) as well as partnerships with other collaborators. Center for Clinical and Translational Research (CCTR) ...

Data Safety Monitoring All human subject research should have an appropriate data safety monitoring plan to ensure subject safety regarding the risks, complexity, and nature of the research. Appropriate monitoring may include a data safety monitoring plan, as...

ClinicalTrials.gov Registry Required Registration Registration is required for trials that meet the FDAAA 801 definition of an "applicable clinical trial" that include the following: Trials of drugs and biologics. Controlled clinical investigations, other...

Introduction The oncology Clinical Trials Office (CTO) provides central management and oversight functions for all cancer-related trials that involve human subjects conducted on campus. The CTO is staffed by project coordinators, research nurse coordinators, ...

Introduction All clinical trials that use an approved drug or investigational product supplied to the institution from a sponsor must have the protocol reviewed by the Medical Staff Pharmacy and Therapeutics Committee (P&T Committee). P&T Committee F...

Special Considerations As the sponsor of a multi-center trial, additional considerations may be necessary, including the following: Choosing sites for the trial and ensuring that the sites: have the needed patient population conduct a feasibility assessm...

Training Requirements Federal regulations require institutions to provide training in the humane practice of animal care and use, and in instruction in research and testing methods that minimize the number of animals required to obtain valid results and to mi...

Key Contacts The Office of Regulatory Affairs (ORA) answers all questions and assists with the IACUC submission process. Web: unmc.edu/iacuc Phone: 402-559-6046 Email: iacucora@unmc.edu Research Requiring IACUC Approval Prior to project initiation, every...

Pricing Information Current pricing for Comparative Medicine charges can be found on the Comparative Medicine Pricing page. Ordering Animals Comparative Medicine uses a Web-interfaced system, the Comparative Medicine Business Management System (CMMS), for a...

Available Facilities Comparative Medicine operates seven animal housing and/or support facilities. All facilities for housing animals are registered research facilities under the Animal Welfare Act and are inspected regularly by the United States Department ...

Research Service Centers/Core Facilities To assist researchers in basic, translational and clinical research, UNMC provides extensive Core Facilities on campus. A directory of core facilities/service centers has been made available. In addition to institutio...

Radiologic Images for Research Studies Can the institution upload radiology images electronically to send to a central lab? Yes. Who is responsible for uploading radiology images that I have to send to a central lab? Research coordinators and other study s...

Getting Started Who can help me with industry-sponsored clinical trials? Your department administrator and the UNeHealth Contracts Office Associate should be notified as soon as you identify a study in which you plan to participate. Web: unmc.edu/spa/clinic...

Who can help me with industry-sponsored research? Your department administrator and the SPAdmin Contracts Associate should be notified as soon as you identify a study in which you plan to participate. Web: unmc.edu/spa/contracts/non-clinical Phone: 402-559-...

1.0 Purpose The purpose of this policy and procedure is to provide a basic description of the Organization’s Human Research Protection Program (HRPP) through: 1) the Organization’s stated mission, 2) application of ethical principles to guide all human subjec...