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Information pertaining to Human Subject Research, Institutional Review Board, and the Office of Regulatory Affairs is no longer updated in this handbook. Visit the IRB Guidebook for the most up-to-date information. Training-related content can be found withi...

Information pertaining to Human Subject Research, Institutional Review Board, and the Office of Regulatory Affairs is no longer updated in this handbook. Visit the IRB Guidebook for the most up-to-date information.

Information pertaining to Human Subject Research, Institutional Review Board, and the Office of Regulatory Affairs is no longer updated in this handbook. Visit the IRB Guidebook for the most up-to-date information.   Content related to developing a clinical...

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...