Search Instructions:
* Filter the ENTIRE resource library: Choose a OR a to sort all resources.
* Choose Search Items : to filter one collection or perform complex queries.
* Choose Browse by Topic to search by one or more Topics.
Browse Items (30 total)
-
Creator: Abigail E Lowe, Colleen Kraft, Mark G Kortepeter, Keith F Hansen, Kristine Sanger, Ann Johnson, Jonathan D Grein, Julie Martin, Rebecca Rousselle, Jennifer A Garland, Jessica Spotts, John J Lowe, Lauren M Sauer, Christopher J Kratochvil, Bruce G…
Subject: Research
Item Type: Publication
Date Last Updated: 2022-05-31
Description: Research is foundational for evidence-based management of patients. Clinical research, however, takes time to plan, conduct, and disseminate—a luxury that is rarely available during a public health emergency. The University of Nebraska Medical Center… -
Creator: Angela Vasa, Syra Madad, LuAnn Larson, Colleen S. Kraft, Sharon Vanairsdale, Jonathan D. Grein, Jennifer Garland, Virginia “Madison” Butterworth, and Christopher J. Kratochvil.
Subject: Research
Item Type: Publication
Date Last Updated: 2019-02-19
Description: The use of investigational therapeutics in the care of patients with Ebola virus disease was documented in the literature following the 2013-2016 outbreak. In order to access these types of therapeutics, facilities must have processes in place to… -
Creator: Angie M. Boyce and Brian T. Garibaldi.
Subject: Research
Item Type: Publication
Date Last Updated: 2019-02-19
Description: Host genomic research on high-consequence infectious diseases is a growing area, but the ethical, legal, and social implications of such findings related to potential applications of the research have not yet been identified. -
Creator: CITI Program
Subject: Laboratory
Item Type: Hyperlink
Date Last Updated: 2022
Description: The Collaborative Institutional Training Initiative (CITI Program) is dedicated to serving the training needs of colleges and universities, healthcare institutions, technology and research organizations, and governmental agencies, as they foster… -
Creator: Colleen S. Kraft, Mark G. Kortepeter, Bruce Gordon, Lauren M. Sauer, Erica S. Shenoy, Daniel P. Eiras, LuAnn Larson, Jennifer A. Garland, Aneesh K. Mehta, Kevin Barrett, Connie S. Price, Caroline Croyle, Lauren R. West, Brooke Noren, Susan Kline,…
Subject: Research
Item Type: Publication
Date Last Updated: 2019-02-19
Description: The 2013-2016 epidemic of Ebola virus disease (EVD) that originated in West Africa underscored many of the challenges to conducting clinical research during an ongoing infectious disease epidemic, both in the most affected countries of Guinea,… -
Creator: Davis CW, Jackson KJL, McElroy AK, Halfmann P, Huang J, Chennareddy C, Piper AE, Leung Y, Albariño CG, Crozier I, Ellebedy AH, Sidney J, Sette A, Yu T, Nielsen SCA, Goff AJ, Spiropoulou CF, Saphire EO, Cavet G, Kawaoka Y, Mehta AK, Glass PJ, Boyd SD,…
Subject: Research
Item Type: Publication
Date Last Updated: 2019-05-30
Description: Ebola virus (EBOV) remains a public health threat. We performed a longitudinal study of B cell responses to EBOV in four survivors of the 2014 West African outbreak. -
Creator: Editor Bruce Hawkins
Subject: Research
Item Type: Publication
Date Last Updated: 2019
Description: The purpose of these guidelines is to describe a standardized approach for the management of investigational drug products by the clinical research pharmacy, pharmaceutical industry, and cooperative and research network groups. -
Creator: FDA
Subject: Research
Item Type: Hyperlink
Date Last Updated: 2021-05
Description: Guidance for Sponsors, Clinical Investigators, and IRBs. Information for investigational new drugs (IND).
Draft Information Sheet Guidance for Sponsors, Clinical Investigators, and IRBs Frequently Asked Questions Statement of Investigator (Form FDA… -
Creator: FDA
Subject: Research
Item Type: Hyperlink
Date Last Updated: 2022-07-20
Description: Current Federal law requires that a drug be the subject of an approved marketing application before it is transported or distributed across state lines. Because a sponsor will probably want to ship the investigational drug to clinical investigators… -
Creator: FDA
Subject: Research
Item Type: Hyperlink
Date Last Updated: 2023-05-12
Description: The Emergency Use Authorization (EUA) authority allows FDA to help strengthen the nation’s public health protections against chemical, biological, radiological, and nuclear (CBRN) threats including infectious diseases, by facilitating the…
