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Browse Items (12 total)
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- 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.
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- 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…
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- 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:
- Nathan L. Yozwiak, Christian T. Happi, Donald S. Grant, John S. Schieffelin, Robert F. Garry, Pardis C. Sabeti, and Kristian G. Andersen, on behalf of the Viral Hemorrhagic Fever Consortium and the African Center of Excellence for Genomics of…
- Subject:
- Emergency Management
- Item Type:
- Publication
- Date Last Updated:
- 2016-06-30
- Description:
- Summary
Recent infectious disease epidemics illustrate how health systems failures anywhere can create disease vulnerabilities everywhere. We must therefore prioritize investments in health care infrastructure in outbreak-prone regions of the…
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- Creator:
- WHO
- Subject:
- Infection Control
- Item Type:
- Publication
- Date Last Updated:
- 2019-04-12
- Description:
- ABOUT THIS ANALYSIS: DRC’s national research institute, the Institut National pour la Recherche Biomedicale (INRB) and WHO have conducted a preliminary analysis of the data being collected from the ring vaccination protocol. The analysis summarized…
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- Creator:
- NETEC SPRN Medical Countermeasures Working Group
- Subject:
- Research
- Item Type:
- Publication
- Date Last Updated:
- 2019-02-19
- Description:
- Emerging and re-emerging infectious diseases pose growing global public health threats. However, research on and development of medical countermeasures (MCMs) for such pathogens is limited by the sporadic and unpredictable nature of outbreaks, lack…
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- 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,…
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- Creator:
- NETEC
- Subject:
- Research
- Item Type:
- Online Course
- Date Last Updated:
- 2018-11-06
- Description:
- This course will provide information on many aspects of clinical research. This includes scientific process, research protocol, documentation, regulatory documents, adverse event classification, and reporting events to regulatory bodies. Record…
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- Creator:
- University of Minnesota, Center for Infectious Disease Research and Policy
- Subject:
- Treatment & Care
- Item Type:
- Publication
- Date Last Updated:
- 2017-01-17
- Description:
- In the third major report from the Wellcome Trust–CIDRAP Ebola Vaccine Team B reflects on progress to date and the remaining challenges faced.
-
- Creator:
- National Academies Press
- Subject:
- Research
- Item Type:
- Publication
- Date Last Updated:
- 2017-04-12
- Description:
- Table of Contents Front Matter i-xxvi Summary 1-18 1 Introduction 19-36 2 Conducting Clinical Research During an Epidemic 37-82 3 Assessment of Therapeutic Trials 83-112 4 Assessment of Vaccine Trials 113-154 5…
