ASHP Guidelines for the Management of Investigational Drug Products
<a href="/items/browse?advanced%5B0%5D%5Belement_id%5D=49&advanced%5B0%5D%5Btype%5D=is+exactly&advanced%5B0%5D%5Bterms%5D=Research">Research</a>
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.
<a href="/items/browse?advanced%5B0%5D%5Belement_id%5D=39&advanced%5B0%5D%5Btype%5D=is+exactly&advanced%5B0%5D%5Bterms%5D=Editor+Bruce+Hawkins">Editor Bruce Hawkins</a>
2019
2024-03-28 by J. Mundy – not yet reviewed asset – bumping first review 1 year
Y - D0.1Res/D0.2Res Qualtrics # 1307, original # 5
2024-08-11
Frequently Asked Questions – Statement of Investigator (Form FDA 1572)
<a href="/items/browse?advanced%5B0%5D%5Belement_id%5D=49&advanced%5B0%5D%5Btype%5D=is+exactly&advanced%5B0%5D%5Bterms%5D=Research">Research</a>
Guidance for Sponsors, Clinical Investigators, and IRBs. Information for investigational new drugs (IND).
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2010-06
2024-03-28 by J. Mundy – not yet reviewed asset – bumping first review 1 year
Y - D0.1Res/D0.2Res Qualtrics # 1301, original # 2
Y - D0.1Res/D0.2Res Qualtrics # 1302, original # 2a
Y - D0.1Res/D0.2Res Qualtrics # 1303, original # 2b
2024-08-11
Developing a Rapid Response Single IRB Model for Conducting Research During a Public Health Emergency
<a href="/items/browse?advanced%5B0%5D%5Belement_id%5D=49&advanced%5B0%5D%5Btype%5D=is+exactly&advanced%5B0%5D%5Bterms%5D=Research">Research</a>
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 (UNMC) developed a single institutional review board (IRB), with a vision to establish a rapid review resource for a network focused on clinical research of emerging pathogens in the United States.
<a href="/items/browse?advanced%5B0%5D%5Belement_id%5D=39&advanced%5B0%5D%5Btype%5D=is+exactly&advanced%5B0%5D%5Bterms%5D=Abigail+E+Lowe%2C%C2%A0Colleen+Kraft%2C%C2%A0Mark+G+Kortepeter%2C%C2%A0Keith+F+Hansen%2C%C2%A0Kristine+Sanger%2C%C2%A0Ann+Johnson%2C%C2%A0Jonathan+D+Grein%2C%C2%A0Julie+Martin%2C%C2%A0Rebecca+Rousselle%2C%C2%A0Jennifer+A+Garland%2C%C2%A0Jessica+Spotts%2C%C2%A0John+J+Lowe%2C%C2%A0Lauren+M+Sauer%2C%C2%A0Christopher+J+Kratochvil%2C%C2%A0Bruce+G+Gordon">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 Gordon</a>
2022-05-31
2024-03-28 by J. Mundy – not yet reviewed asset – bumping first review 1 year
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2024-07-25
A minimal common outcome measure set for COVID-19 clinical research
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Clinical research is necessary for an effective response to an emerging infectious disease outbreak. However, research efforts are often hastily organised and done using various research tools, with the result that pooling data across studies is challenging.
<a href="/items/browse?advanced%5B0%5D%5Belement_id%5D=39&advanced%5B0%5D%5Btype%5D=is+exactly&advanced%5B0%5D%5Bterms%5D=Marshall%2C+John+C.%2C+Srinivas+Murthy%2C+Janet+Diaz%2C+Neil+Adhikari%2C+Derek+C.+Angus%2C+Yaseen+M.+Arabi%2C+Kenneth+Baillie%2C+Michael+Bauer%2C+Scott+Berry%2C+Bronagh+Blackwood%2C+Marc+Bonten%2C+Fernando+Bozza%2C+Frank+Brunkhorst%2C+Allen+Cheng%2C+Mike+Clarke%2C+Vu+Quoc+Dat%2C+Menno+de+Jong%2C+Justin+Denholm%2C+Lennie+Derde%2C+Jake+Dunning%2C+Xiaobin+Feng%2C+Tom+Fletcher%2C+Nadine+Foster%2C+Rob+Fowler%2C+Nina+Gobat%2C+Charles+Gomersall%2C+Anthony+Gordon%2C+Thomas+Glueck%2C+Michael+Harhay%2C+Carol+Hodgson%2C+Peter+Horby%2C+YaeJean+Kim%2C+Richard+Kojan%2C+Bharath+Kumar%2C+John+Laffey%2C+Denis+Malvey%2C+Ignacio+Martin-Loeches%2C+Colin+McArthur%2C+Danny+McAuley%2C+Stephen+McBride%2C+Shay+McGuinness%2C+Laura+Merson%2C+Susan+Morpeth%2C+Dale+Needham%2C+Mihai+Netea%2C+Myoung-Don+Oh%2C+Sabai+Phyu%2C+Simone+Piva%2C+Ruijin+Qiu%2C+Halima+Salisu-Kabara%2C+Lei+Shi%2C+Naoki+Shimizu%2C+Jorge+Sinclair%2C+Steven+Tong%2C+Alexis+Turgeon%2C+Tim+Uyeki%2C+Frank+van+de+Veerdonk%2C+Steve+Webb%2C+Paula+Williamson%2C+Timo+Wolf%2C+and+Junhua+Zhang.+">Marshall, John C., Srinivas Murthy, Janet Diaz, Neil Adhikari, Derek C. Angus, Yaseen M. Arabi, Kenneth Baillie, Michael Bauer, Scott Berry, Bronagh Blackwood, Marc Bonten, Fernando Bozza, Frank Brunkhorst, Allen Cheng, Mike Clarke, Vu Quoc Dat, Menno de Jong, Justin Denholm, Lennie Derde, Jake Dunning, Xiaobin Feng, Tom Fletcher, Nadine Foster, Rob Fowler, Nina Gobat, Charles Gomersall, Anthony Gordon, Thomas Glueck, Michael Harhay, Carol Hodgson, Peter Horby, YaeJean Kim, Richard Kojan, Bharath Kumar, John Laffey, Denis Malvey, Ignacio Martin-Loeches, Colin McArthur, Danny McAuley, Stephen McBride, Shay McGuinness, Laura Merson, Susan Morpeth, Dale Needham, Mihai Netea, Myoung-Don Oh, Sabai Phyu, Simone Piva, Ruijin Qiu, Halima Salisu-Kabara, Lei Shi, Naoki Shimizu, Jorge Sinclair, Steven Tong, Alexis Turgeon, Tim Uyeki, Frank van de Veerdonk, Steve Webb, Paula Williamson, Timo Wolf, and Junhua Zhang. </a>
2020-06-12
Y - D0.1Res/D0.2Res Qualtrics # 1304, original # 1
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Roots, Not Parachutes: Research Collaborations Combat Outbreaks
<a href="/items/browse?advanced%5B0%5D%5Belement_id%5D=49&advanced%5B0%5D%5Btype%5D=is+exactly&advanced%5B0%5D%5Bterms%5D=Emergency+Management">Emergency Management</a>
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 world. We describe how ‘rooted’ research collaborations can establish capacity for pathogen surveillance and facilitate rapid outbreak responses.
<a href="/items/browse?advanced%5B0%5D%5Belement_id%5D=39&advanced%5B0%5D%5Btype%5D=is+exactly&advanced%5B0%5D%5Bterms%5D=Nathan+L.+Yozwiak%2C+Christian+T.+Happi%2C+Donald+S.+Grant%2C+John+S.+Schieffelin%2C+Robert+F.+Garry%2C+Pardis+C.+Sabeti%2C+and+Kristian+G.+Andersen%2C+on+behalf+of+the+Viral+Hemorrhagic+Fever+Consortium+and+the+African+Center+of+Excellence+for+Genomics+of+Infectious+Disease">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 Infectious Disease</a>
2016-06-30
2022-12-07 general asset review - IPC (move to R-Res)
2024-03-28 by J. Mundy – IPC review 2023 (Q2) skipped – bumping to 2024 (Q4)
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2024-06-10
Preliminary results on the efficacy of rVSV-ZEBOV-GP Ebola vaccine using the ring vaccination strategy in the control of an Ebola outbreak in the Democratic Republic of the Congo: an example of integration of research into epidemic response.
<a href="/items/browse?advanced%5B0%5D%5Belement_id%5D=49&advanced%5B0%5D%5Btype%5D=is+exactly&advanced%5B0%5D%5Bterms%5D=Infection+Control">Infection Control</a>
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 here includes data between May 1, 2018 and March 25, 2019.This preliminary analysis was completed with the aim to better understand whether or not the rVSV-ZEBOV-GP candidate vaccine is effective and is contributing to prevent cases when delivered using the ring vaccination strategy.A more detailed analysis is being prepared and will be available in a peer-reviewed journal.
<a href="/items/browse?advanced%5B0%5D%5Belement_id%5D=39&advanced%5B0%5D%5Btype%5D=is+exactly&advanced%5B0%5D%5Bterms%5D=WHO">WHO</a>
2019-04-12
2022-12-07 general asset review - IPC (move to R-T&C)
2024-03-28 by J. Mundy – IPC review 2023 (Q2) skipped – bumping to 2024 (Q4)
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Adult Care
2024-06-10
Evaluating Promising Investigational Medical Countermeasures: Recommendations in the Absence of Guidelines
<a href="/items/browse?advanced%5B0%5D%5Belement_id%5D=49&advanced%5B0%5D%5Btype%5D=is+exactly&advanced%5B0%5D%5Bterms%5D=Research">Research</a>
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 of financial incentive for pharmaceutical companies to develop interventions for many of the diseases, lack of clinical research capacity in areas where these diseases are endemic, and the ethical dilemmas related to conducting scientific research in humanitarian emergencies.
<a href="/items/browse?advanced%5B0%5D%5Belement_id%5D=39&advanced%5B0%5D%5Btype%5D=is+exactly&advanced%5B0%5D%5Bterms%5D=NETEC+SPRN+Medical+Countermeasures+Working+Group">NETEC SPRN Medical Countermeasures Working Group</a>
Nahid Bhadelia, Lauren Sauer, Theodore J. Cieslak, Richard T. Davey, Susan McLellan, Timothy M. Uyeki, and Mark G. Kortepeter; writing on behalf of National Ebola Training and Education Center's Special Pathogens Research Network (SPRN)'s Medical Countermeasures Working Group Mary Akers, Kerry Dierberg, Dan Eiras, Jared Evans, Elena Figueroa, Colleen Kraft, Chris Kratochvil, Karen Martins, Greg Measer, Aneesh Mehta, Jean Hu-Primmer, George Risi.
2019-02-19
2022-09-27 - general asset review - Treatment & Care group
2022-12-07 general asset review - IPC (change to R-T&C)
<a href="/items/browse?advanced%5B0%5D%5Belement_id%5D=51&advanced%5B0%5D%5Btype%5D=is+exactly&advanced%5B0%5D%5Bterms%5D=Publication">Publication</a>
2025-09-27
The Special Pathogens Research Network: Enabling Research Readiness
<a href="/items/browse?advanced%5B0%5D%5Belement_id%5D=49&advanced%5B0%5D%5Btype%5D=is+exactly&advanced%5B0%5D%5Bterms%5D=Research">Research</a>
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, Liberia, and Sierra Leone, as well as in the United States and Europe, where a total of 27 patients with EVD received care in biocontainment units.
<a href="/items/browse?advanced%5B0%5D%5Belement_id%5D=39&advanced%5B0%5D%5Btype%5D=is+exactly&advanced%5B0%5D%5Bterms%5D=Colleen+S.+Kraft%2C+Mark+G.+Kortepeter%2C+Bruce+Gordon%2C+Lauren+M.+Sauer%2C+Erica+S.+Shenoy%2C+Daniel+P.+Eiras%2C+LuAnn+Larson%2C+Jennifer+A.+Garland%2C+Aneesh+K.+Mehta%2C+Kevin+Barrett%2C+Connie+S.+Price%2C+Caroline+Croyle%2C+Lauren+R.+West%2C+Brooke+Noren%2C+Susan+Kline%2C+Christa+Arguinchona%2C+Henry+Arguinchona%2C+Jonathan+D.+Grein%2C+Chad+Connally%2C+Susan+McLellan%2C+George+F.+Risi%2C+Timothy+M.+Uyeki%2C+Richard+T.+Davey+Jr.%2C+Jo+Ellen+Schweinle%2C+Michelle+M.+Schwedhelm%2C+Melissa+Harvey%2C+Richard+C.+Hunt%2C+and+Christopher+J.+Kratochvil.">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, Christa Arguinchona, Henry Arguinchona, Jonathan D. Grein, Chad Connally, Susan McLellan, George F. Risi, Timothy M. Uyeki, Richard T. Davey Jr., Jo Ellen Schweinle, Michelle M. Schwedhelm, Melissa Harvey, Richard C. Hunt, and Christopher J. Kratochvil.</a>
2019-02-19
Y - D0.1Res/D0.2Res Qualtrics # 1304, original # 1
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NETEC - Online Course - Overview of Clinical Research
<a href="/items/browse?advanced%5B0%5D%5Belement_id%5D=49&advanced%5B0%5D%5Btype%5D=is+exactly&advanced%5B0%5D%5Bterms%5D=Research">Research</a>
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 retention, drug accountability and study closure are also discussed.
<a href="/items/browse?advanced%5B0%5D%5Belement_id%5D=39&advanced%5B0%5D%5Btype%5D=is+exactly&advanced%5B0%5D%5Bterms%5D=NETEC">NETEC</a>
2018-11-06
<a href="/items/browse?advanced%5B0%5D%5Belement_id%5D=51&advanced%5B0%5D%5Btype%5D=is+exactly&advanced%5B0%5D%5Bterms%5D=Online+Course">Online Course</a>
2024-01-01
Completing the Development of Ebola Vaccines: CURRENT STATUS, REMAINING CHALLENGES, AND RECOMMENDATIONS
<a href="/items/browse?advanced%5B0%5D%5Belement_id%5D=49&advanced%5B0%5D%5Btype%5D=is+exactly&advanced%5B0%5D%5Bterms%5D=Treatment+%26+Care">Treatment & Care</a>
In the third major report from the Wellcome Trust–CIDRAP Ebola Vaccine Team B reflects on progress to date and the remaining challenges faced.
<a href="/items/browse?advanced%5B0%5D%5Belement_id%5D=39&advanced%5B0%5D%5Btype%5D=is+exactly&advanced%5B0%5D%5Bterms%5D=University+of+Minnesota%2C+Center+for+Infectious+Disease+Research+and+Policy">University of Minnesota, Center for Infectious Disease Research and Policy</a>
2017-01-17
2022-09-27 - general asset review - Treatment & Care group
<a href="/items/browse?advanced%5B0%5D%5Belement_id%5D=51&advanced%5B0%5D%5Btype%5D=is+exactly&advanced%5B0%5D%5Bterms%5D=Publication">Publication</a>
2025-09-27
Integrating Clinical Research into Epidemic Response
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<table><thead><tr><td>
<p><b>Table of Contents</b></p>
</td>
<td>
<p><b> </b></p>
</td>
</tr></thead><tbody><tr><td>
<p>Front Matter</p>
</td>
<td>
<p>i-xxvi</p>
</td>
</tr><tr><td>
<p>Summary</p>
</td>
<td>
<p>1-18</p>
</td>
</tr><tr><td>
<p>1 Introduction</p>
</td>
<td>
<p>19-36</p>
</td>
</tr><tr><td>
<p>2 Conducting Clinical Research During an Epidemic</p>
</td>
<td>
<p>37-82</p>
</td>
</tr><tr><td>
<p>3 Assessment of Therapeutic Trials</p>
</td>
<td>
<p>83-112</p>
</td>
</tr><tr><td>
<p>4 Assessment of Vaccine Trials</p>
</td>
<td>
<p>113-154</p>
</td>
</tr><tr><td>
<p>5 Strengthening Capacity for Response and Research</p>
</td>
<td>
<p>155-198</p>
</td>
</tr><tr><td>
<p>6 Engaging Communities in Research and Response</p>
</td>
<td>
<p>199-222</p>
</td>
</tr><tr><td>
<p>7 Facilitating International Coordination and Collaboration</p>
</td>
<td>
<p>223-250</p>
</td>
</tr><tr><td>
<p>Appendix A: Study Approach and Methods</p>
</td>
<td>
<p>251-286</p>
</td>
</tr><tr><td>
<p>Appendix B: Clinical Trial Designs</p>
</td>
<td>
<p>287-296</p>
</td>
</tr><tr><td>
<p>Appendix C: Ethical Principles for Research with Human Subjects</p>
</td>
<td>
<p>297-300</p>
</td>
</tr><tr><td>
<p>Appendix D: Biographical Sketches of Committee Members and Staff</p>
</td>
<td>
<p>301-316</p>
</td>
</tr></tbody></table>
<a href="/items/browse?advanced%5B0%5D%5Belement_id%5D=39&advanced%5B0%5D%5Btype%5D=is+exactly&advanced%5B0%5D%5Bterms%5D=National+Academies+Press">National Academies Press</a>
2017-04-12
Flexible Clinical Trial Design Suitable for Emerging Disease Outbreaks
<a href="/items/browse?advanced%5B0%5D%5Belement_id%5D=49&advanced%5B0%5D%5Btype%5D=is+exactly&advanced%5B0%5D%5Bterms%5D=Research">Research</a>
FDA CDER statisticians are designing trials with adaptive features to make clinical evaluation of new drug treatments more efficient and informative. (FDA)<br /><br />More information on the subject <a href="https://www.fda.gov/drugs/regulatory-science-action/impact-story-flexible-clinical-trial-design-suitable-emerging-disease-outbreaks" target="_blank" rel="noreferrer noopener">can be read here</a>.
<a href="/items/browse?advanced%5B0%5D%5Belement_id%5D=39&advanced%5B0%5D%5Btype%5D=is+exactly&advanced%5B0%5D%5Bterms%5D=U.S.+Food+and+Drug+Administration+%28FDA%29">U.S. Food and Drug Administration (FDA)</a>
2018-08-13
Ebola-Marburg R&D (Research and Development) Roadmap
<a href="/items/browse?advanced%5B0%5D%5Belement_id%5D=49&advanced%5B0%5D%5Btype%5D=is+exactly&advanced%5B0%5D%5Bterms%5D=Research">Research</a>
Video explaining the WHO's Research and Development Roadmap.
<a href="/items/browse?advanced%5B0%5D%5Belement_id%5D=39&advanced%5B0%5D%5Btype%5D=is+exactly&advanced%5B0%5D%5Bterms%5D=CIDRAP">CIDRAP</a>
2018-05-15