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13 Government, Regulatory Portals and Guidance Resources


CDC COVID-19 Community Survey Question Bank

https://cde.nlm.nih.gov/formView?tinyId=Kcceysolt

The CDC COVID-19 Community Survey Question Bank contains potential questions for community surveys and is offered by the CDC to interested researchers. It is not an official CDC form or data collection instrument. You can export the form or individual questions, but you need to be logged into the NIH CDE Repository with a UMLS account to do so. Sign up for a UMLS account here: https://uts.nlm.nih.gov/license.html.



FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Pandemic

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/fda-guidance-conduct-clinical-trials-medical-products-during-covid-19-pandemic

The Food and Drug Administration (FDA or Agency) plays a critical role in protecting the United States from threats including emerging infectious diseases, including the Coronavirus Disease 2019 (COVID-19) pandemic. FDA is committed to providing timely guidance to support continuity and response efforts to this pandemic.


Guidance on the Management of Clinical Guidance on the Management of Clinical pandemic Trials during the COVID-19 (Coronavirus) pandemic

https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-10/guidanceclinicaltrials_covid19_en.pdf

The European Medicines Agency (EMA), Good Clinical Practice (GCP) Inspectors Working Group, the Clinical Trials Facilitation and Coordination Group (CTFG, a working group of the Heads of Medicines Agency (HMA)), the Clinical Trials Expert Group (CTEG, a working group of the European Commission representing Ethics Committees and National Competent Authorities) and the European Commission (EC) acknowledge the impact of COVID-19 on the health system and broader society, and the impact it may have on clinical trials and trial participants1 . Extraordinary measures may need to be implemented and trials adjusted due to e.g. trial participants being in self-isolation/quarantine, limited access to public places (including hospitals) due to the risk of spreading infections, and health care professionals being committed to critical tasks. Therefore, EMA, EC and HMA strongly support the efforts of the GCP Inspectors’ Working Group for developing a harmonised EU/EEA-level guidance to mitigate the negative effects of the COVID-19 pandemic on the conduct of clinical trials.



Master Question List for COVID-19 (caused by SARS-CoV-2)

https://www.dhs.gov/publication/st-master-question-list-covid-19

The Department of Homeland Security (DHS) Science and Technology Directorate (S&T) developed the following “master question list” that quickly summarizes what is known, what additional information is needed, and who may be working to address such fundamental questions as, “What is the infectious dose?” and “How long does the virus persist in the environment?” The Master Question List (MQL) is intended to quickly to present the current state of available information to government decision makers in the operational response to COVID-19 and allow structured and scientifically guided discussions across the federal government without burdening them with the need to review scientific reports, and to prevent duplication of efforts by highlighting and coordinating research.



NIH National Library of Medicine - LitCovid

https://www.ncbi.nlm.nih.gov/research/coronavirus/

LitCovid is a curated literature hub for tracking up-to-date scientific information about the 2019 novel Coronavirus. It is the most comprehensive resource on the subject, providing a central access to 10691 (and growing) relevant articles in PubMed. The articles are updated daily and are further categorized by different research topics and geographic locations for improved access. You can learn more at Chen et al. Nature (2020) or our FAQ, and download our data here.





WHO - Global research on coronavirus disease (COVID-19)

https://www.who.int/emergencies/diseases/novel-coronavirus-2019/global-research-on-novel-coronavirus-2019-ncov

WHO is gathering the latest international multilingual scientific findings and knowledge on COVID-19. The global literature cited in the WHO COVID-19 database is updated daily (Monday through Friday) from searches of bibliographic databases, hand searching, and the addition of other expert-referred scientific articles. This database represents a comprehensive multilingual source of current literature on the topic. While it may not be exhaustive, new research is added regularly.