During the COVID-19 pandemic, federal and state restrictions hindered many aspects of clinical trials, such as recruiting patients, which made completing required research tasks difficult or impossible. Many existing guidance documents and policies were redesigned rapidly during the pandemic to accommodate COVID-19-related emergencies. Such policies laid the foundation for change in clinical research. The purpose of this clinical research regulatory review is to determine how regulatory bodies such as the Food and Drug Administration, Office of Human Research Protections, and institutional review boards have responded to challenges in running clinical trials during the COVID-19 pandemic.

''This guidance provides clinical advice to healthcare providers about how to manage patients who present with COVID-19 symptoms, or a positive COVID-19 RAT, within 90 days of a priorprobable COVID-19 infection''--Introduction.

CORONAVIRUS DISEASE 2019 (COVID-19) CORONAVIRUS DISEASE 2019 (COVID-19) Provides comprehensive coverage of all key aspects of COVID-19, including: etiology, diagnosis, symptomatology, management, and treatment Coronavirus Disease 2019 (COVID-19): A Clinical Guide provides healthcare professionals at all levels with up-to-date knowledge about the clinical, epidemiological, genomic, virological, and radiologic features of COVID-19. Consolidating multiple systematic reviews and meta-analyses into a single volume, this comprehensive textbook also addresses health policies, mass casualty planning, healthcare worker safety, economic impact, lessons for future outbreaks, and other para-clinical and social aspects of the COVID-19 pandemic. The text presents a thorough summary and critical analysis of COVID-19 based on an exhaustive review of recently published literature and data. Topics include the virologic characteristics of SARS-CoV-2, pulmonary and extrapulmonary manifestations and consequences of COVID-19, prevention and transmission control, the pandemic’s indirect impact to the care and management of other diseases, passive immunotherapy and its implications, diagnostic and treatment approaches for critically ill patients, and more. Edited by leading ­practitioners at the forefront of COVID-19 research, this invaluable resource: Integrates clinical, radiological, and epidemiological data and discussion of prevention, diagnosis, and treatment Reviews the epidemiology, mechanisms of action, manifestations, and management of cardiovascular, neurological, and pulmonary diseases associated with COVID-19 Covers diagnostic technologies, includes radiologic imaging, and RT-PCR testing Explores therapeutic approaches for managing a variety of complications Discusses post-vaccination symptom management and implications of immunization Addresses COVID-19 in pediatrics, in cancer patients, and in patients with lung disease, diabetes, ­hypertension, obesity, and other underlying conditions Coronavirus Disease 2019 (COVID-19): A Clinical Guide is an indispensable source of information for all clinicians, researchers, epidemiologists, nurses, radiologists, and healthcare managers working to address any aspect of the COVID-19 pandemic.

In response to a request from the Office of Science and Technology Policy and the Office of the Assistant Secretary for Preparedness and Response, the National Academies of Sciences, Engineering, and Medicine convened a standing committee of experts to help inform the federal government on critical science and policy issues related to emerging infectious diseases and other 21st century health threats. This set of Rapid Expert Consultations are the first of their kind and represent the best evidence available to the Committee at the time each publication was released. The science on these issues is continually evolving, and the scientific consensus the Committee reaches on these topics will likely evolve with it. The standing committee includes members with expertise in emerging infectious diseases, public health, public health preparedness and response, biological sciences, clinical care and crisis standards of care, risk communication, and regulatory issues.

''This guidance provides clinical advice to healthcare providers about how to manage people who present with COVID-19 symptoms, or a positive COVID-19 RAT after a previous COVID-19 infection. Changes have been made to the Interim Guidance (5th May 2022) based on emerging evidence and to incorporate feedback from primary care, microbiologists and public health units. This advice has also been aligned with the change to the COVID-19 Public Health Response (Self-isolation Requirements and Permitted Work) Order 2022. Expert opinion in New Zealand about the correct management of reinfection is varied. This guidance may be subject to review as further evidence becomes available''--Introduction.