Implementation of documented and written informed consent for clinical trials of communicable diseases: Lessons learned, barriers, solutions, future directions identified during the conduct of a COVID-19 clinical trial

Implementation of documented and written informed consent for clinical trials of communicable diseases: Lessons learned, barriers, solutions, future directions identified during the conduct of a COVID-19 clinical trial

Background and objective: The communicable nature of many infectious diseases, including SARS-CoV-2, creates challenges for implementing and obtaining regulatory-compliant written informed consent. The goal of this project was to identify and evaluate processes that address these barriers while main...

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Bibliographic Details
Main Authors: Patricia Woods, Maura Flynn, Paul Monach, Karen Visnaw, Sara Schiller, Erika Holmberg, Sarah Leatherman, Ryan Ferguson, Westyn Branch-Elliman
Format: Article
Language:English
Published: Elsevier 2021-09-01
Series:Contemporary Clinical Trials Communications
Online Access:http://www.sciencedirect.com/science/article/pii/S2451865421001058

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http://www.sciencedirect.com/science/article/pii/S2451865421001058

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