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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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Detalles Bibliográficos
Autores principales:	Woods, Patricia, Flynn, Maura, Monach, Paul, Visnaw, Karen, Schiller, Sara, Holmberg, Erika, Leatherman, Sarah, Ferguson, Ryan, Branch-Elliman, Westyn
Formato:	Online Artículo Texto
Lenguaje:	English
Publicado:	Elsevier 2021
Materias:	Article
Acceso en línea:	https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8234262/ https://www.ncbi.nlm.nih.gov/pubmed/34222708 http://dx.doi.org/10.1016/j.conctc.2021.100804

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