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Clinical Trial Drug Safety Assessment for Studies and Submissions Impacted by COVID-19

Abstract–In this article, we provide guidance on how safety analyses and reporting of clinical trial safety data may need to be modified, given potential impact from the COVID-19 pandemic. Impact could include missed visits, alternative methods for assessments (such as virtual visits), alternative l...

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Detalhes bibliográficos
Publicado no:Stat Biopharm Res
Main Authors: Nilsson, Mary, Crowe, Brenda, Anglin, Greg, Ball, Greg, Munsaka, Melvin, Shahin, Seta, Wang, Wei
Formato: Artigo
Idioma:Inglês
Publicado em: Taylor & Francis 2020
Assuntos:
Acesso em linha:https://ncbi.nlm.nih.gov/pmc/articles/PMC8011485/
https://ncbi.nlm.nih.gov/pubmed/34191982
https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1080/19466315.2020.1804444
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