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Ryan Majkowski

affiliation not provided to SSRN

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Clinical trial coordination of multifaceted ethical and regulatory oversight entities during the COVID-19 public health emergency

Number of pages: 32 Posted: 30 Oct 2025
Amy L. Gawad, Jessica Mendoza, Megan Singleton, Ryan Majkowski, Erica Hopkins, Jordyn Carll, Cindy MacInnis, Daniel Amirault, Bahiyyah Jackson, Nichol McBee, Andrew Mould, Lindsay M. Eyzaguirre, Cecilia Pessoa-Gingerich, Shmuel Shoham, David Sullivan and Karen Lane
Johns Hopkins University, affiliation not provided to SSRN, affiliation not provided to SSRN, affiliation not provided to SSRN, affiliation not provided to SSRN, affiliation not provided to SSRN, affiliation not provided to SSRN, affiliation not provided to SSRN, affiliation not provided to SSRN, Johns Hopkins University - School of Medicine, affiliation not provided to SSRN, affiliation not provided to SSRN, affiliation not provided to SSRN, Johns Hopkins University, Johns Hopkins University - Bloomberg School of Public Health and Johns Hopkins University - School of Medicine
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Abstract:

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COVID-19 clinical trials, clinical trial management, convalescent covid plasma, single institutional review board (sIRB) oversight, Human Research Protection Official (HRPP) reviews, Informed Consent Form, return of trial results