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\begin{document}

\title{Research on the Effects of the Global Static Management Policy against
COVID-19 in 2022 on Clinical Trials in Shanghai}



\author[1]{Zhaodan Tan}%
\author[1]{Zengguang Xu}%
\author[1]{Yan Shi}%
\affil[1]{Shanghai East Hospital}%


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  \date{June 10, 2024}


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\begin{abstract}
Aims: To improve the countermeasures of clinical trial institutions
against major public health events such as COVID-19. Methods: A
questionnaire was created to investigate the effects of the global
static management policy against COVID-19 on clinical trials in Shanghai
in 2022. And the convenience sampling combined with snowball sampling
were adopted to interview clinical research coordinators (CRC) and
clinical research associates(CRA) on the platform of SOJUMP as well as
WeChat. Results: 156 valid questionnaires were collected, with an
effective recovery rate of 93.98\%. 98.07\% of the respondents believed
that the effects was severe. The extent of effects on different links of
clinical trials was different (rank sum test P\textless{}0.01), being
great on medication/follow-up (76.28\% of significant effects),
monitoring/audit (74.36\%) and screening/admission (71.79\%).The
protocol deviations associated with out of visit window (experienced by
94.23\% of respondents, during the static management policy), inspection
(78.85\%), medication (67.95\%) and withdrawal (62.82\%). And the
interviewees reported 49.66\% of the exclusion should blame the epidemic
situation. The development of online-office or remote-ethics meetings
alleviated the impact of lockdown policy on approval/ethics/contract and
data cleaning/site closing. 90.98\% of oral drugs could be sent by
express delivery, but only 1.28\% had the experience of online informed
consent and remote inspection. Conclusions: We shall speed up the
application of the intelligent clinical trial system and remote
monitoring system, realize the transformation to a new model of
patient-centered clinical trial, and improve the ability to cope with
major public health events such as COVID-19.%
\end{abstract}%



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\textbf{Hosted file}

\verb`20230228-Research on the Effects of the Global Static Management Policy against COVID-19 in 2022 on Clinical Trials in Shanghai.docx`  available at \url{https://authorea.com/users/591263/articles/627289-research-on-the-effects-of-the-global-static-management-policy-against-covid-19-in-2022-on-clinical-trials-in-shanghai}

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