Heema Desai¹ and Kaushal Kapadia²*

¹Ph.D. Clinical Research (Student), Texila American University, Mumbai, Maharashtra, India
²Ph.D. Clinical Research, A Clinical Research Professional, Mumbai, Maharashtra, India

*Corresponding Author: Kaushal Kapadia, Ph.D. Clinical Research, A Clinical Research Professional, Mumbai, Maharashtra, India.

Received: August 25, 2022; Published: September 22, 2022

Abstract

COVID-19 pandemic has hit the global healthcare and research surface with a staggering blow, however, with some drawbacks and imperfections the clinical research fraternity worldwide has held up the principles of rights, safety and well-being of patients. Lack of logistical, transport permissions in different parts of the world alongside the severe infection capacity of the deadly virus had put intermittent pauses to clinical trials in the last two years. This survey based observational study focuses on the real-time experience and opinions of the clinical research associates (CRAs) who had been carrying on with their on-going clinical trials unperturbed with the apparent obstacles. The respondents faced different types of issues in the accountability of investigational product, accessibility to central laboratories, conformity review of informed consent of the subjects, and most importantly, complexities in the adapted new methods of source data verifications in their monitoring activities. The suggestions generated in the survey on how the existing loopholes can be addressed and what should be the focus on such changed model of monitoring, were highlighted. In the lines of ongoing initiatives by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), the various clinical trials strategic working groups, and regulatory authorities like USFDA, this survey-based study highlights the need of technology adoption. Going forward, remote and hybrid monitoring models can be cost-effective and possibly more efficient than onsite visit-based monitoring model.

Keywords: COVID-19; Remote Monitoring; Risk Based Monitoring; Hybrid Monitoring

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Citation: Heema Desai and Kaushal Kapadia. “A Pilot Study to Understand an Impact During the COVID-19 Lockdown in Clinical Trial Monitoring Activities and its Management". Acta Scientific Clinical Case Reports 3.10 (2022): 21-26.

Copyright: © 2022 Heema Desai and Kaushal Kapadia. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.