Clinical data monitoring during COVID-19 pandemic: an experience from a regulatory trial in India

Divya Pillai, Monika Bahl, Padmapriyadarsini C, Ranjan Kumar, Supriya Semwal, Shirali Raina Labroo, Jeyadeepa B.

Abstract

The essence of any clinical or healthcare related discovery is its methodologically sound clinical research and clinical data monitoring. This eventually helps the clinicians to understand the best possible clinical management pathways or patient management at all the levels of healthcare system. The pandemic has had an impact on clinical trial data monitoring as well. New or mixed approaches to routine monitoring have been introduced to ensure the quality of the overall research in these challenging times and are being tested for efficacy, cost-effectiveness while keeping ethical considerations as the main priority. This write up intends to highlight a few steps taken to ensure data integrity and participants’ safety and rights.

Keywords

Clinical data monitoring, Source data verification, COVID–19, Pandemic, Remote or central monitoring

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