Guidance on the Management of Clinical Trials During the Covid-19 (Coronavirus) Pandemic

On 4 February 2021 the EMA published guidance version 4 with the key changes of remote source data verification.

This guidance provides specific advice for clinical-trial sponsors on how they should adjust the management of clinical trials and participants during the COVID-19 pandemic. It covers how to deal with the extraordinary situations that the pandemic presents. These include, for example, the self-isolation or quarantine of trial participants, limited access to public places (including hospitals) due to the risk of spreading infections and reallocation of healthcare professionals. It also advises on how to communicate these changes to the national competent authorities.

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