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

On 10 February 2022 the European Commission announced the updated guidance on the clinical trials management during the COVID-19 pandemic in Europa.

The COVID-19 pandemic has been continuously putting national health care systems under high pressure. In some Member States the capacity of the health-care system has been at its limits since the beginning of the pandemic. Against this background, pragmatic and harmonized actions are required to ensure the necessary flexibility and procedural simplifications needed to maintain the integrity of the trials, to ensure the rights, safety and wellbeing of trial participants and the protection and safety of clinical trial staff during this prolonged global public health crisis. The points mentioned below are intended to provide guidance and clarity for all parties involved in clinical trials during this time. It should be noted that the simplification measures proposed in this document will only last during the current public health crisis until the revocation of this Guidance, when there is a consensus that the period of the COVID-19 outbreak in the EU/EEA, has passed.

This document sets out to include most of the current guidance across Member States with the aim of serving as a harmonized EU-level set of recommendations.

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