GUIDANCE ON THE MANAGEMENT OF CLINICAL TRIALS DURING THE COVID-19 (CORONAVIRUS) PANDEMIC
Version 4 04/02/2021
Key changes from v3 (27-04-2020): remote source data verification
The European Medicines Agency (EMA), Good Clinical Practice (GCP) Inspectors Working Group (GCP IWG), the Clinical Trials Facilitation and Coordination Group (CTFG, a working group of the Heads of Medicines Agency (HMA), the Clinical Trials
Expert Group (CTEG, a working group of the European Commission representing Ethics Committees and National Competent Authorities (NCA)) and the European Commission (EC) acknowledge the impact of COVID-19 on the health system and broader society, and the impact it may have on clinical trials and trial participants
Extraordinary measures may need to be implemented and trials adjusted due, among others, to trial participants being in self-isolation/quarantine, limited access to public places (including hospitals) due to the risk of spreading infection, and health care professionals being committed to critical tasks.
The COVID-19 pandemic is rapidly escalating putting national health care systems under continuously increasing pressure. In some Member States the capacity of the health-care system has already reached its limits. Against this background, pragmatic and harmonised 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 safety of clinical trial staff during this 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.
Sponsors and investigators should note that due to the rapidly evolving situation further updates to this guidance are possible and likely. Member States are encouraged to implement the harmonised guidance to the maximum possible extent to mitigate and slow down the disruption of clinical research in Europe during the public health crisis. At the same time, sponsors and investigators need to take into account that national legislation and derogations cannot be superseded. Member States shall complement this guidance to create additional clarity on specific national legal requirements and derogations to them
This document sets out to include most of the current guidance across Member States with the aim of serving as a harmonised EU-level set of recommendations. Hence, this guidance was drafted and supported by the CTEG, EMA, the CTFG of the HMA and the GCP IWG coordinated by the EMA. Commissioner Kyriakides shared this guidance with the Health Ministers and no Member State has raised any concern with this guidance in the videoconference of Ministers of Health of 27 April 2020.