Guidance on the Management of Clinical Trials during the COVID-19 Pandemic
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Guidance on the Management of Clinical Trials during the COVID-19 Pandemic
What is this about?
Guidance for all stakeholders involved in clinical trials during the COVID-19 pandemic in Europe. This document aims to provide guidance and prevent the disruption of clinical trials during the ongoing crisis. Even when health systems reach their limits, the integrity of trials, the rights, and the safety of the trial participants and staff must be preserved and protected. For this reason, this guideline provides harmonized, simplified and pragmatic measures.
Why is this important?
In the period of a global pandemic, pragmatic actions are required to ensure the integrity of research. This document provides simplified measures to ensure, integrity, safety, and the rights of those involved in research trials during the ongoing health crisis. However, this document is only valid in the EU/EEA as long as the COVID-19 outbreak is not over. The Guidance on the Management of Clinical Trials during the COVID-19 Pandemic has been endorsed by the European Association for Hemophilia & Allied Disorders, in their report: Reducing bureaucracy in clinical trials: now is the time!.
For whom is this important?
All stakeholders in researchAuthorsDoctoral studentsEarly career researchersLaboratory researchersPatients/participantsPeer reviewersPharma IndustryResearchersResearch institutions
