Difference between revisions of "Resource:A2c18386-f92b-4d91-83a2-98a0792e7dce"
From The Embassy of Good Science
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| − | |Is About= | + | |Is 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. |
| − | |Important For=All stakeholders in research | + | |Important Because=In the period of a 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!. |
| + | |Important For=All stakeholders in research; Authors; Doctoral students; Early career researchers; Laboratory researchers; Patients/participants; Peer reviewers; Pharma Industry; Researchers; Research institutions | ||
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| + | |Involves=European Commission; European Medicines Agency (EMA); Heads of Medicines Agencies; European Association for Hemophilia & Allied Disorders | ||
| + | |Has Timepoint=2021 | ||
| + | |Has Virtue And Value=Flexibility; Integrity; Safety; Objectivity | ||
| + | |Related To Research Area=LS - Life Sciences; LS 07.08 - Health services, health care research; LS 07.09 - Public health and epidemiology; LS 07 - Diagnostic Tools, Therapies and Public Health | ||
| + | }} | ||
Latest revision as of 09:16, 27 July 2021
ResourcesGuidelines
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 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
