Difference between revisions of "Resource:A2c18386-f92b-4d91-83a2-98a0792e7dce"
From The Embassy of Good Science
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|Resource Type=Guidelines | |Resource Type=Guidelines | ||
|Title=Guidance on the Management of Clinical Trials during the COVID-19 Pandemic | |Title=Guidance on the Management of Clinical Trials during the COVID-19 Pandemic | ||
| − | |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 | + | |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 Because=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. 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 Because=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!. |
|Important For=All stakeholders in research; Authors; Doctoral students; Early career researchers; Laboratory researchers; Patients/participants; Peer reviewers; Pharma Industry; Researchers; Research institutions | |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 | |Involves=European Commission; European Medicines Agency (EMA); Heads of Medicines Agencies; European Association for Hemophilia & Allied Disorders | ||
|Has Timepoint=2021 | |Has Timepoint=2021 | ||
| − | |Has Virtue And Value=Flexibility; Integrity; Safety; | + | |Has Virtue And Value=Flexibility; Integrity; Safety; Objectivity |
}} | }} | ||
Revision as of 10:06, 29 June 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 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
