EU Guidelines on COVID-19 and clinical trials

 

CCMO News item: Conditions for (re)starting clinical research in healthcare institutions and CRUs aligned

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NEN publishes recommendations for reusing single-use medical devices and provides guidance for non-medical face masks (Dutch)

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The European Data Protection Board (EDPD) adopted guidelines (document) on the processing of health data for research purposes in the context of the COVID-19 outbreak and guidelines on geolocation and other tracing tools in the context of the COVID-19 outbreak:

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New guidance (MDCG 2020-4) on NB audits during COVID-19 quarantine (ec.europa.eu)

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Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on the conduct of clinical trials with and supply of medicinal products for human use containing or consisting of genetically modified organisms intended to treat or prevent coronavirus disease (EC)

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Guidance on medical devices, active implantable medical devices and in vitro diagnostic medical devices in the COVID-19 context (ec.europa.eu)

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Coronavirus: more space for eHealth (Dutch)(IGJ)

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Coronavirus: Free access to European standards for personal protective equipment, medical devices (in-cyprus)

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Guidance French Authorities with respect to ongoing clinical trials during the coronavirus pandemic

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Guidance on the Management of Clinical Trials during the COVID-19 (Coronavirus) pandemic (updated to version 3 on April 28) (ec.europa.eu)

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Coronavirus: impact on medical-scientific research with humans (Dutch)(IGJ)

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Coronavirus: impact on conducting clinical research with humans that falls under the WMO (Dutch)(IGJ)

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Dutch Central Clinical Research Committee provides guidance (Dutch, English) for your clinical trial following corona: patient safety first, documentation of protocol deviations can follow later (updated on May 26)(CCMO)