EU Guidelines on COVID-19 and clinical trials

 

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

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Conditions for gradually (re)starting studies in clinical research units (IGJ). CCMO has published a document on the conditions for the (re)start of studies in clinical research units.

Coronavirus (COVID-19): impact on the conduct of clinical trials under the Medical Research Involving Human Subjects Act (WMO)

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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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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)