EU Guidelines on COVID-19 and clinical trials

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

https://english.ccmo.nl/about-the-ccmo/news/2020/05/19/conditions-for-restarting-studies-in-clinical-research-units

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NEN provides guidance for non-medical face masks (Dutch):

https://www.nen.nl/Nieuws/Nieuws/NEN-publiceert-aanbevelingen-voor-nietmedische-mondkapjes.htm

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The European Data Protection Board (EDPD) adopted guidelines 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:

https://edpb.europa.eu/news/news/2020/european-data-protection-board-twenty-third-plenary-session-edpb-adopts-further-covid_en

https://edpb.europa.eu/our-work-tools/our-documents/guidelines/guidelines-032020-processing-data-concerning-health-purpose_en

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New guidance (MDCG 2020-4) on NB audits during COVID-19 quarantine:

https://ec.europa.eu/docsroom/documents/40705

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Guidance on medical devices, active implantable medical devices and in vitro diagnostic medical devices in the COVID-19 context:

https://ec.europa.eu/docsroom/documents/40607

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Coronavirus: more space for eHealth (Dutch):

https://www.igj.nl/zorgsectoren/medische-technologie/nieuws/2020/03/26/coronavirus-meer-ruimte-voor-e-health

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Coronavirus: Free access to European standards for personal protective equipment, medical devices:

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

https://www.ansm.sante.fr/Activites/Essais-cliniques/Covid-19-Ongoing-clinical-trials/(offset)/1

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

https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-10/guidanceclinicaltrials_covid19_en.pdf

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Coronavirus: impact on medical-scientific research with humans (Dutch, updated on April 14) :

https://www.igj.nl/actueel/nieuws/2020/03/20/coronavirus-impact-op-medisch-wetenschappelijk-onderzoek-met-mensen

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Coronavirus: impact on conducting clinical research with humans that falls under the WMO (Dutch, updated on April 28):

https://www.igj.nl/documenten/publicaties/2020/04/14/coronavirus-covid-19-impact-op-het-verrichten-en-uitvoeren-van-klinisch-onderzoek-dat-onder-de-wet-medisch-wetenschappelijk-onderzoek-met-mensen-wmo-valt

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Dutch Central Clinical Research Committee provides guidance for your clinical trial following corona: patient safety first, documentation of protocol deviations can follow later (updated on May 22):

https://www.ccmo.nl/actueel/nieuws/2020/03/13/advies-voor-de-uitvoering-van-klinisch-onderzoek-ten-tijde-van-de-beperkende-maatregelen-door-het-coronavirus

In English:

https://english.ccmo.nl/about-the-ccmo/news/2020/03/16/recommendations-for-the-conduct-of-clinical-research-at-the-time-of-restrictive-measures-due-to-the-coronavirus