Month: April 2020

Today an updated version of the European guidance was published on EudraLex10:
https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-10/guidanceclinicaltrials_covid19_en.pdf

The related press release announcing the publication can be found here: https://ec.europa.eu/commission/presscorner/detail/en/ip_20_759

The new version contains additional or new information about:

• distributor to trial participant IMP shipment,
• monitoring,
• remote source data verification and
• communication with authorities

Please find an updated version of the European guidance was published on EudraLex-10.

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The aim is to provide sponsors and investigators with guidance on how to mitigate the effects of the pandemic in order to protect the safety, well-being and integrity of trial participants and the integrity of the trial.

The new version contains additional or new information about:

• Informed consent in trials with COVID-19 patients;
• IMP transfer and stocks with patients or at sites;
• Communication with authorities of temporary trial halts due to reasons which are unrelated to the safety of the trial participants;
• Stocks of in critical vitro diagnostics and other medical devices used in a particular trial;
• Safety reporting