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2nd version European Guidance

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