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European guidance on the management of clinical trials during the COVID-19 pandemic

Written by Editor on . Posted in News.

A European guidance
(https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-10/guidanceclinicaltrials_covid19_en.pdf) has been published, which will provide directions to sponsors and investigators on the subject of

  • clinical trials for treatment or prevention of COVID-19,
  • ongoing clinical trials in Belgium, and
  • the advice for new non-COVID-19-related clinical trials.

This guidance is supported by the FAMHP, BAREC and the CT-College.

Please note that on some subjects, a more detailed national guidance is being prepared on the conditions for direct distribution of the medicinal product to the patient.

This national guidance is expected to be published by the 25th of March 2020 and will be attuned to the European guidance.