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European Guidance: UPDATE

Written by Editor on . Posted in News.

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