European Guidance: UPDATE
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