2nd version European Guidance
Please find an updated version of the European guidance was published on EudraLex-10.
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