The EMA's guidelines for the management of clinical trials during the COVID 19 pandemic (pdf) was updated and now also includes:
- safety reporting
- distribution of in-vitro diagnostics
- medical devices
- auditing
- informed consent
EMA published guidance to help ensure the integrity of their studies and the interpretation of study results while safeguarding the safety of trial participants as a first priority. This Guidance on methodological aspects of ongoing clinical trials during COVID-19 complements the above highlighted guidelines for the management of clinical studies during COVID-19.
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