Implications of coronavirus disease (COVID-19) on methodological aspects of ongoing clinical trials
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This guidance covers actions that sponsors of ongoing clinical trials affected by the coronavirus disease (COVID-19) pandemic should take to help ensure the integrity of their studies and interpretation of study results while safeguarding the safety of trial participants as a first priority.
This complements the good clinical practice guidance on how sponsors should adjust the management of clinical trials and participants during the COVID-19 pandemic.
The guidance is under a four-week public consultation until 25 April 2020.
Please note that further updates are possible and likely given the rapidly evolving nature of the pandemic.