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Guidance from EMA and France – ongoing trials and Covid-19

March 23, 2020

Please click on the following links for guidance from the EMA and France ANSM on the management of clinical trials during the COVID-19 (Coronavirus) pandemic

EMA

https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-10/guidanceclinicaltrials_covid19_en.pdf

France ANSM

https://www.ansm.sante.fr/Activites/Essais-cliniques/Covid-19-Ongoing-clinical-trials/(offset)/1

Advice for Management of Clinical trials in relation to Coronavirus

Adrian Parrott / Uncategorized /

March 19, 2020

MHRA issues advice for those managing and sponsoring clinical trials

https://mhrainspectorate.blog.gov.uk/2020/03/12/advice-for-management-of-clinical-trials-in-relation-to-coronavirus/

FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Pandemic

Adrian Parrott / Uncategorized /

March 19, 2020

FDA is issuing this guidance to provide general considerations to assist sponsors in assuring the safety of trial participants, maintaining compliance with good clinical practice (GCP), and minimizing risks to trial integrity during the COVID-19 pandemic.

https://www.fda.gov/media/136238/download

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