Printed in July’s 2020 issue of RQA‘s Quasar

Global regulatory authorities acknowledge the impact and increasing pressure that the COVID-19 pandemic is putting on global health care systems. Against this background, pragmatic and harmonised actions are required to ensure the necessary flexibility and procedural simplifications needed to maintain the integrity of the trials, to ensure the rights, safety and wellbeing of trial participants and the safety of clinical trial staff during this global public health crisis. The information consolidated below from the EMA1, FDA2 and the MHRA3 are intended to provide guidance and clarity for all parties involved in clinical trials during this time.

  1. EMA Guidance on Management of Clinical Trials During COVID-19 Pandemic, Version 3, 28 April 2020 Click to view source
  2. FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Public Health Emergency, updated 03 June 2020 Click to view source
  3. MHRA: Managing clinical trials during Coronavirus (COVID-19) – How investigators and sponsors should manage clinical trials during COVID-19, updated 21st May 2020 Click to view source

For a copy of the full article which includes a comparison table between EMA, FDA and MHRA guidance click here