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Clinical Trial Management Guidelines under Covid-19 – Europe

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Good Clinical Practice (GCP) is referred to an internationally acclaimed ethical and scientific quality standard for designing, recording and reporting trials involving participation of human subjects. Compliance with this standard assures the protection of trial subjects and increases the credibility of clinical trial data.

  1. Self-isolating or keeping trial participants in quarantine.
  2. Limiting their access to public places such as hospitals to reduce the spread of infections
  3. Reallocating healthcare professionals.
  4. Measures are even provided on the ways to communicate such changes to competent national authorities.
An update to this guidance on 28 April 2020 provided additional flexibility and clarification on:The distribution of medicines to trial participants. This takes into account social-distancing measures and possible limitations in trial site and hospital resources;The remote verification of source data (SDV) in the context of social distancing measures. This aims to facilitate activities that support the approval of COVID-19 and other life-saving medicines;Notifying authorities of urgent actions taken to protect trial participants against an immediate hazard, or of other changes taken to support patient safety or data robustness.European Commission: Coronavirus: Commission issues guidance to mitigate clinical trial disruption in the EU
 

The guidance also specifies certain advice on clinical trials for treating COVID-19, including the requirement for bigger, multi-national trial protocols. This is an extension to CHMP’s call urging the EU research community to prioritize large randomized controlled clinical studies as these are supposed to generate some conclusive evidence needed to enable rapid development and approval of potential COVID-19 treatments. It has made it clear that the participation of all EU countries is a necessity in these trials (CHMP statement: A call to pool EU research resources into large-scale, multi-centre, multi-arm clinical trials against COVID-19).