Updated Guidance on the Management of Clinical Trials during the Covid-19 (Coronavirus) Pandemic

On 28 April 2020 the EMA updated the Good Clinical Practice guidance on distributor to trial participant IMP shipment, monitoring, remote source data verification and communication with authorities.

The guidance is available for clinical-trial sponsors on how they should adjust the management of clinical trials and participants during the COVID-19 pandemic. This updated guidance (version 3) 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.
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