Extraordinary measures for clinical trials due to COVID-19

13 March 2020, Updated 24 April 2020

We have updated our guidance extraordinary measures for clinical trials due to COVID-19 to version 5.1.

Version 5.1 of this guidance includes the following updates:

  • Section 3 updated: Opportunity to establish remote access within certain conditions to source documentation added.
  • Deadlines in the document postponed to 01 September 2020.
We also include this version of the updated guidance with highlighted changes.

We are aware that COVID-19 has consequences with regards to the conduct of clinical trials in Denmark. Multiple factors play a role such as trial participants in quarantine, limited access to public places (including hospitals) due to the risk of spreading infections etc.

We prioritise all requests regarding COVID-19 and can be contacted per mail in case of questions related to clinical trials. Please mark any contacts clearly with ’COVID-19’ in the subject field. You can also contact our helpline (4488 9123).

The guidance regarding extraordinary measures for clinical trials due to COVID-19 will be updated continuously.

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