Extraordinary measures for clinical trials due to COVID-19

13 March 2020, Updated 02 April 2020

We have updated our guidance extraordinary measures for clinical trials due to COVID-19 to version 4.0.

Version 4.0 of this guidance includes the following updates:

  • Section 3 updated: Specified that remote source data verification (remote SDV) is not allowed in Denmark.
  • Section 4 updated: Opportunity to deliver IMP by Danish pharmacies added.
  • Section 5 updated: Section added regarding the use of qualified and trained personnel to administer the IMP and conducting other diagnostic tests at the study participant's residence.
  • Section 5 updated: Specified the importance of strengthened communication to trial participants during the COVID-19 pandemic.
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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