Extraordinary measures for clinical trials due to COVID-19

13 March 2020, Updated 02 July 2020

We have updated our guidance extraordinary measures for clinical trials due to COVID-19 to version 6.0.

Version 6.0 of this guidance includes the following updates:

  • Introduction: Adjusted to current conditions. The initial response time for CTAs adjusted to 10 work days.
  • Section 2.3 updated: Deadline and notification requirment updated.
  • Section 3.2 updated: Expectations of rSDV amendments added.
  • Section 4.4 added: Precision that shipment of IMP directly from site is allowed if complying with our Q&A.
  • Section 5.3 updated: Activity in FiH trials adjusted to current conditions.
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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