Extraordinary measures for clinical trials due to COVID-19
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 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.