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 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 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.