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 7.0.

Version 7.0 of this guidance includes the following updates:

• The validity of this guidance is extended until 01 December 2021. However, normal procedures must be re-established when the situation allows it (cf. section 2.3)
• It is emphasized in the document that remote access to source data (rSDV) is subject for substantial amendment application procedure (cf. section 3.2)
• Section 2.3 updated: Clarification that notification is not necessary when re-establishing standard procedures, if notification of the changes to the trial conduct have been submitted previously.
• Section 3.2 updated: proofread
• Section 4.3 updated: Specification of requirements for IMP shipments from site to trial participants. 

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.