Extraordinary measures for clinical trials due to COVID-19

13 March 2020, Updated 09 October 2020

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.

Did you get answers to your questions?

Please tell us how we can improve our website? Please note that we do not answer questions asked via this feature.