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Opinion of SUKL´s Department of Clinical Trials of Medicinal Products from the 22 November 202 will expire on the 23 May 2022.

We would like to inform sponsors, CRO representatives, and monitors that the Opinion of SUKL´s Department of Clinical Trials of Medicinal Products on ongoing clinical trials and pending clinical trials related to COVID-19 from 22 November 2021 will expire on 
23 May 2022
. Sponsors should return to the standard regime and should no longer apply for the emergency measures permitted by this statement.

With immediate effect, there is no need to comply with:

* The recommendation to always ascertain the trial subject's situation in advance by phone, the covid history can be taken during the visit of the subject.

* Recommended safety measures in the commencement of clinical trials with healthy volunteers or clinical trials without therapeutic benefit for the enrolled trial subjects. Sponsors may switch to the normal regimen of clinical trials.

 

29. April 2022

Department of Clinical Trials of Medicinal Products