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Czech drug authority recommendations on clinical trials

Czech Republic
06/04/2020
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The Czech State Institute for Drug Control (SUKL) recently published its opinion on ongoing clinical trials and clinical trials that have not yet started in light of the COVID-19 situation.

With the exception of clinical trials of products for the treatment or prevention of COVID-19, SUKL strongly discourages beginning newly authorised clinical trials and the enrolment of new trial subjects into ongoing clinical trials.

SUKL also recommends:

  • double-checking the situation of trial subjects in advance by phone (i.e. to determine if the trial subject is in quarantine, if he is not confirmed to be infected with COVID-19, if he does not share a household with a quarantined person, etc.);
  • where possible, changing the physical examinations of trial subjects to remote check-ups in order to ensure their safety or due to closed healthcare facilities. Remote check-ups have to be duly documented and they need to include necessary reasoning (i.e. a referral to the current situation);
  • providing healthcare staff and trial subjects with personal protective equipment, especially in case of immunosuppressed patients. The sponsor of the clinical trial should provide the protective equipment;
  • during an emergency, sending study medication to trial subjects by courier service. As an alternative, a family member of a trial subject could deliver the study medication if the trial subject previously notifies the investigator. The investigator would have to record this arrangement in the trial subject's documentation;
  • any communication to inform trial subjects or to obtain a subject’s informed consent should be conducted remotely by phone or email. The communication needs to be acknowledged and duly recorded.

In case of a return of the study medication, SUKL requires that trial subjects keep the unused study medication and return all medication for control purposes and all used and unused study medication to the investigator personally after the end of the state of emergency. The investigator will duly record this return.

For more information, contact your regular CMS advisor or our local CMS experts.

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