COVID-19: Update on Clinical Research Precautions

Dicle Doğan and Fatma Sevde Tan, Gun + Partners

On 25 July 2020, the Turkish Medicines and Medical Devices Agency published an update to its announcement titled Precautions to be taken in Clinical Research due to the COVID-19 pandemic (Turkish language) that was originally published on 20 March 2020. The update reflects feedback collected from the industry.

The updated announcement states the following:

  • Applications to conduct online meetings between research personnel during the pandemic can now be made to the Agency five working days before the meeting, instead of 30 days.
  • Within the scope of clinical trials, face-to-face trainings may now be held online.
  • Increases in the number of volunteers and applications to add research centres are permitted, provided that the possible workload of research centres decreases with the normalisation process in which the government reduces measures taken in the fight against COVID-19.
  • An accelerated assessment procedure will be applied to applications regarding COVID-19-related clinical trials.

First published by Practical Law in 29.08.2020.

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