Recent Development
On March 20, 2020, the Turkish Medicine and Medical Devices Authority (“TİTCK”) announced changes to clinical trial procedures to protect volunteers and researchers against COVID-19 .The TİTCK’s measures aim to reduce the workload of research centers and ensure the safety of volunteers.
What’s New?
The TİTCK requires sponsors to regularly conduct risk assessments, coordinate their clinical trial organizations and make updates when necessary. In this respect, the TİTCK states that sponsors must initially evaluate whether clinical trials should be temporarily suspended or terminated early, depending on the nature of the clinical trial.
If an event occurs that affects the safety of volunteers, sponsors or principal investigators must take the necessary emergency safety measures to protect volunteers. Accordingly, safety measures taken against the COVID-19 pandemic can be implemented without the Ethics Committee’s approval or the TİTCK’s authorization.
Sponsors or principal investigators may make changes to the monitoring activities during the clinical trials. In this regard, monitoring activities at the research center may be postponed and/or replanned. The TİTCK also allows remote monitoring if physical monitoring at the research center unfeasible, subject to the Law No. 6698 on Protection of Personal Data and the confidentiality principles of clinical trials.
In addition, the TİTCK allows investigational products and clinical trial supplies to be stocked for a longer period so that a sufficient amount of materials can be supplied to research centers in case of possible scenarios such as import restrictions or quarantine. The TİTCK also requires that volunteer visits to research centers be postponed when feasible, recommending telephone calls as an alternative.
The TİTCK stated that research meetings will be held online and it will not grant approval for face-to-face trainings or meetings regarding good clinical practices and clinical trials.
The TİTCK will not require physical documentation to be submitted for clinical trial applications and stated that the applications will be made electronically.
The TİTCK’s announcement on COVID-19 measures regarding clinical trials is available online here (in Turkish).
Conclusion
The TİTCK continues to take active steps to protect the public against the COVID-19 pandemic in Turkey. All sponsor companies must implement the TİTCK’s measures, conduct risk assessments and follow the TİTCK’s announcement in this regard.
