On April 20, 2020, the Turkish Medicine and Medical Devices Authority (“TİTCK”) published a Frequently Asked Questions (FAQ) document regarding the COVID-19 measures for clinical trials. The document is available online here (in Turkish).
The TİTCK prepared the FAQ document in response to questions about clinical trials during the COVID-19 outbreak. According to the TİTCK, if an event occurs that affects the safety of volunteers, sponsors or principal investigators would be able to enact emergency measures without the Ethics Committee’s approval or the TİTCK’s authorization.
The TİTCK stated that the remote source document review/verification procedures, which are part of the remote monitoring process, must be carried out in accordance with the Law on Protection of Personal Data and applicable secondary regulation. Accordingly, the sponsor/investigator must obtain the volunteers’ informed consent and take the necessary organizational and technical measures to ensure the protection of personal data.
Investigators can ship the investigational drugs to the locations determined by the volunteers, except those that require healthcare personnel to administer the investigational products. In this regard, sponsors may engage third party service providers (e.g. logistics firms) that operate in accordance with Good Distribution Practices for the shipment of investigational products.
The investigators can conduct volunteer visits for clinical trials at locations determined by the volunteer and the research team, such as a volunteer’s house or another research center or health organization (e.g. hospital).
Compassionate Use Programs (i.e. Early Access Programs) do not fall within the scope of explanations under the FAQ document. The relevant persons must contact the relevant directorate of the TİTCK to obtain information about these programs.
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, integrate them to their processes and conduct risk assessments.
Please refer to The Esin Attorney Partnership Coronavirus Helpdesk for our client alerts regarding the legal consequences of COVID-19 on other areas.