The conflict in Eastern Europe caused an uninterrupted influx of Ukrainian immigrants to Poland. Some of them started their participation in clinical trials before the war began.
The focus of the medical community is now on the interests and well-being of these patients. A number of Polish clinical study sites enrol Ukrainian patients in clinical studies, thereby giving them an opportunity to continue treatment in Poland. Taking this into account, GCPpl, POLCRO and INFARMA have recently developed a set of common guidelines and good practices for such entities.
The authors of the document stated that: “Joint activities must be undertaken to allow clinical study subjects to continue their participation in the studies, including the access to innovative therapies in the studies conducted in Poland. The war in Ukraine and the current dramatic situation require us to take quick and extraordinary measures.”
In order for Ukrainian patients to be enrolled in clinical studies in Poland numerous procedures have to be followed, for example necessary documents have to be translated into such patients’ native language. In order to be able to participate in a study, each patient must once again sign an informed consent form (ICF). The study sponsor is obliged to guarantee relevant language versions of any documents intended for Ukrainian patients. Significantly, the content of these translations has to correspond with the content of the Polish language versions previously approved by ethics committees and the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products.
“Having reviewed the available information, medical records, patient data as well as the risks and expected benefits, the investigator declares his/her readiness to enrol a patient in a study and to treat him/her at the study site in Poland. However, the sponsor’s decision to transfer the patient from Ukraine and to continue administration of the investigational medicinal product is equally important. Therefore, both the investigator and the sponsor take responsibility for the decision to enrol a patient in a study. The decision-making process involves clear and fast communication. In this way the safety of each clinical study subject can be ensured.”
KONTEKST provides translations of documents required for the commencement and conduct of clinical studies (e.g. ICFs), which are certified by sworn translators. We also offer certification of texts provided by the client, which allows accelerating the process of confirming documents’ conformity.
According to the guidelines, specialist translation or interpretation may also be needed at the later stages of the study. “It should be discussed with the Investigator/site whether an external interpreter will be needed during the patient’s visit and to what extent the site needs the support of the sponsor/CRO.”
We provide interpretation services during patients’ visits by an interpreter of Ukrainian as well as Russian. Our interpreters have expertise in the field of medicine and are educated in this specialty.
In response to the needs of our business partners, we facilitate effective communication and make it possible for documents to be used in another legal environment. Please read the full list of services provided by KONTEKST.
