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Participation in clinical trials
Only individuals meeting the inclusion criteria specified in the study protocol may participate in clinical trials. Therefore, information about health status, past illnesses, and treatments is crucial in patient qualification. For each person meeting the criteria and expressing willingness to participate, the doctor conducts an informative interview about the program, possible benefits, and risks. The doctor answers all patient questions and concerns. After deciding to participate, the patient signs an informed consent form.
Safety of clinical trial participants
Participant safety is the primary priority throughout the entire clinical trial. This goal is achieved through the involvement of the entire medical staff consisting of doctors and a team of nurses.
The first stage of assessing the risk of participation in the study is a qualifying visit, during which a detailed interview is conducted regarding past and current comorbidities in terms of potential risks.
In the next stage, the participant undergoes a detailed medical examination to determine health status at the start of the study.
Throughout the study, there is the possibility to contact a doctor in case of concerning symptoms. During the patient’s stay at the center, a duty team consisting of a doctor and nurse monitors safety around the clock. During the study, it is possible to report ailments promptly and undergo a medical examination, as well as, in the event of an adverse event, perform appropriate additional tests and implement effective treatment. All adverse events are thoroughly recorded and immediately reported to the Study Sponsor.
Clinical trials are conducted in accordance with international guidelines and Polish legislation.
