You are covered by the insurance of the company developing the new treatment
Before a clinical study can be proposed to you by your treating physician, the study protocol and all product information was reviewed and approved by an independent “Ethics Committee”. An Ethics Committee is formed of scientific, medical and law/ethics experts that have carefully evaluated whether the potential benefit of this new treatment does not bear any risk or harm to the participating study patients. You can be therefore be reassured that everything has been thought to protect you against any hazard.
The study will be explained to you in detail by the physician, including the characteristics of the new treatment, and the analysis/examinations needed to be performed to assess the efficacy/safety of the treatment. The physician will be delighted in answering any of your question or addressing any of your doubt concerning the treatment or the examinations.
The data will be collected in an anonymised way, i.e. in such a way that your name will not appear in the data that will be given to the pharmaceutical company or to the health authorities. You will only be identified by a code and a number.
You will sign a written consent form as a proof that you have been fully informed about the study.
The decision to participate in the study belong only to you. You can withdraw from the study at any time, without giving any specific reason.
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