| In accordance with § 3 sec. 2b GCP Ordinance, the investigator must conduct an informed consent discussion informing the patient comprehensively about the content of the trial, its benefit, risks and treatment alternatives before they may be enrolled in a clinical trial. Furthermore, the patient will receive the patient information which is written in a language that can be easily understood by laypersons. Apart from all information concerning the study, this information also points out that the participation in the study is voluntary and that the patient may revoke their consent to participation in the study at any time without giving reasons without having to fear any disadvantages for their future medical care. After having read this patient information the patient may take their time to think about whether or not they want to participate in the study. It is also helpful if the patient wishes to discuss a possible study participation with family or friends. If the patient should decide to participate in the study, they must sign the informed consent form, which is part of the patient information. |
Deutsche Erklärung |
