| The informed consent form (ICF) is part of the patient information. The ICF is used to document in writing that a patient agrees to the participation in a certain clinical trial after having been comprehensively informed about the trial by the investigator and after having received satisfactory answers to all their questions. The patient may revoke their consent at any time without this resulting in any disadvantages for them (§ 40 sec. 2 Medicinal Products Act). In addition to the patient, the investigator uses the ICF to confirm that they handed over the patient information to the patient, that they informed the patient comprehensively and that the patient understands the study’s contents (nature, risks, benefits). |
Deutsche Erklärung |
