Trial Information and Informed Consents
Informed Consent of Study Subjects
All subjects must give their voluntary informed consent before being able to participate in a clinical trial. The actual informed consent implies that subjects are given information about the trial well in advance, that they are also given an opportunity to ask questions relating to the study and receive understandable answers to their questions, so that they are able to decide on study participation based on information.
Study subjects are entitled to withdraw their consent at any time prior to the completion of the research, and they shall be informed of this right before study start. Withdrawal of consent and subsequent withdrawal from the study must not involve consequences for the study subjects, and it can't affect to their medical care or treatment.