Every person taking part in a clinical study must sign an informed consent document. It includes information on the study, such as its goal, its duration, the required procedures and contacts.
The informed consent document also details the risks and the potential benefits following their involvement in the study. After signing the informed consent document, the participant will undergo several tests and answer questions about its medical condition to determine if he or she is eligible for the trial.
If the person is eligible for the trial and decides to participate, she will receive a treatment in accordance with the trial protocol and will be followed by the hospital at several defined moments of the study.