Being enrolled in a trial the risk of participation is covered by insurance. Details of the insurance will be given to you. According to GCP criteria ethical and legal requirements have to be followed. If there are any concerns from the ethical or legal institutions the trial can not be started. A data and safety monitoring board (DSMB) or data safety Monitoring Committee (DSCM) will supervise the trial. It is an independent group of experts monitoring the patient safety and treatment efficacy from the beginning to the end of the trial. The principal investigator has to send reports at regular intervals to inform them on all belongings regarding the trial. Severe adverse events (SAEs) and suspected unexpected severe adverse reactions (SUSARs) have to be send also to regular bodies. Stopping rules defined before opening a trial will be strictly followed and is one of the duties of the DSCM.
