Composition of the coordinating center and trial steering committee {5d}
ADVERSE EVENTS
The roles and responsibilities of stakeholders are clearly defined by Good Clinical Practice (GCP) regulations. Meetings of the sponsor, investigator, site manager, and study personnel for progress evaluation are scheduled monthly. In case of adverse events, non-adherence, or other occurring problems, an urgent meeting will be arranged within three days. Sponsor’s PhD student will organize communication to all parties and conduct trial management.