Organisation of Patient or Data and Safety Monitoring Advisory Boards in paediatric studies

Organisation of Patient or Data and Safety Monitoring Advisory Boards in paediatric studies

This service seeks to offer guidance on setting up paediatric Patient Advisory Board or DSMB (Data and Safety Monitoring Board) and manage its activities, which are crucial in paediatric clinical studies due to the unique ethical, physiological, and regulatory considerations involved in studying treatments in children. This uniqueness also necessitates specific skills and expertise from DSMB members and activities.