Monitoring of investigational adverse drug experiences

A number of different facets of the task of monitoring adverse experiences in clinical trials of investigational drugs are considered. Key responsibilities of the monitoring process are identified as warning, observation, and management. The relationship of regulatory needs to organizational culture is reviewed. A number of specific areas of interest relating to the monitoring process are examined, including event capture at the investigational site, unblinding, and causality assessment. The importance of an independent quality assurance oversight of the adverse experience monitoring function is touched on, as is the essential role of data management in the functioning of the safety monitoring effort.