adverse event process An adverse event process is a processual entity occurring in a pre determined time frame following administration of a compound or usage of a device I included the usage of a device into the definition of adverse event as I am aiming at being inclusive, and cover cases such as those described by MAUDE - Manufacturer and User Facility Device Experience. See for example http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1942591 - a patient get fitted with bioprosthetic heart valves and dies within the following 4 months. Note that this definition of adverse event doesn't imply any type of causality between the sign observed and the coumpond administration/device utilization. For our purposes, we consider any type of sign presenting within a specific time frame after the coumpound administration/device utilization to be an adverse event. adding a material entity into a target administering substance in vivo