13 Examples of Problems or Events that Require Prompt Reporting Adverse Events or Adverse Effects: Internal adverse events determined by the investigator to be unanticipated and related to the research External adverse events determined by the investigator, sponsor, coordinating center or DSMB/DMC to represent an unanticipated problem (i.e., unanticipated, related, and increased risk of harm) Changes to the protocol made without IRB approval to eliminate apparent immediate harm to subjects Unanticipated adverse device effects
{}