Adverse Event Monitoring and Management

  • develop an out-of-range/notable laboratory value tracking sheet for each subject for easy investigator reference for trends, changes, and recent ranges. This tracking sheet also includes AE/SAE values for the study to ensure no adverse events went undetected.
  • apply pharmacological knowledge to assist the investigator in determining idiosyncrasies, causality, expected and/or unexpected results.
  • observe, query, and document medical events (adverse events).
  • present principal investigator with relevant information for determination of seriousness, causality, classification, and intervention.
  • act on principal investigator’s recommendation for adverse event intervention (e.g., stop test article, call subjects, retest, treat).
  • maintain follow-up to determine resolution of adverse event.
  • report serious adverse events to sponsor; and record adverse events and relevant information on source document, CRF, and sponsor specific forms.