Terms related to detecting, validating, and evaluating safety signals
20 terms
A detailed clinical review of multiple individual cases sharing common characteristics to identify patterns and support signal evaluation.
A validated signal where evaluation has established sufficient evidence of a causal association requiring risk management action.
The application of statistical and computational techniques to large safety databases to identify potential safety signals automatically.
A communication sent directly to healthcare professionals to inform them of important safety information that may affect how they prescribe or use a medicine.