Case Definition Companion Guides
SPEAC’s Case Definiton Companion Guides support the use of Brighton Collaboration Case Definitions.
While a case definition provides standardized criteria for identifying and classifying a specific condition, the companion guide offers practical tools and resources to help apply it.
Together, the case definition and companion guide promote a consistent approach to vaccine safety monitoring across the vaccine lifecycle—from pre-authorization clinical trials to post-marketing studies and pharmacovigilance.
Each companion guide includes:
Background information to support understanding of the case definition
Resources to help identify and monitor the specific adverse event
Guidance on collecting relevant data
Tools for assessing the level of diagnostic certainty based on available evidence