Key Intelligence Topics (KITs) and Key Intelligence Questions (KIQs) in safety signal intelligence

摘要

Key Intelligence Topics (KITs) and Key Intelligence Questions (KIQs) are routinely used in various intelligence endeavors. This presentation will explore their application to cross‐functional signal intelligence in a biopharmaceutical company. We will describe the rationale for choosing the KIT/KIQ approach, highlighting some of the key challenges shared across traditional intelligence and safety signal intelligence. Our methodology for implementing a KIT/KIQ process across Safety, Product Complaints and Medical Inquiries will be described in detail. We will also share results of early work to visualize and analyze cross-functional data. Future work on cross-functional governance and approaches to question management will also be discussed. These topics are relevant to preserving corporate memory and enabling collaborative collection, analysis and production of intelligence products.