Renamed: FAR-based Facility Signal Detection Tool Previously: Post-market Surveillance Reports Signal Detection and Cluster Analysis.
Description
Need for proactive detection of quality signals in post-market surveillance reports using statistical process control and topic modeling to identify potential drug quality hazards and mitigate the associated risks.
Detailed example
Identifies problem clusters for the flagged signals in an objective manner for triage/review.
AI / analytics pattern
Natural Language Processing: AI that processes, interprets, and shares information in human language.
Automation level / stage
c) Deployed – The use case is being actively authorized or utilized to support the functions or mission of an agency.
Expected benefit
Identifies proactive quality signals and their associated problem clusters in an objective manner for triage and human review, helping prioritize resources on the higher risk issues and more complex problems.
Controls / human review
ATO: Yes; PIA: Not published
Data needed
Internal Field Alert Reports data from LSMV (FAERS tool)