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About the RADARS System

General Characteristics of the RADARS System

Rate calculations

  • Population Rate
  • Unique Recipients of a Dispensed Drug (URDD)  Rate
  • Calculated per quarter or year, by Program

Geographic specificity

  • 3-digit ZIP code of patient or case
Product Specificity
  • Drug class (e.g. buprenorphine, oxycodone, hydrocodone, methylphenidate, etc.) 
  • Specific product (e.g. Suboxone®, Concerta®, Kadian®, etc.)
Reporting frequency to subscribers
  • Quarterly
  • Annually
  • More frequently by request
Signal determination methodology
  • Rate thresholds of 2- or 5- cases per 100,000 population
  • Conditionally autoregressive (CAR) statistical model with Bayesian hierarchical model specification (under development)
Quality Assurance
  • Document development and change control
  • Standard Operating Procedures (SOPs) for all Programs
  • Quality control steps including data entry verification, data validation, data verification, and final report verification
  • Database controls including validation, database backup and disaster recovery processes, and audit trails
  • Electronic systems controls including security and data transmission
  • Corrective action processes
  • Quality audits and monitoring, including database quality audits, monitoring visits at Program sites, internal audits, and contractor audits
  • Training program and documentation for all RADARS System staff
  • Central database 21 CFR part 11 compliant