General Characteristics of the RADARS System
| Rate calculations |
Unique Recipients of Dispensed Drug (URDD) and population. Both are calculated per quarter or year, by Program |
| Reporting frequency to subscribers |
Quarterly, 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)
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| Geographic specificity |
3-digit ZIP code of patient or case
Coverage of 872 3-digit ZIP codes in the nation (98%)
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| Product Specificity |
Drug class (e.g. buprenorphine, fentanyl, oxycodone, hydrocodone, methylphenidate, morphine, hydromorphone, oxymorphone, methadone, tapentadol) and specific product (e.g. Suboxone®, Concerta®, Kadian®) |
| Quality Assurance |
- Document development and change control
- Implementation of 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, central database internal system data 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
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