FDA FAERS Adverse Events (E2B)
FDA_FAERSfree10 data-quality rules for adverse-event reports submitted to the FDA Adverse Event Reporting System (FAERS) in the ICH E2B(R3) format. Covers required safety-report identifiers, MedDRA-coded reactions, seriousness and report- type validity, drug role and country codes, date logic, and duplicate safety-report suppression. Use it to validate ICSRs before gateway submission.
Checks included (10)
Required ICSR Fields Present
Each ICSR must carry the safety report id, a patient, at least one reaction, and at least one suspect drug.
Safety Report ID Present(safety_report_id)
The worldwide unique safety report identifier must be present.
Receipt Date Present(receive_date)
The date the report was first received must be present for regulatory clock calculation.
Seriousness Is Valid(serious)
The seriousness criteria flags must be valid (1 = yes, 2 = no per E2B).
Report Type Is Valid(report_type)
Report type must be a valid E2B code (1 spontaneous, 2 report from study, 3 other, 4 not available to sender).
Drug Characterization Is Valid(drug_characterization)
Drug characterization must be a valid E2B code (1 suspect, 2 concomitant, 3 interacting).
Reaction Is Coded in MedDRA
Each reaction must be coded with a valid MedDRA term (PT/LLT) per the licensed MedDRA version.
Occurrence Country Is Valid ISO 3166
The reaction occurrence country must be a valid ISO 3166 country code.
Reaction Onset After Therapy Start
The reaction onset date should not precede the suspect drug's therapy start date.
No Duplicate Safety Reports(safety_report_id)
Each worldwide unique safety report id must appear once per submission.