Table 2. Examples of common sources of RWE for postmarketing safety monitoring^{2 4 5 35}.

Source of data	Examples
Spontaneous reports of ADRs	National or regional spontaneous reporting databases Global spontaneous reports databases
Electronic health records	Specialist ambulatory care records Databases for healthcare systems Primary care medical records Pharmacy dispensing records Hospital inpatient, outpatient and/or discharge records Emergency care records
Administrative data on healthcare service/claims	Administrative healthcare claims databases Diagnostic tests and procedures reimbursement records Exemption from co-payment exemptions
Observational cohorts (with collection of primary data)	Postauthorisation safety studies (PASS) or postauthorisation effectiveness studies (PAES) Biobanks (with prospective follow-up)
Disease/condition-specific registries	Disease registries Cancer registries Pregnancy registries Congenital anomaly registries Death registries
Drug/device registries	Drug registries Medical device registries
Patients	Patient-reported outcomes: Health surveys or questionnaires Interviews and/or focus groups registries Patient-generated health data: Wearable medical/personal devices o Mobile applications Social media Internet-based tools
Healthcare professionals	Survey of prescribers Chart review Clinical audit

ADR, adverse drug reaction; RWE, real-world evidence.