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Monitoring and Quality Assurance

Monitoring and Quality Assurance

  • All Sponsor-Investigator studies are monitored for the following:
    • Protocol compliance and deviations
    • Informed consent
    • Adherence to GCP
    • Adherence to regulations, guidelines, and SOPs
    • IRB applications, approval notices, reports, correspondence
    • Conflict of interest/financial disclosure
    • Safety reporting
    • Pharmacy and investigational product (IP) accountability
    • Laboratory procedures
    • Training records
    • Site support
    • Adverse events (AE)/safety review
    • Essential document review
    • Source data verification (SDV)
    • Site performance assessment
    • Study progress against milestones

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