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    Clinical & TrialsClinical EvidenceSDV

    Source Data Verification

    Process of comparing data in case report forms against original source records.

    Reviewed by Christian Espinosa, Founder, Blue Goat CyberLast reviewed May 5, 2026

    Definition

    SDV is a quality activity where monitors verify that data captured in eCRFs accurately reflect source documents (typically the EHR, lab reports, or paper records).

    What this means in practice

    Risk-based monitoring approaches under ICH E6(R3) reduce the volume of SDV in favor of targeted verification of critical data and processes.

    Cross-references

    Uses

    Concepts or artefacts this term builds on.

    Primary references

    3 sources
    Link health: 3 verified· last checked 2026-05-09
    ICH·2ISO·1
    1. 1
      ICH E6(R3)
      Verified
      ICHdatabase.ich.org
    2. 2
      ICH Guidelines
      Verified
      ICHich.org
    3. 3
      ISO 14155 Standard Page
      Verified
      ISOiso.org

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