Monitoring
Risk-based SDV
Source data verification is an independent status axis, not a wizard step.
SDV is an axis, not a stage
Verification is an independent status of every value: a signature does not require completed SDV, and editing a verified value resets the mark automatically. Status is computed from coverage, not toggled by hand.
The risk-based approach
ICH E6(R2) established risk-based monitoring: verify what is critical rather than everything. The monitor verifies by field and form; coverage is visible per subject and visit.
A discrepancy becomes a query
A discrepancy with the source documents turns into a query right at the field; the conversation and deadlines live in the shared query registry.
Next — in the documentation: Verification (SDV)Casebook and visits
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