On-site monitoring is sometimes seen as a formality: check, tick, sign. In reality, attentive site follow-up contributes directly to data reliability — and therefore to the scientific value of a study.
Verify, but above all understand
Source data verification (SDV) is not just about comparing numbers. It is about understanding how data is generated, documented and reported in the field. It is in that understanding that inconsistencies and deviations are spotted before they take hold.
Supporting investigator teams
A well-supported site produces cleaner data. Taking the time to explain the protocol, clarify expectations and answer questions avoids many later corrections.
The CRA's role is also educational: conveying the study's requirements clearly, without unnecessary jargon.
Anticipate rather than correct
- Identify friction points in the data flow early.
- Document deviations and follow up on corrective actions.
- Maintain regular communication between the site and the sponsor.
Anticipating always costs less than correcting at the end of a study, at database lock.
Quality is built over time
Data quality is not a final check: it is built visit after visit, through regular follow-up and constant attention. That is where rigorous monitoring shows its full value.
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Source: ICH E6(R2) Good Clinical Practice — data verification and risk-based monitoring. Last updated: November 2026.