What is a clinical data query and when should it be raised?

Why

Suppose a visit date precedes the recorded consent date. The electronic data capture system can flag the inconsistency, but a site investigator or authorized source owner must establish whether the date is wrong or the visit was genuinely early. A clear query cites the affected field and discrepancy without suggesting an unverified answer.

Apply risk-based triage so critical endpoints, eligibility and safety issues receive appropriate urgency. Keep the original entry, responses, edit reasons, user identity and timestamps in an audit trail, then verify that corrections resolve the discrepancy without creating another. Automated checks can identify patterns but do not replace medical interpretation.

Avoid pressuring sites to revise plausible outliers solely to match expected ranges. Regulatory expectations depend on applicable protocol, data handling plan and GCP requirements.