Queries & Discrepancy Management

A query impacting safety or primary endpoints; prioritized for rapid closure.

Structured document used when clarification cannot be captured cleanly in EDC.

A query about supportive/optional fields; may be deprioritized near lock.

A request for clarification or correction when data are missing, inconsistent, or implausible.

Time since query opened; used to track overdue items and site performance.

The states a query moves through (raised, answered, reviewed, closed/reopened) with controlled ownership and timestamps.

Triage to focus site attention on safety/endpoint-critical issues first.

A practical query-writing guideline: Ask one question per query. Improves site comprehension and resolution quality.

A practical query-writing guideline: Avoid leading language. Improves site comprehension and resolution quality.

A practical query-writing guideline: Avoid yes/no when a value is needed. Improves site comprehension and resolution quality.

A practical query-writing guideline: Close the loop with expected action. Improves site comprehension and resolution quality.

A practical query-writing guideline: Escalate overdue critical queries. Improves site comprehension and resolution quality.

A practical query-writing guideline: Explain impact for critical items. Improves site comprehension and resolution quality.

A practical query-writing guideline: Include timeframe or visit. Improves site comprehension and resolution quality.

A practical query-writing guideline: Provide precise field references. Improves site comprehension and resolution quality.

A practical query-writing guideline: Request source confirmation when needed. Improves site comprehension and resolution quality.

A practical query-writing guideline: Use polite and clear tone. Improves site comprehension and resolution quality.

Correction made by authorized staff when source clearly supports change, per SOP.

Record of key data issues discussed with sites outside the EDC query trail.