Queries & Discrepancy Management

Query lifecycle, site communication, discrepancy logs, and closure quality.

19 terms

Critical Query

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

Data Clarification Form

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

Non-Critical Query

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

Query

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

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Queries & Discrepancy Management

Query lifecycle, site communication, discrepancy logs, and closure quality.

19 terms

Critical Query

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

Data Clarification Form

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

Non-Critical Query

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

Query

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

Query Aging

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

Query Lifecycle

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

Query Prioritization

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

Query Writing Tip: Ask one question per query

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

Query Writing Tip: Avoid leading language

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

Query Writing Tip: Avoid yes/no when a value is needed

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

Query Writing Tip: Close the loop with expected action

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

Query Writing Tip: Escalate overdue critical queries

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

Query Writing Tip: Explain impact for critical items

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

Query Writing Tip: Include timeframe or visit

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

Query Writing Tip: Provide precise field references

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

Query Writing Tip: Request source confirmation when needed

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

Query Writing Tip: Use polite and clear tone

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

Self-Evident Correction

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

Site Communication Log

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