Critical Query | PharmaBharat Tools

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Critical Query | PharmaBharat Tools

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Critical Query Data Clarification Form Non-Critical Query Query Query Aging Query Lifecycle Query Prioritization Query Writing Tip: Ask one question per query Query Writing Tip: Avoid leading language Query Writing Tip: Avoid yes/no when a value is needed Query Writing Tip: Close the loop with expected action Query Writing Tip: Escalate overdue critical queries Query Writing Tip: Explain impact for critical items Query Writing Tip: Include timeframe or visit Query Writing Tip: Provide precise field references Query Writing Tip: Request source confirmation when needed Query Writing Tip: Use polite and clear tone Self-Evident Correction Site Communication Log

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CDM Queries & Discrepancy ManagementCritical Query

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Data Clarification Form

Critical Query

Queries & Discrepancy Management

Definition

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

Example

Used in CDM operations to support consistent execution: Critical Query.

Common mistakes

Not documenting decisions and assumptions related to "Critical Query".

Inspector question

How do you apply "Critical Query" in practice and how is it evidenced?

cdmqueries-and-discrepancy-management