Data handling should be performed how when a data query arises?

Data handling should be performed how when a data query arises?

• A. Archive it for later
• B. Send to sponsor for approval
• C. Ignore the query if it seems minor
• D. Resolve promptly and accurately

Answer: (D)

When a data query arises, the priority is to resolve it promptly and accurately. This approach keeps the dataset trustworthy and ensures that analyses, safety assessments, and regulatory submissions aren’t delayed by unresolved discrepancies. Prompt, precise resolution involves verifying the questioned data against source documents, making any necessary corrections or providing a clear justification, and recording the action taken in the query system for auditability. It also helps maintain data quality across the trial and supports timely database lock. Archiving the item, delaying resolution, or ignoring a query undermines data integrity and can lead to incomplete or inaccurate analyses, regulatory concerns, and potential safety reporting issues. While sponsors may be involved in escalation if policy requires, the standard practice is to close the query with the correct data and proper documentation as part of routine data management.

When a data query arises, the priority is to resolve it promptly and accurately. This approach keeps the dataset trustworthy and ensures that analyses, safety assessments, and regulatory submissions aren’t delayed by unresolved discrepancies. Prompt, precise resolution involves verifying the questioned data against source documents, making any necessary corrections or providing a clear justification, and recording the action taken in the query system for auditability. It also helps maintain data quality across the trial and supports timely database lock.

Archiving the item, delaying resolution, or ignoring a query undermines data integrity and can lead to incomplete or inaccurate analyses, regulatory concerns, and potential safety reporting issues. While sponsors may be involved in escalation if policy requires, the standard practice is to close the query with the correct data and proper documentation as part of routine data management.