A query is a clinical data management tool used to clarify discrepancies, missing values, or questionable data points in the study data recorded in the eCRF. When a data manager or an automated plausibility check (edit check) in the EDC system identifies a potential issue, a query is generated and sent to the responsible personnel at the study site.
The study site must respond to the query by either confirming the data, correcting it, or providing an explanation for the value. This process is repeated until the data is considered correct and plausible, allowing the query to be closed. Query management is a central process for ensuring high data quality. Efficient management aims to minimize the number of queries through sound eCRF design and clear instructions, while promoting rapid and precise responses from the sites.