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Clinical Trials—Data Reconciliation

After case report forms have been filled out, data management personnel must reconcile the data. Data reconciliation is the process of validating, clarifying, and correcting reported data. In order to identify any discrepancies and missing data, data management must carefully monitor the data. Their tasks may include:

  • Generating and resolving queries on clinical trial data
  • Communicating with sites to obtain clarification on data when required
  • Identifying problems in the query/discrepancy management process and making recommendations for improvement

The number of data discrepancies and the amount of time sites take to respond to requests for data clarification affect site performance. Frequent and regular communication on the part of data management with the staff responsible for analyzing the data helps to improve data quality and reduce the number of queries. Fewer queries mean less time and money spent, thus contributing to the success of the clinical project as a whole.

Queries and Electronic Data Capture

Queries are created for discrepant or missing data when data management identifies data problems that cannot be resolved through the procedures established in the protocol. Queries identify the data that must be corrected, clarified, or verified.

Replacing paper query management systems with electronic data capture reduces the number of queries generated. If data verification is built into the electronic forms with edit and logic checks, the number of queries drops significantly.