The most effective method forquality control (QC)of the query resolution process is toperform random audits of resolved query forms. This ensures that queries are being appropriately raised, addressed, and resolved in accordance with the study protocol, data management plan (DMP), and standard operating procedures (SOPs).
According to theGCDMP (Chapter: Data Validation and Cleaning), QC activities should verify that the data review and query management process maintains high accuracy and consistency. Random auditing of resolved queries enables verification that:
Queries were raised for legitimate discrepancies,
The site’s responses were appropriate, and
The resolution actions taken by data management were correct and well-documented.
Metrics such as turnaround time (options A and C) or query counts (option B) measure efficiency butdo not assess quality. True quality control focuses on ensuring that data corrections preserve accuracy, auditability, and traceability — the fundamental principles ofdata integrityin clinical research.
Reference (CCDM-Verified Sources):
SCDM Good Clinical Data Management Practices (GCDMP), Chapter: Data Validation and Cleaning, Section 5.4 – Query Management and Quality Control
ICH E6 (R2) GCP, Section 5.5.3 – Data Integrity and Validation Procedures
