The most effective information for addressinga backlog of unresolved queriesat investigative sites is alist of late queries by site combined with a summary table.
According to theGCDMP (Chapter: Communication and Issue Escalation), timely and structured feedback to sites is critical for efficient query resolution. A detailed list oflate or overdue queries, accompanied by summary statistics (e.g., counts, durations, status), enables data managers and monitors to prioritize follow-up actions, target problem areas, and provide focused support or retraining to underperforming sites.
While query count summaries (option B) are helpful for overview metrics, they lack the specific information (query ID, date, field, status) required for targeted follow-up. Graphs of enrollment or clean cases (options A and C) are unrelated to discrepancy resolution performance.
Thus, the combination ofdetailed lists and summarized performance metricsoffers both granularity and a high-level overview — the optimal tool for query management communication.
Reference (CCDM-Verified Sources):
SCDM Good Clinical Data Management Practices (GCDMP), Chapter: Communication and Issue Escalation, Section 5.1 – Site Query Management Reports
ICH E6 (R2) GCP, Section 5.18.4 – Communication Between Monitors and Sites
FDA Guidance for Industry: Oversight of Clinical Investigations – Risk-Based Monitoring, Section on Query Metrics and Site Performance Review
