Which list should be provided to support communication with sites regarding late data and queries?
Correct Answer: D
Effective site communication in data management relies on transparent reporting of pending issues such as open queries, missing data, and overdue updates. According to the Good Clinical Data Management Practices (GCDMP, Chapter: Communication and Metrics), the list of outstanding data and queries by site provides a direct, actionable overview of what each site needs to address, supporting accountability and timely resolution.
This list typically includes subject identifiers, query types, dates generated, and status of resolution, allowing data managers to prioritize site follow-ups. Regular distribution of this report fosters efficient collaboration between the data management team, monitors, and site staff, ultimately improving database cleanliness and timeline adherence.
Options A and B reflect general study status but do not target data issue resolution. Option C pertains to user access oversight, not data progress. Hence, option D is the correct and most operationally relevant answer.
Reference (CCDM-Verified Sources):
SCDM GCDMP, Chapter: Communication and Metrics, Section 5.2 - Site Reporting and Query Management Metrics ICH E6(R2) GCP, Section 5.18 - Site Oversight and Communication Requirements