Which list should be provided to support communication with sites regarding late data and queries?

To facilitate communication with clinical sites about pending work, the most effective tool is a clear, actionable list of what is outstanding. A list of outstanding (late/missing) data and unresolved queries provides site personnel with a specific "to-do" list. This allows them to efficiently locate and address the exact data points and queries requiring attention, which is a fundamental practice for ensuring data timeliness and quality in a clinical trial. This type of report is a standard component of site management and monitoring activities within clinical data management.

A. A list of entered and clean data shows completed work, not what is pending. It is a measure of progress, not an action list for outstanding issues.

B. A list of screened and enrolled subjects tracks recruitment metrics, not the status of clinical data entry or queries for those subjects.

C. A list of user account activity is used for auditing system access and security, not for identifying specific missing data or unresolved clinical queries.

1. Society for Clinical Data Management (SCDM). (2023). Good Clinical Data Management Practices (GCDMP). Section 6.6, "Query Management," outlines the process which includes tracking, managing, and resolving data discrepancies. Reporting on the status of queries (i.e., which are outstanding) is an integral part of this process for communication with sites.

2. Prokscha, S. (2011). Practical Guide to Clinical Data Management. CRC Press. Chapter 12, "Managing the Data Flow," discusses the use of status reports, such as missing pages reports and query status reports, which are provided to sites to monitor and prompt action on outstanding items (pp. 165-167).

3. Krishnankutty, B., Bellary, S., Kumar, N. B. R., & Moodahadu, L. S. (2012). Data management in clinical research: An overview. Indian Journal of Pharmacology, 44(2), 168–172. This article describes the data validation process, stating, "Discrepancy management is the process of resolving the errors... A list of discrepancies is generated and sent to the investigator for clarification." (p. 171). This directly supports providing lists of outstanding items. https://doi.org/10.4103/0253-7613.93842