What should be done if the site continues to provide inconsistent data after several re-queries?

When a clinical site repeatedly provides inconsistent data despite several queries, it indicates a potential systemic issue, a misunderstanding of the protocol, or a lack of attention from the initial data entry personnel. The standard and appropriate procedure is to escalate the issue according to the communication or data management plan. This typically involves contacting a higher-level site contact, such as the Clinical Research Coordinator (CRC) supervisor or the Principal Investigator (PI), or involving the study's Clinical Research Associate (CRA)/monitor. Escalation ensures the problem receives the necessary attention from personnel with the authority to investigate and resolve the root cause, thereby maintaining data integrity and a professional relationship with the site.

A. Continue to re-query until the site changes the data: This is inefficient, can damage the relationship with the site by appearing harassing, and fails to address the underlying reason for the inconsistency.

B. Gently lead the site to the correct response: This is a serious breach of Good Clinical Practice (GCP) and scientific integrity. It introduces bias and compromises the validity of the study data.

D. Do nothing, the data will remain inconsistent: This is a dereliction of the data manager's duty. The primary goal of clinical data management is to ensure data is accurate, complete, and consistent.

1. Society for Clinical Data Management (SCDM). (2019). Good Clinical Data Management Practices (GCDMP).

Section 6.5.2, Query Management: This section outlines the lifecycle of a data query. It emphasizes a systematic process for resolution. When standard cycles fail, the process necessitates escalation as defined in the Data Management Plan (DMP). The DMP should pre-specify the escalation path for unresolved or aging queries, which typically involves the lead data manager, the CRA, and senior site staff.

2. Prokscha, S. (2011). Practical Guide to Clinical Data Management (3rd ed.). CRC Press.

Chapter 10, Data Review and Cleaning, p. 152: The text explains that if a data discrepancy cannot be resolved through the standard query process, it must be escalated. The author states, "Unresolved issues are escalated to the clinical monitor or project manager for resolution with the investigator." This confirms that escalation is the required next step.

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.

Section: Data validation, p. 170: The article discusses the data validation plan (DVP), which includes procedures for handling data discrepancies. It highlights the importance of a clear communication and escalation plan for resolving data issues with clinical sites to ensure the final data is "clean" and accurate. This supports the principle of escalating persistent issues rather than letting them remain or using improper methods to resolve them. https://doi.org/10.4103/0253-7613.93842