Query Management: What is it?
A query is a communication tool used in the clinical trial process to clarify or resolve any discrepancies or inconsistencies found in the data. After all, while clinical trials are important in advancing scientific discovery, they are only as valuable as the quality of the data they produce.
Query formation, management, and resolution
Queries are generated during validation checks by the sponsor or on behalf of the sponsor. These queries are then forwarded to the site that is responsible for either clarifying a detail or correcting an error. Once the query is addressed and completed, the information is resubmitted to the sponsor for entry into their database.
Traditionally, queries were created during on-site visits when clinical research associates (CRAs) or clinical trial monitors (CTMs) would painstakingly go through all of the source data, case report forms (CRFs), and other paperwork to check for consistency, completion, and any possible errors. Any discrepancies were then tracked using large spreadsheets and had to be manually checked to ensure they were resolved prior to being updated to a completed status. While it was vital for the clinical trial process, it was largely inefficient, expensive in terms of resources and time, and inconsistent because it relied heavily on the skills of the individuals doing this verification, which was not standardized between all sponsors.
Some evolutionary advancements in the process have included transferring the data directly from equipment such as blood pressure and blood sugar monitors and recruiting more than one sponsor representative to enter the data from the paper forms into a centralized database. The database software that is used is often designed to pick up inconsistencies in this data – such as an unlikely date of birth for a patient and/or values incompatible with life – and flag the discrepancies to the attention of the site staff for a manual recheck. However, due to both human and technological inaccuracy, the need for consistent verification and in person on-site visits is often still needed.
Now, with further modern-day digitization of the data management process, query management can be further simplified and used to improve the trial process. This is being done through implementing automation at several steps:
- Entry of initial data into a centralized database and digitized forms, such as eSource and eCRF.
- Targeted monitoring of data instead of verification of all data.
- Consistent use of electronic data capture systems (EDCs).
- Data transfer integration of electronic health records (EHRs) that allow for automated source checks.
- Ability to access data in near real-time without an immediate need for an on-site visit, making validation checks and monitoring for patient safety faster.
- Use of wearable devices and biosensors.
- Use of AI and data science software to check for errors, discrepancy trends in individual sites, and outliers indicating potential adverse effects.
- Automated tracking of the status of the query and resending as needed.
- Preventing cases from moving forward if there are unanswered queries.
What are the characteristics of a good query?
The most important characteristic of a query is clarity. The site staff should be easily able to understand what clarification is needed and why. An ideal query should identify what type of issue is at hand, where the potential data error lies, and prompt the user for action with simple instructions.
However, a query should not provide a specific answer to resolve the discrepancy in question. For example, a query could be made for a blood pressure entry of 4000/1000, which is not compatible with life. While the query should flag this inconsistency and provide instructions to verify the data, such as performing a manual re-check and calibrating the blood pressure monitor, it should not direct the staff to change the measure to a specific value, such as 120/80.
What are the benefits of queries?
- Ensuring compliance with the protocol.
- A completed collection of data.
- Assessing validity and quality of data being collected at each trial site.
- Ensuring patient safety.
- Getting ahead of further errors.
- Ensuring successful regulatory audits.
What are the limitations of queries?
Queries should ask for specific information so that they can be resolved or answered quickly. However, queries, especially those created through auto-checks, cannot replace the need for site visits and manual checks. The resolution of queries often depends on the site staff, and thus requires that there is clear and frequent communication between the data management team and the trial sites.
Conclusion
Query management is a vital part of the clinical trial process, playing an important role in ensuring compliance with protocol and regulatory requirements, data accuracy and validity, trial efficiency, and patient safety. While the process has historically been inefficient and expensive, new digital solutions and centralization of the data management can help clinical trials produce life-changing solutions at a lower cost in time, personnel, and money.
