Why Query Management is Essential for Quality of Clinical Trial Images

When selecting an imaging technology solution, sponsors and CROs often focus on core capabilities like opening DICOM images, workflow management, and electronic case report forms. Query management allows communication between individuals performing quality assessments and management of the trial, and sites are often overlooked. Queries are important because they are commonly used to convey image quality issues and changes to the site, racking them through to resolution for regulatory purposes is also necessary. Queries also alert when patient images are overdue, ensuring proactive follow-up so no image studies are missed by the site.

Image quality query rates of all clinical trial images submitted on a trial can run as high as 20% or more. When overdue exam request queries are included, this figure can exceed 50%. Imaging solutions often have disparate and manual query solutions, which may require sites to follow procedures that are different from all other imaging tasks. In addition, when queries are issued to sites, the description of the issue is often manually generated, introducing variations in the query text. In addition, having disparate, error-prone query management tools like Excel or email can lead to lost query responses and a lack of regular follow-up. In addition to causing frustration with sites, these errors can have severe consequences. For example, imaging cases with unresolved quality issues can prematurely slip through to independent review. This can lead to unevaluable data which has an impact on imaging endpoints, or re-review of images by a radiologist which increases time and cost.

A well-designed, unified technology solution allows queries to be tracked in the same system where clinical trial images are collected, QCed, and reviewed. This ensures that the complete history of a subject’s visit is available. This successful technology should include:

• Automated overdue queries: Allowing automated overdue visit queries to be issued to the site saves users from having to manually identify and create queries when an imaging exam should have been acquired but has yet to be submitted.
• Automated query resend: Allowing users to configure automated query follow-ups for unresolved queries. This saves users from having to manually identify when a query has not been addressed on a predetermined frequency and also saves users the hassle of having to locate those queries and re-issue them manually.
• Customizable query categories with pre-defined query templates: Allowing users full flexibility to define common query categories, with predefined text associated with those categories. This ensures a consistent description of common quality issues regardless of who issues the query. The pre-defined query text also allows users to modify text for an individual query if needed, giving users full flexibility. This saves them a significant amount of time when writing queries, and provides a more consistent message to the site.
• Preventing cases from proceeding if a query exists: When queries are disparate from the imaging solution, it allows cases to prematurely proceed to independent read. It’s critical that all queries for a visit are resolved before that case goes to independent review. The solution should have a stop gap feature that prevents users from moving a case to independent review unless all queries have been resolved. This can be configured as a hard stop, meaning the case is not allowed to proceed at all, or a soft stop, which allows the user to override this edit check with a comment, if required.

Medidata’s Rave Imaging is the right technology to help you control and manage your images in clinical trials, including advanced query management to alleviate all your query challenges. Learn more here.