When imaging is part of a clinical trial, two unique documents must be developed to ensure the quality and efficiency of that imaging. The Imaging Review Charter is one of them.
What is an Imaging Review Charter?
A Charter is a regulatory document drafted to define and describe all aspects of the procedures that an imaging core lab follows when processing image data and conducting the independent read. It might consist of a single document or a series of documents. In either case, the Charter should describe the clinical trial imaging methodology, including modality-specific technical details, image interpretation, and image archiving procedures.
Considered to be the de facto guide or handbook for the management and reading of all images, the Charter is critical for Phase 3 studies and highly recommended for earlier phase studies as well. In an effort to help define and shape the Charter, and other considerations surrounding imaging in clinical trials, the US FDA issued multiple guidance documents on the subject starting in 2004. The most recent, entitled “Clinical Trial Imaging Endpoint Process Standards Guidance for Industry,” was released in April 2018.
What Does an Imaging Review Charter Bring to a Clinical Trial?
The Charter describes in detail the read design and the methodology followed. It is, therefore, key to understanding how imaging endpoints are assessed and how results are obtained.
All procedures followed during the process of collecting image data and the independent read are described in the Charter. Essential details contained include . . .
- How images are received, handled, and stored
- How quality issues are identified, managed, and resolved
- How readers are trained and assigned
- How and how often central reads are carried out
- How and how often data are handled, stored, and finally transmitted to the sponsor and CRO.
How is the Imaging Review Charter Developed?
The Charter is developed during the startup phase of a clinical trial in order to ensure everyone is on the same from beginning.
When sponsors and CROs work with us at Keosys, we write the first draft. The CRO/sponsor then reviews the document, adding comments and questions. Finally, a review meeting is held to discuss all issues and concerns. The final Charter emerges from this meeting. Once all parties have signed off on it, the groundwork is in place for consistent, high-quality imaging and image management.
Get the guidance you need from Keosys
Creating Charters is among the many services that Keosys provides to enterprises and institutions using medical imaging in clinical research. Let us know how we might help you and your team.