An Imaging Charter Contents Checklist

As medical imaging expands in clinical trials, the imaging charter has become the de facto handbook for how every image is managed and read.

An imaging charter is critical for Phase 3 and highly recommended earlier.
Use this checklist against your charter to confirm key coverage.

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Defining an imaging charter (from the FDA guidance)

A charter can be a single document or a series of documents, attached to the clinical protocol as an appendix or standing alone as an overarching summary that references imaging-specific documents such as acquisition protocols, data transfer plans, and image submission guidelines.

“An imaging charter… can consist of either a single document or series of documents. The charter should describe the clinical trial imaging methodology, including modality-specific technical details, image interpretation, and imaging archiving procedures. Sponsors should develop the document or documents with the same rigorous standards typically applied to the clinical protocol.”

— U.S. FDA, Clinical Trial Imaging Endpoint Process Standards: Guidance for Industry.

1

Executive Summary of the Trial Design and the Role of Imaging

Summarize the role of imaging within the clinical trial. Describe the imaging database variables (deliverables) to be incorporated into the analysis of the primary endpoint. Address important trial design features that might affect the proposed imaging database variables. Provide an overview of the major aspects of image acquisition, interpretation, and reader-defined deliverables.

2

Standards for Image Acquisition

Vendor-specific equipment and platforms (e.g., injectors, scanners, ultrasound probes, software). Equipment technical settings to be used at each site. Role of site imaging technicians in equipment operation, including identifying faulty or unacceptable images and the importance of repeating imaging. Phantoms to be used for site qualification and image-quality monitoring. Subject preparation, positioning, and comfort measures. Schedule for imaging, and alternatives. Off-protocol imaging. Imaging risks. Site qualification process. Acquisition quality-control monitoring process. Data storage and transfer.

3

Imaging Drug Standardization

Depending on the nature of the imaging evaluation, the charter should identify the important aspects of drug selection, dosage, and administration for each of these:

Preparative drugs. Contrast agents. Radiopharmaceutical agents.

4

Standards for Image Interpretation

Selection of images for interpretation, display sequence, and randomization. Verification of image technical adequacy. Transfer of images and supportive information to the centralized facility. The centralized facility’s process for querying sites for missing images, data, or technical problems. Obtaining repeat images of subjects. Logging of images received at the centralized facility, including the subject-specific tracking system. Formatting for image data transfer. Digitization of received images or data. Any technical evaluation (pre-interpretation) or alteration of images, including de-identification of subject information, biasing marks, or other undesired image signals. Monitoring compliance with the transfer, receipt, and initial image-assessment process. Correction of deficiencies and failures in the transfer, receipt, or initial image-assessment process.

Readers and their background qualifications

The extent of technical knowledge essential to image interpretation. Avoidance of any other reader involvement in the trial (e.g., as an investigator) that might bias interpretation. The importance of confidentiality of image reads and the reading process. The potential for reader fatigue and the use of substitute readers. (Reader fatigue is a documented cause of decline in interpretation quality, per Krupinski, Berbaum, et al., 2012.)

Reader training qualification

An overview of the major goals of image interpretation. An overview of expectations for image manipulation, lesion measurement, and other evaluations. Identification of any unique read definitions and criteria, including image case report forms. Description of any reader retraining procedures.

Interpretation process

Timing of image reads and the read process. Imaging case report forms. Imaging data-lock process. Quality control of the image display and interpretation process.

5

Charter Modifications Before Imaging

Imaging data-transfer process to the sponsor. Archiving of images and image interpretations. Verification of fidelity of charter documents with the clinical protocol and statistical analysis plan.

This checklist is adapted from Appendix A of the U.S. Food and Drug Administration’s Clinical Trial Imaging Endpoint Process Standards: Guidance for Industry.

Building or reviewing an imaging charter?

Bracken’s consultants have worked inside imaging core labs and pharma imaging teams for decades. We can be a second set of eyes on your charter and vendor selection, or embed in your team to manage as much of the process as you need.

Work with Bracken