Imaging Charter Development

An imaging CRO’s expertise in trial design and acquisition protocols can be instrumental in reducing a study’s size, duration, and overall cost.  WorldCare Clinical guides sponsors in designing an appropriate Independent Imaging Review Charter (Imaging charter, for short) for submission to the FDA. This document is typically a part of an image preparation and submission guide, developed before the study begins. Together, these documents specify a standard manner for acquiring, managing, and assessing images to ensure that data from multiple imaging sites is collected consistently.

The imaging charter provides details of how reading interpretations will be executed with the central reviewers and documents how the reader(s) will be qualified and trained, and how response criteria are to be used. The charter serves as the official record of the central reading processes and it is recommended that this document is submitted to the FDA for approval prior to the start of any central reads.