Workflow of quality control in multi-center clinical trials

Learning Objectives To introduce the individual components necessary for appropriate quality control of imaging studies in multi-institutional clinical trials to educate investigators and potential investigators on how to integrate appropriate quality control components in their clinical trial design.

Summary: Stringent quality control is critical component of any imaging clinical trial to assure the appropriate execution of the trial design in order to firmly achieve the goals of the trial. Quality control needs to be integrated in the conceptual design, in the pre-qualification of the environment, in the ongoing management of the trial. Frequently quality control is also neglected in the post-processing and post trial assessment which is essential to eliminate bias in other non-intended potential error sources. The presentation will use real case examples that help understand the components as well as problems or challenges arising at the different steps of the quality control process. The presentation is intended to serve as a refresher for current investigators and as a "how to" introduction for potential investigator