MRI is currently underutilized in multi-center clinical cancer Phase 2 and Phase 3 trials such as enabled through the National Cancer Institute (NCI) National Clinical Trial Network (NCTN) due to its perceived complexity and variability. The Imaging and Radiation Oncology Core (IROC) cooperative was formed with the reorganization of the NCTN and started to provide network wide services since 3/2014. IROC Ohio is one of six imaging corelab’s within the cooperative and focuses on supporting and managing NCTN trials for the Alliance and SWOG network groups. This team has made it an innovation priority to help facilitate the increased use of MRI within such trial and to develop best practices for quality assurance. While most quality assurance has been focused only on phantom based performance assessment of the MRI devices, we focus in this effort specifically of the patient imaging quality assurance aspects.We are the responsible imaging core lab team for a portfolio of innovative therapeutic clinical trials that use MRI for imaging based disease and therapy assessment. We specifically refer to the methodology development for imaging based QC for a trial that studies advanced rectal cancer in a broad, multi-center setting where “standard of care” (SOC) MR imaging is utilized. SOC is based on local clinical protocols that are and must be acceptable to local and institutional credentialing requirements including patient insurance carriers. Such a setting is quite different from the more specialized, trial specific imaging protocols typically used in smaller or earlier (Phase 1) clinical trial settings. The team that focused on the methodology development consisted of a broad range of experiences from MRI physics to clinical oncology to clinical imaging trial experts.Prior to the methodology approach mapping, an extensive review of potential learning points from prior imaging methodology quality assurance efforts such as the FNIH supported Oncology Biomarker Qualifying Initiative (OBQI) was performed. As a key finding, a DICOM image tag based semi-automated approach appeared to be the most desirable, objective and cost-effective methodology. Figure 1 sketches the key quality assurance process steps out. The two key starting points are A, the imaging or clinical expectations of the trial chair (PI) and B, the information obtained from site questionnaires to know what the reported local practices are. These enable the development of a DICOM tag based QC assessment matrix (C) (Figure 2) that can then be used for a QC master assessment template (D). Within such a template, the desired compliant parameter range (E) should be defined as well as the additional ranges that may be not desired but still acceptable and those that are beyond and such not acceptable (G). All those components facilitate a highly standardized and parameter driven semi-automated QC approach (F). Using a color schema (Green, yellow, red) for parameter heat mapping enables a quickly assessable performance overview that then allow for cluster based analysis of parameter compliance and help to spot issues that may be patient characteristic or site performance dependent. Site specific mapping can be an efficient quality assurance tool as many clinical sites do not even realize their variability and protocol variations within their clinic practice. Therefore, such a structured approach facilitates QC reporting (H) and will as previously demonstrated lead to a substantial improvement in MRI quality within such clinical trials.The reliable collection of metadata and effective assessment of protocol compliance in clinical trials that use MRI in broad multi-center environments has been a major challenge. Due to the inability to readily recognize variabilities which enables feedback and training / learning opportunities, consistent image quality was only insufficiently achievable and led to a substantial underutilization of MRI within Phase 2 and Phase 3 therapeutic clinical trials. The developed quality assurance methodology facilitates a semi-automated, highly structured approach adapted to the complexity of clinical care based MRI within multi-center trials. While the commonly used phantom based performance assessment characterizes the ability of the MRI system to meet industry or expected clinical trial system standards, the most extensive and quality impacting variability occurs in the extensive variability of MRI acquisition, post-processing parameter which are commonly not readily mapped. The developed heat mapping of QC assessment parameter enable an effective and efficient visual assessment of overall and/or specific performance characteristics.Innovative quality assurance methodologies such as developed and presented for the performance of MRI within therapeutic multicenter clinical trials are essential and will help overcome the hesitation and reluctance to more readily use MRI within Phase 2 and Phase 3 trials while ensuring the desired quality of the imaging readouts.