The Arthritis Foundation OA Virtual Center of Excellence Clinical Trial Network Site Charter Agreement - PTOA Platform

This purpose of this project is to develop a clinical trial network platform to launch a Posttraumatic Osteoarthritis (PTOA) Master Protocol research program. We will, as part of this project, establishment of a dedicated research team, develop tools for data management and research oversight, develop and finalize a Clinical Trial Network PTOA Platform Master Protocol design, prepare a Clinical Trial Network PTOA Platform operations/procedures manual, acquire dedicated equipment required for PTOA Platform Master Protocol, and participate in dedicated team travel for annual meeting & training. This will be done to permit early peer review of the rationale and concept for the proposed Clinical Trial Network PTOA Platform, support development of essential elements of a Clinical Trial Network PTOA Platform, and lead to approved protocol support of a full-scale PTOA Platform Master Protocol clinical trial, based on elements developed under this charter site platform launch period. We will participate in monthly conference calls convened by the Foundation, provide monthly documented updates, attend annual face-to-face meeting which will evolve into an annual Foundation Clinical Trial Conference and require participation as faculty presenters, create a report of annual volume of ACL injured patients with the level of detail outlined in the Clinical Trial Site qualifications (number of total ACL patients, number that meet MOON inclusion criteria, time between injury and presentation, time between presentation and surgery, number of patients that live in close proximity to site, etc.), complete a demonstration project of a completed CFR21-compliant electronic data capture project to show feasibility for FDA regulated studies, complete a summary statistics of t1rho analysis of previously collected MRI scans, and a quality improvement project to streamline the process for patients to have preoperative t1rho sequences collected within 24 hours of enrollment.