CTSA Program Projects & Initiatives
The Accrual to Clinical Trials (ACT) Network is a real-time platform allowing researchers to explore and validate feasibility for clinical studies across the NCATS Clinical and Translational Science Award (CTSA) consortium, from their desktops. ACT helps researchers design and complete clinical studies, and is secure, HIPAA-compliant and IRB-approved. Learn more
The National Center for Data to Health (CD2H). The CD2H provides support and infrastructure, ensuring a smooth and successful transition for CTSAs. Our tools and resources make it simple and valuable for CTSA Program members to get engaged, connect with peers, and contribute. By increasing collaboration, the CD2H fosters a robust translational science informatics ecosystem that will collectively develop solutions to solve clinical problems faster, more efficiently, and more effectively.. Learn more
IRB Reliance Exchange (IREx) is a freely available, web-based portal supporting single IRB review documentation and coordination for multi-center clinical trials. Learn more
The Regulatory Guidance for Academic Research of Drugs and Devices (ReGARDD) affiliates are comprised of regulatory affairs specialists and experts from several Institutions in the Southeast that receive funding from the NIH Clinical and Translational Science Awards (CTSA) Program. ReGARDD provides academic researchers with the regulatory tools and resources necessary to successfully navigate the pathway from discovery to clinical implementation of new drugs, biologics and medical devices.
SMART IRB (the Streamlined, Multisite, Accelerated Resources for Trials IRB Reliance platform) is designed to harmonize and streamline the IRB review process for multisite studies, while ensuring a high level of protection for research participants. SMART IRB is not an IRB; rather, it's a platform that offers a master IRB reliance agreement (the SMART IRB Agreement) and a web-based system (SMART IRB's Online Reliance System) that provides a central process for participating institutions and their investigators to request, track, and document study-specific reliance arrangements. Learn more
TEAMSS (Transforming Expanded Access to Maximize Support and Study) seeks to advance clinical care and translational research by improving patient access to experimental therapies. This federated, national consortium for Expanded Access interventions is a partnership led by the University of Michigan with Duke University, University of Rochester and University of Texas Southwestern