CTSA Program Projects & Initiatives

Last Updated: Wednesday, March 4, 2020 - 03:57 pm EST

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

Last Updated: Wednesday, March 4, 2020 - 03:57 pm EST

The National Center for Data to Health (CD2H). Through the CD2H, informatics experts are developing standardized approaches and best practices, including algorithms and other specialized tools, to address operational and institutional barriers to sharing data. Learn more

Last Updated: Wednesday, March 4, 2020 - 03:57 pm EST

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

Last Updated: Wednesday, March 4, 2020 - 03:58 pm EST

The Regulatory Guidance for Academic Research of Drugs and Devices (ReGARDD) affiliates are comprised of regulatory affairs specialists and experts from North and South Carolina Institutions 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. Learn more

Last Updated: Wednesday, March 4, 2020 - 03:58 pm EST

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

Last Updated: Wednesday, March 4, 2020 - 10:05 am EST

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

Last Updated: Wednesday, March 4, 2020 - 03:59 pm EST

The Trial Innovation Network is a collaborative national network that focuses on operational innovation, excellence and collaboration and will leverage the expertise and resources of the CTSA Program. Learn more