CLINICAL TRANSLATIONAL CORE

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PROJECT SUMMARY/ABSTRACT – CLINICAL TRANSLATIONAL CORE The overall objective of the Clinical Translational Core (CTC) is to provide IDDRC-supported investigators access to resources that are critically important for the effective and efficient conduct of translational research of neurodevelopmental disorders. The CTC’s services range from cell culture studies, to preclinical animal services (animal behavior, histology, microscopy, mass spectrometry and molecular methods), to extensive clinical trial support, including consultation on protocol design and biostatistical analyses, pre-review prior to submission of protocols to the institutional review board (IRB), and hands-on advice and help with carrying out investigational protocols by experienced trialists, research coordinators and administrative staff. The Core’s directors and faculty members collectively have a high level of expertise across these services, as well as FDA regulatory expertise. The CTC will continue to support the movement of ideas and findings along the entire T4 translational continuum. This reflects the Core’s and the Center’s shared commitment to enhancing the conversion of basic science discoveries into effective, commercially available disease-altering therapies; to provide scientific input towards public policy; and, ultimately, to improve outcomes for children and adults with intellectual and other developmental disabilities. The objective of the Core will be achieved through the following Aims, which are to provide: (1) infrastructure and expertise needed to support projects focused on translation of basic science advances in the understanding of intellectual and developmental disabilities (IDD); (2) mentoring to assist IDD investigators in conducting clinical research and clinical trials; and (3) educational activities and dissemination opportunities.