Clinical and translational (C/T) research is essential to bring the discoveries of biomedical science to benefit the health and well-being of our nation. The Clinical and Translational Science Collaborative (CTSC) of Cleveland is a catalyst for high quality C/T research both locally and nationally. It is a leader in disseminating best practices and promoting multi-site clinical research. The CTSC of Cleveland created a solid foundation to utilize the power of this collaborative to ensure rigorous and innovative training of the C/T workforce, to accelerate the translation of discoveries to patients, to improve the health of Cleveland, and to provide scalable models for other locations across the nation. This project will establish a single, dedicated individual to perform quality reviews of CTSA-related submissions to NCATS, submissions to the eRA Human Subjects System, and management of the overall process with an emphasis on ensuring consistency and efficiency. The QA/QC role will also provide consultation and training to investigators on essential submission elements and submission processes for CTSA-related information packages to NCATS including administrative supplements, specific funding opportunities, KL2 projects and pilot projects. To ensure the acceleration of research, the activities related to the quality assurance/quality control (QA/QC) role of the CTSC will be conducted in the Center for Clinical Investigation (CCI) adjacent to the office of the Dean for the School of Medicine and office of the Vice- Dean for Translational Research (PI of the CTSA).
The restructuring plan to centralize effort and establish a single, dedicated individual serving in a quality assurance/quality control role within the CTSC will provide benefit both to NCATS and to our own administrative operations. In addition to reviewing and managing the overall process of CTSA-related submissions to NCATs through the eRA Human Subjects System, we will also provide training to investigators and other institutional personnel on a broader scale to systematically improve the NCATS submission process. The new quality assurance role will positively impact our hub?s interactions with NCATS and further streamline translational research.
| Belur Nagaraj, Anil; Joseph, Peronne; Kovalenko, Olga et al. (2018) Evaluating class III antiarrhythmic agents as novel MYC targeting drugs in ovarian cancer. Gynecol Oncol 151:525-532 |
| Zheng, Chunlei; Xu, Rong (2018) Large-scale mining disease comorbidity relationships from post-market drug adverse events surveillance data. BMC Bioinformatics 19:500 |
