Stanford Center for Clinical & Translational Education and Research (Spectrum)

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Project Summary The mission of Spectrum, Stanford’s CTSA-supported research Hub, is to transform clinical and translational research and education at Stanford and across the Hub network to make it more effective at discovering and implementing data-driven strategies to serve the health needs of individuals and the population and to disseminate that knowledge to trainees and the public. Many Spectrum activities, such as our Pilot Programs and KL2 Scholar Projects, require NCATS prior approval before grant funds can be spent on research. While essential for ensuring compliance with federal policies and appropriate protections for human subjects research, the prior approval process is also lengthy and plagued by inefficiencies. Another barrier to operational efficiency is the lack of a dedicated staff member to oversee other Spectrum-related submissions to the eRA Human Subjects System, obtain institutional approval for documents that are submitted to NCATS, and manage communications with NCATS. Inefficiencies in Spectrum-related administrative interactions with NCATS delay study start up and hamper progress towards our overall goal of transforming clinical and translational research. With this Administrative Supplement, our overall goal is to facilitate consistency, efficiency and enhance the submission of successful CTSA-related information packages to NCATS. Reporting to the CTSA Executive Director, a QC/QA project manager will lead improvement initiatives within Spectrum to enhance the quality of our submissions to NCATS and the eRA Human Subjects System and streamline communications within Spectrum and between Spectrum and NCATS. Our Specific Aims are to: (1) Hire and onboard a full-time quality assurance/quality control (QA/QC) project manager, (2) Develop and implement processes to improve the quality of CTSA-related document submissions to NCATS and the eRA Human Subjects System, promote proactive and timely communications, and enhance engagement and coordination with departments and their CTSA faculty and staff to review and obtain institutional approvals for submitted documents. This includes performing quality reviews and management of all CTSA-related submissions to NCATS, and (3) Use a data-driven approach to evaluate the effectiveness of new processes and use the data to implement continuous and timely improvement. Successful completion of these aims will substantially improve Spectrum’s communication and coordination with NCATS, enable faster research progress, and ultimately help advance our overall mission.