Washington University Institute of Clinical and Translational Sciences

项目总结

PROJECT SUMMARY This application is submitted in response to NOT-TR-20-014 as a supplement to Parent Award UL1TR002345, the Washington University Institute of Clinical and Translational Sciences (WU ICTS). The NCATS prior approval process for Clinical and Translational Science Awards (CTSA) human subject research (HSR) requires study information to be entered into the NIH eRA Human Subjects System (HSS). This requirement applies to Pilot projects supported directly with CTSA grant funding or voluntary committed cost sharing and KL2 Scholar projects that involve HSR. The entry of these studies into the HSS along with NCATS-specified documentation and email notification are required before the project can begin. The overall goal of this CTSA Administrative Supplement is to add a dedicated Quality Assurance/Quality Control position to the WU ICTS Administrative Core. Their role is to coordinate and collaborate with KL2 Scholars and Pilot PIs regarding CTSA-related submissions to NCATS, submissions to the HSS, and management of this overall prior approval process. The specific aims are included below. Aim 1: QA/QC personnel will oversee and manage internal processes for human subjects research (HSR) prior approval requests to facilitate consistency and efficiency and enhance the submission of successful CTSA-related information packages to NCATS. Aim 2: QA/QC personnel will implement a comprehensive evaluation strategy to guide decision-making and ensure continuous improvement in processes.