For Investigators Office of Research Research Administration Clinical Research Support Office (CRSO) For Investigators REQUEST CCTS / CRSO SERVICES The University of Kentucky's Center for Clinical and Translational Science (CCTS) and the UK Clinical Research Support Office (CRSO) has transitioned to a membership model. This shift will allow us to more effectively manage the needs and services requested by those engaged in research. Request Services For Investigators Which investigators should contact the CRSO about their projects? Any investigator who is leading, or planning to lead, a trial that meets the NIH definition of a clinical trial (https://grants.nih.gov/ct-decision/index.htm) should contact the CRSO. The CRSO provides services institution-wide, so we welcome investigators from all colleges. What types of trials does the CRSO assist with? The CRSO works with investigators on any trial meeting the NIH definition of a clinical trial (https://grants.nih.gov/ct-decision/index.htm). Our office will help investigators with initial coverage analyses and amendments and entry of the trial into our clinical trial management software (e.g., study visit calendar). Depending on the study team needs, we can also help with regulatory, recruitment and financial aspects of the trial on a fee-for-service basis. When should investigators contact the CRSO? We encourage investigators to contact the CRSO about their trial as soon as possible, even before IRB approval is granted and contracts are signed with sponsors. This enables our team to start building the trial into the clinical trial management software and begin the coverage analysis in a way that expedites the process and ensures study teams can meet their projected timelines. Are there fees for CRSO services? Effective Aug. 1, 2020, the Clinical Research Support Office will begin charging fees for coverage analysis for new qualifying pharmaceutical industry-sponsored clinical trials. The office will not charge fees on studies that have already started or are in the process of starting before Aug. 1 The CRSO will charge $3,200 for new qualifying industry sponsored studies and $1,000 for any significant sponsor-driven amendments that alter the study visits, procedures or calendar. The office will send an invoice directly to sponsors, but study teams must include it in their study budgets. How do investigators contact the CRSO? Services may be requested through the CCTS/CRSO service request form (https://cctsdata.uky.edu/membership/). If you have other questions, you can contact the CRSO Director, Dr. William W. Stoops, at email@example.com. Clinical Research Support Office Facilities Description The Clinical Research Support Office (CRSO) was created in 2018 as a partnership between the University of Kentucky (UK) College of Medicine, UK Health Care, the Office of the UK Vice President for Research and the UK Center for Clinical and translational science. The goal for establishing the CRSO was to reduce administrative burdens of conducting clinical trials, enhance efficiency, provide tools to study teams that allow for enterprise wide automation and gathering of important metrics (e.g., clinical trial accruals) and increase compliance with federal and state guidelines. As such, the CRSO is dedicated to providing services to assist in utilization of the clinical trial management system, OnCore, and providing financial management support. Our staff of thirteen, under the direction of Dr. William W. Stoops, build clinical trial protocols into OnCore for study teams to track subject accrual and project timelines, produce the insurance coverage analysis, provide IT support, software training, budget development, negotiation and post award management. The CRSO also oversees the maintenance of the University instance of OnCore and the integrations with our other institutional software.