Methodology Core

Cincinnati Childrens Hosp Med Ctr, Cincinnati OH

Investigators

Linked publications & trials

Abstract

The proposed Methodology Core (MC) builds on the experience and expertise gained from the previous 13 years of operation during prior P60 awards. Three specific aims are proposed. 1. To serve as a multifunctional MC resource that provides in-depth assistance during protocol design, study conduction, data analysis, and reporting for projects within the MCRC program, as well as projects in the research base and to the broader pediatric rheumatology community. The MC is staffed by personnel experienced in the broad areas of hypothesis formulation, protocol and case report form development, data management and retrieval, quality assurance and analysis, regulatory affairs, and reporting of results. The MC is also experienced in evaluating data safety and monitoring issues, and in the Investigational New Drug (IND) application process for clinical protocols. A new addition is an information technology specialist. 2. To increase the clinical research competence of investigators within the research base and pediatric rheumatology in general through a variety of teaching mechanisms. Mechanisms include classroom instructional sessions that are part of course offerings through CCHMC and the University of Cincinnati College of Medicine, journal clubs, lecture series, and supervised literature reviews designed for junior faculty, fellows, and residents, as well as one-on-one instruction by investigators, and educational articles and book chapters. 3. To serve as a catalyst for promoting inter-disciplinary research both within the research base and in the pediatric rheumatology community in general. A chief focus of the MCRC is the promotion of research that crosses disciplines and synergizes resources to increase output, both in terms of knowledge gained and reported, and in grant support obtained. The MC is in a unique position to leverage resources and expertise in the research base when preparing proposals and developing methodologies through interactions with investigators in different divisions and through interactions with the NIH supported Cincinnati Core Center P30. In addition, it is not uncommon for an investigator to ask the MC to perform tasks that require skills not present in the MC itself. In such cases, the MC facilitates the performance of such tasks by bringing together individuals having such skills with the investigator who requires the specialized skills, thereby promoting interaction among investigators. To make the expertise developed in the MC and the Center better and more rapidly available to the research base and the pediatric rheumatology community, the MC is overseeing the enhancement and maintenance of the MCRC Website. Long -Term Goals. The longer-term goals of the MC are to increase the overall quality and quantity of translational and clinical science, and to promote interdisciplinary research within the research base and in the very large pediatric rheumatology community in existence at CCHMC.