The proposed Methodology Core (MC) builds on the experience and expertise gained from the previous 13 years ofoperation 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, studyconduction, data analysis, and reporting for projects within the MCRC program, as well as projects in the research baseand to the broader pediatric rheumatology community.The MC is staffed by personnel experienced in the broad areas of hypothesis formulation, protocol and case reportform development, data management and retrieval, quality assurance and analysis, regulatory affairs, and reporting ofresults. The MC is also experienced in evaluating data safety and monitoring issues, and in the Investigational NewDrug (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 rheumatologyin general through a variety of teaching mechanisms.Mechanisms include classroom instructional sessions that are part of course offerings through CCHMC and theUniversity of Cincinnati College of Medicine, journal clubs, lecture series, and supervised literature reviews designed forjunior faculty, fellows, and residents, as well as one-on-one instruction by investigators, and educational articles andbook chapters.3. To serve as a catalyst for promoting inter-disciplinary research both within the research base and in the pediatricrheumatology community in general.A chief focus of the MCRC is the promotion of research that crosses disciplines and synergizes resources to increaseoutput, both in terms of knowledge gained and reported, and in grant support obtained. The MC is in a unique positionto leverage resources and expertise in the research base when preparing proposals and developing methodologiesthrough interactions with investigators in different divisions and through interactions with the NIH supported CincinnatiCore Center P30. In addition, it is not uncommon for an investigator to ask the MC to perform tasks that require skillsnot present in the MC itself. In such cases, the MC facilitates the performance of such tasks by bringing togetherindividuals having such skills with the investigator who requires the specialized skills, thereby promoting interactionamong investigators.To make the expertise developed in the MC and the Center better and more rapidly available to the research baseand the pediatric rheumatology community, the MC is overseeing the enhancement and maintenance of the MCRCWebsite.Long -Term Goals. The longer-term goals of the MC are to increase the overall quality and quantity of translationaland clinical science, and to promote interdisciplinary research within the research base and in the very large pediatricrheumatology community in existence at CCHMC.
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