Human Subjects Research Electronic Tracking System

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Funds are requested to complete development and implementation of IRIS, a web-based application designed to collect, maintain and manage research data for medical studies involving human research volunteers. IRIS will interface with BRAAN, our web-based system for managing IRB documentation and business that was purchased with funds previously obtained through HSREP. IRIS will manage recruitment and scheduling of research subjects, collection and archiving of research data, automated acquisition of clinical laboratory results and generation of protocol-specific case reports and interim data analysis. IRIS will receive demographic and study-design data from BRAAN and it will return aggregate information back to BRAAN for the continuing review (demographics and status of subjects). If lRB compliance review is required, IRIS will be able to provide quality management personnel with identity, status, and detailed data for all subjects. BRAAN will store partially de-identified information and summary reports about adverse events. Each Serious Adverse Event (SAE) report in BRAAN will have a linked record in IRIS that will store the detailed medical information, containing identifiers, relating to the SAE. While all IRB members will have access to the information in BRAAN, access to the detailed reports in IRIS will be restricted to the subset of IRB members who are entrusted with the responsibility of in-depth medical evaluation of adverse events. IRIS will be developed for use by other institutions. In order to assure that it will have wide applicability, we will plan, from the outset, to give consideration to design features that may require customization to meet specific needs of different sites. To gain the necessary extramural perspective, we will collaborate with West Virginia University on this project. Although it did not receive NIH funding during the previous round ofHSREP, WVU has an active and growing human subjects research program, and is strongly considering purchasing BRAAN for its IRB. WVU has a different organizational structure, a different information technology network, and different human subjects research emphasis from the University of Maryland School of Medicine.