IThis grant application targets the development of electronic support tools and standardized terminology to enhance the safety and efficiency of human subjects research. This proposal will build on and integrate several current projects at the Mayo Clinic involving the electronic support of our IRB and GCRC. The Mayo Clinic IRB database system developed with the assistance of the initial HSREP grant will be expanded and linked to protocols conducted in the Mayo Clinic GCRC as well as protocols conducted jointly with two other institutions, Olmsted Medical Center and the Luther Midelfort Clinic. A major focus of this grant will be directed to enhancing the safety and efficacy of protocols conducted with the Mayo Clinic GCRC. This is an important focus because many higher risk protocols are conducted in the GCRC. Two current systems utilized in the GCRC will be expanded to promote further safety. The first is the GCRC Protocol Tracker, which is used to analyze protocols and encode them into workflow systems. This program will be expanded to include various safety checks to ensure subject safety and more standardized terminology to reduce errors. The second program is the GCRC Scheduler, which is a resource scheduling system that manages various resources such as laboratory, nursing, and dietetic functions. Computerized entry systems for laboratory test orders and decision support tools to optimize resource use, have direct potential to improve subject safety. A third application utilized in clinical practice is the Pharmacy Care (P-Care) system, which monitors all medication orders at Mayo's two hospitals. The plan is to adopt this knowledge-based system into the GCRC Tracker and Scheduler applications. These computer-supported systems will initially utilize the terminology currently employed at our medical centers. However in the second phase of the project our plan is to convert to standardized terminology such as the LOINC terms for laboratory tests, HL7-SNOMED terms for nursing procedures and disease processes, a consolidated GCRC terminology for physiology procedures and either First Data Bank or HL7 terminology for pharmacy. We plan to collaborate with the GCRC at The Scripps Research Institute in the standardization of terminology. We also will work with both Olmsted Medical Center and Luther Midelfort in evaluation of standardized procedures. We plan to share our best practices with all three of these institutions at the conclusion of the grant.
