Development of an Open Source Research Management System

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DESCRIPTION (provided by applicant): The pharmaceutical industry has access to well-designed clinical trial management software (CTMS) for their studies. Specialized CTMS packages are essential for drug trials but are not optimal for other kinds of clinical research, such as observational, epidemiological, and mechanistic studies, nonpharmacological intervention trials, health behavior research, etc. Researchers who work in these areas need software that is flexible enough to accommodate an unlimited variety of clinical research protocols. Because no suitable software packages were available for this type of clinical research operation, we developed a web-based clinical research management system for our own studies. It quickly became an indispensable tool for our clinical research laboratory. We are currently using it to manage two large, NIH-funded clinical studies, as well as smaller projects. Many other clinical researchers need similar software. However, the present system was designed specifically for the developers' own laboratory, not for dissemination. The purpose of this Phase I STTR application is to redesign this software to prepare it for dissemination as a scalable, open source application, and to perform systematic alpha and unit testing to confirm its technical feasibility. The system has numerous features that will make it especially useful for academic clinical research laboratories. These include web-based and integrated remote data collection via dual-use (electronic data capture [EDC] and paper) forms; analysis and reporting utilities to support operational study management; study document and media management capabilities; and tools to facilitate sharing of analytical programs, data, and analytical outputs among researchers in an organized and permissions-based manner. The system's EDC facility enables research teams create complex, intelligent, dual-use forms containing data integrity constraints, skip logic, and scoring algorithms, and applies this information both to the forms and to the research database. It includes numerous data integrity, data security, and HIPAA compliance features, and supports online data collection, as well as offline data collection through a separate, integrated, client-side application. For reporting and analysis functions, the application is bundled with a powerful, open source statistical application, and it also provides seamless connectivity to SAS. The application is database-agnostic and fully scalable. This will enable it to serve the needs of small research labs utilizing a single, self-contained installation, as well as larger laboratories and multicenter collaborations that may utilize multiple application servers through a distributed, web services-based architecture. The application facilitates EDC, reporting, and operational management for labs with limited technical resources, while exposing the full power of underlying software tools for labs with access to technical staff. The small business concern will provide training, customization, and support services for users. PUBLIC HEALTH RELEVANCE: This is a proposal to prepare a clinical research management software package for dissemination. Unlike other software packages that are designed exclusively for pharmaceutical trials, this system is designed to support a wide variety of clinical research protocols. It is expected to improve the productivity and cost-efficiency of clinical research operations, and to help research teams meet high standards for data integrity, data security, and HIPAA compliance.