Clinical trials research requires specialized software tools to enter, process, and validate data. Creating these tools adds significantly to the duration and cost of most clinical trial studies. The goal of this project is to develop a comprehensive software development product that will simplify, accelerate, and reduce the costs of creating customized, high-quality clinical trial data management systems. The proposed product will provide efficient, user-friendly access to all of the basic and specialized functions needed in this domain. It will be applicable to a wide variety of study designs and environments. It will allow users to choose different combinations of functions for different contexts. It will be extendible though standardized interfaces, allowing special-purpose modules to be added with minimal programming effort. it will be organized around a core data dictionary containing all the information necessary for program generation, system documentation, and communications among system modules. All modules will be formally validated to ensure stringent standards of accuracy. The aims of this grant are to design the architecture of the system; to develop specifications for major components; to build prototypes of these components; and to use the prototypes to demonstrate the feasibility and merits of the system.Proposed commercial application:The software to be developed under this grant will permit pharmaceutical companies, NIH grant recipients, universities, and others engaged in medical research to quickly and inexpensively create professional-quality computer systems for managing their medical research data, even when the users have minimal data management training and experience. Saving for NIH grantees and pharmaceutical companies could reach millions of dollars annually. More importantly, the use of professional quality data management systems will lead to much higher quality medical data. The market for this product is similar to the market for SAS in theses research areas.National Institute fo General Medical Sciences (NIGMS)
