Integrated Forms Technology for Clinical Trials

Our goal is to develop a new data collection technology for clinical trials that can reduce the effort needed to gather clinical research data and improve the timeliness and quality of the data. The technology is based on an integrated approach that uses the familiar case report form model to support more direct and efficient communication between clinical personnel (e. g., investigators, medical monitors, clinical data coordinators) and the clinical data system. Phase I research will be focused on (l) concept refinement through interaction with collaborators at academic and biotechnology industry clinical research organizations, (2) design of a new integrated software tool for clinical data definition and collection, and (3) construction and evaluation of an initial prototype. The major technical innovation is to utilize advances in computer-assisted software engineering, graphical layout, laser printing, facsimile transmission, and machine-readable identification to automate aspects of case report form management that now require many separate manual steps. The major health-related benefit is to improve the speed and accuracy of clinical trial data collection, and therefore to contribute to improving the efficacy of clinical research in evaluating new treatments for cancer, AIDS, and other diseases.