An adaptable assessment generation system for clinical trials complementing human research information system

Computerized testing methods have long been used for presenting clinical questionnaires and are regarded as an efficient and accurate data collection mechanism in human research settings. In order to adapt to the constant addition of new research protocols and incorporate the new data collection forms and questionnaires into our computerized medical information environment, it is necessary to have a solution that requires no modifications to the source code for creating new questionnaires and renders the results in a Web browser-based format that can be seamlessly integrated into our patient records system. In this paper we describe our test and questionnaire system (TQS) that addresses our requirements and provides full-page browser-based assessments. In addition to managing the new questionnaires, TQS seamlessly communicates and incorporates the clinician-generated assessments built on and for a handheld electronic diary system and provides a powerful and user-friendly data extraction mechanism that allows full or selective data export for further analysis. This solution not only employs both a generic building tool and a flexible data model, but also renders the required questionnaires in a Web browser-based environment making it possible for the collected data to become an integral part of our browser-based human research information system. Since its implementation 4 years ago, this system has been used to generate approximately 300 questionnaires at our site and is designed to provide the necessary adaptability and flexibility required for all of the current and potentially a very high percentage of future protocols.