An Interactive Clinical Monitoring System

Abstract

A fourth-generation relational data-base system is employed at the Pharmaceuticals Division of Ciba-Geigy Corporation to process data generated by clinical trials. The basis for this system is the data-base management system, Oracle, which is run on a dedicated computer, an IBM 4361, under the VM/CMS operating system. This system replaced a batch data-base system based on IBM's IMS data-base management system. The Oracle system is fully interactive, allowing on-line entry and access to the data stored in relational tables. Data entry is accomplished through Oracle's Interactive Application Facility which displays case report form images on CRT screens. The data is edited as it is entered with checks on data validity, consistency, and numeric ranges. The data from different visits can be directly compared for consistency checks. The data are also screened for protocol violations by routines which act on the fields associated with patient inclusion and exclusion characteristics. Data can be retrieved either in the case report format or through Structured Query Language (SQL), an English-like retrieval and reporting language which acts on relational tables. Views of relational tables can be created so that the data base can be logically structured to suit the needs of the users. An integrated data dictionary based on relational tables gives complete information about the data-base structure which can also be queried through SQL. The data-base tables or views can be directly converted to SAS data sets for statistical analysis. The perceived advantages of the Interactive Monitoring System include the ability of end-users to directly access the clinical data and perform queries and retrievals to continuously monitor ongoing studies. The interactive data entry system screens for inaccuracies before the data are committed to the system thereby reducing the need for extensive data clean-up procedures. The Oracle system also reduces the lead time needed for programming each clinical study, since program development and testing are done in an interactive mode.