The POSCH Information Management System: experience with alternative approaches.

An unconventional approach to the information management system for a clinical trial is presented in this paper: employment of a large shared computer utility, use of existing packaged software, and use of a generalized data base management system. An easily maintained system was developed at a very economical cost. The paper is designed to present our experiences and include descriptions of a series of problems that were faced and solved: design problems, problems with error corrections, and problems unique to our operational procedures. The good results are due as much to careful management as to the initial decision to use the unconventional approach. Special attention has been paid to cost controls, patient safety, and data security. The approach has been successful, and others are encouraged to consider a similar approach.