Clinical case report forms design--a key to clinical trial success.

Abstract

Clinical case report forms--from both a content and format point of view--play a key role in the successful completion of a clinical trial. However, as many of us are too well aware, the design of these forms are often given less attention than they should be in the rush to get a clinical trial underway. This session will highlight the importance of well-designed case report forms and offer some suggestions on how to improve the effectiveness of these forms. The obvious and not so obvious benefits in the use of "standardized" forms will be presented and some sample "standardized" forms presently in use by Merck Sharp & Dohme Research Laboratories will be discussed. Since both the cost and timing of the formal composition and printing of these case report forms are always key management concerns, a time and cost effective solution to these concerns will be presented.