Three-Layer Model for the design of a Protocol Support System

Results and conclusions: To support the representation of a study protocol integrated in routine clinical care, a Three-Layer Model was developed. This model distinguishes the protocol description, local adaptations to the protocol and communication as three separate layers. These layers have been incorporated into the knowledge acquisition tool Gaston. The Three-Layer Model makes easy updating possible, and also supports transferability of computerized (study) protocols to other organizations.