Abstract: The present invention includes aspects of a designer program or tool for customizing a clinical trial program to a particular protocol of a particular clinical trial. The designer program includes visual cues or mechanisms for organizing trial components within the designer program in a straightforward manner such that technically low skilled designers can implement often complex trial protocols. In an embodiment, the designer program includes validation scripts that test functions, derivations, queries and the like. Moreover, use of the designer program can include development of trial libraries that can make customizations reusable, scalable, and highly efficient.