Patent ID: 8683435

Claim:
A designer program capable of providing tools for configuring a clinical trial program to execute a protocol of a clinical trial, the clinical trial program comprising a data capture and data management system capable of collecting data from geographically disparate users, the designer program comprising computer executable instructions encoded on a non-transitory computer readable medium that, when executed on at least one computer system perform a method comprising: receiving, through a user interface, user input representing a plurality of components of a clinical trial, the plurality of components comprising: at least one event representing a patient visit; at least one path representing a sequence of patient visits; a plurality of data items; at least one form; and at least one domain, each domain defining a relationship between at least some of the plurality of data items wherein the relationship defined in each domain reflects a logical grouping of the at least some of the data items for reporting and/or exporting the at least some of the data items, wherein the logical grouping is distinct from the protocol of the clinical trial, wherein the user interface comprises: a stencil window comprising a plurality of shapes, each shape representing at least one of the plurality of components of the clinical trial and each shape including customizable properties, the plurality of shapes including a Domain shape representing the at least one domain; and one or more design windows capable of accepting ones of the plurality of shapes selected by a designer from the stencil window, wherein selection of the ones of the plurality of shapes and subsequent editing of their customizable properties allow a designer to model a protocol of a clinical trial; dynamically generating or modifying, based on the user input, at least one configuration file for the clinical trial program, wherein the at least one configuration file includes one or more instructions for configuring the clinical trial program to execute the protocol of the clinical trial; and generating a report or data export, wherein the report or data export is generated based, at least in part, on the at least one domain as specified in the at least one configuration file.