TrialMaster offers a rich and versatile toolset for designing and building a trial. The toolset consists of TrialBuilder for building the trial and TrialExplorer for configuring and deploying the trial. Both are desktop tools that run under Microsoft Windows®, thereby providing a highly productive and responsive environment, complete with a multi-window user interface and drag-and-drop functionality.
Overview of the Trial Design Process Using the TrialMaster EDC Solution
TrialBuilder provides an elegant navigator for the elements in the trial. Objects are displayed in a tree view with standard expand/collapse icons. The process of modeling a new trial would typically start with defining the code lists, followed by the items, the groups, the forms and the visits. Items may be reused across groups. For example, an item “Med start date” could be placed in both a concomitant medications and a prior medications group. Similarly, the same group may be reused across forms, with properties such as the maximum number of allowed rows, which are potentially different on each form. Finally, each form is associated with the visits which may occur, with the maximum number of form occurrences specified as a property.
Right-clicking on any object provides a menu of allowable operations, such as Edit, Copy, and Delete. The Edit option shows a dialog for managing the object’s properties, which may include its name, datatype, control type, code list, SAS name, SAS format and SAS label.
Groups are built by dragging the requisite items into them. Items may be re-sequenced by dragging them up and down in the group. The same mechanism is used to add groups to a form and to add forms to a visit. This user interface is more productive and intuitive than picking items from a list.
Once the forms are defined from their component groups, it is possible to review and modify the default data entry layout for that form within TrialBuilder. The layout can be modified by editing the generated HTML, such as placing fields side by side (e.g., to enter blood pressure as ___ / ___ ), or rendering pain scale background images to guide the data entry process. This custom layout will be identical in TrialBuilder, in the EDC screens, and in the blank and completed PDF casebooks.