Both TrialBuilder® and TrialExplorer® are desktop-based tools and run under Microsoft Windows®, thereby providing a highly productive and responsive environment, complete with a multi-window user interface and drag-and-drop functionality.
Trials are configured and managed by an authorized administrator using a tool called TrialExplorer. This is a Windows product that provides a convenient navigator interface for viewing and managing all the trials in the system.
Trials are created either by copying from an existing trial, or by importing a trial definition in XML format. This XML file will have been generated via an export from TrialExplorer on the same server or a different server. In this manner, trial definitions may be effortlessly moved between environments – typically from Development to QA to UAT to Production. TrialExplorer keeps track of the different versions of the trial definition over time.
A mid-study change is handled as follows. The designer creates a new version of the trial in TrialBuilder. If change is to be deployed in a different environment – e.g., moving from Development to QA – then the trial design is exported from the source environment and imported into a new version of the trial in the target environment. The administrator then launches the mid-study change dialog and selects one or more sites to be migrated from the old version to the new version.
A sophisticated difference engine detects and processes all modifications between the source and target versions. This includes adding new items to existing forms, changing item properties (such as from enterable to read-only), handling code list changes, and re-executing all changed edit checks and derivations. The mid-study change may be executed on a running system – there is no need for planned downtime. Once the mid-study change is complete, users will see the appropriate changes in TrialMaster. For example, if a new item has been added to a form, those iCRFs will be reverted to an “incomplete” status so that the site user knows to revisit those forms and enter the additional information.