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    TrialMaster™ TrialDesign

Designing and Building EDC Trials With TrialMaster



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

  • Create a new trial, or import the definitions from a prior trial or global library
  • Build the code lists, items, item groups and forms to implement the eCRFs in the trial
  • Build one or more visit schedules, and map the forms to their appropriate visits
  • Develop the edit checks, derivations and dynamic form behaviors
  • Generate default data export definitions (by form and/or by item group)
  • (Optional) Define custom data exports, including Study Data Tabulation Method (SDTM) domains
  • (Optional) Define the format of files to be imported
  • (Optional) Define lab tests with units and conversion formulae
  • (Optional) Set up mappings of data elements to MedDRA and WHODrug for coding
  • (Optional) Set up randomization scheme
  • Deploy the trial to a UAT environment for testing
  • Deploy the trial to a production environment

Modeling the eCRFs

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.

eCRF Layouts

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.

Edit Checks

Edit checks encompass range checks on a single item, comparisons between items on the same or different forms, and complex logic such as randomization algorithms. Edit checks are written in JavaScript, which is the standard programming language for adding interactive behavior to an HTML web page. For most cases, the JavaScript programming is minimal. For example, to check that an AE start date is before the stop date, drag the start date item into the expression window, type “<=”, then drag the stop date item into the window. This asserts that the data is valid if the start date is less than or equal to the stop date. Edit checks may be defined at any level of the hierarchy. The example above is defined with the “DM01” group because the logic is the same regardless of where the group is used. However, if the check is sensitive to the visit information, such as checking that that visit occurred within an allowed time window, then the edit check would be defined within the appropriate visit.

Other available edit actions are:

 

Item / Group Properties Derivations Object Creation
Set hidden/displayed Set item value Create visit
Set enabled/disabled Set item row value (prefill) Set form caption
Set enterable/read only Set form caption Include form in add list
Set required/optional
Enforce unique value



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Contact Us      North America +1 877.468.6332      Europe +49 (0) 228 227 440      Click Here to Email Us

Contact Us
North America
+1 877.468.6332
Europe
+49 (0) 228 227 440
Click Here to Email Us