TrialBuilder for Designing and Building EDC Trials Faster

TrialMaster® is a leading-edge system for Electronic Data Capture and Clinical Data Management. One of the strengths of the system is 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 Electronic Data Capture Solution

  • Create a new trial, or import the definitions from a prior trial or global library
  • Build the codelists, items, item groups and forms to implement the iCRFs 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, incl. 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 WHO Drug 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 iCRFs

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 codelists, 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 potentially different on each of the forms. Finally, each form is associated with the visits in which it 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, delete, etc.  The Edit option shows a dialog for managing the object’s properties. In the case of an item, this would include its name, datatype, control type, codelist, 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 the more pedestrian approach of picking items from a list.

iCRF Layouts

Once the Forms have been defined from their component groups, it is possible to review the default data entry layout for that form within TrialBuilder. Usually the default layout is adequate, but if necessary the layout can be modified by clicking on the HTML tab and editing the generated HTML. This technique can be used lay out fields side by side (e.g., to enter blood pressure as ___  / ___ ), or to render background images such as a pain scale 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 form or different forms, as well as 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 the vast majority of 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

Other

Set hidden/displayed

Set item value

Create visit

Give warning on save

Set enabled/disabled

Set item row value (prefill)

Create form

Send notification

Set enterable/read only

Set form caption

Include form in add list

Set form status

Set required/optional

 

 

 

Enforce unique value