An EDC system is only successful if the investigative sites find it easy and convenient to enter the required data. All EDC systems claim to be user-friendly, but most offer only a pedestrian interface that can be cumbersome and awkward to use. Consider a standard example where an adverse events form needs to collect the start date and either an “ongoing” flag or an end date. The diagram below compares the old-fashioned approach with the TrialMaster approach:

The Old way Vs. The TrialMaster Way

Intuitive Electronic Data Capture

The old-fashioned way requires that all three fields be left enabled (enterable), which allows two ways for the user to enter inconsistent data. The result in each case is a time-consuming query. By contrast TrialMaster guides the user, by disabling the stop date field if the “Ongoing” field is checked, or enabling the stop date field if the “Ongoing” field is unchecked. TrialMaster is uniquely able to provide this capability because edit checks are written in JavaScript and execute in real-time, using AJAX processing.

In the example above, the stop date field is enabled or disabled instantly as the user toggles the “Ongoing” checkbox on and off. It is impossible to enter inconsistent data. This architectural breakthrough provides a level of responsiveness that is impossible with older EDC systems, where the edit checks don’t execute until the user presses a Submit button. This unique mechanism for guided data entry is supplemented by other features that provide tremendous ease of use for site users[LT1] :

  • Date fields may be entered by selecting a calendar control, or by using a single-click icon for “today”
  • Partial dates are handled by entering a value such as “//1980” for a date sometime in 1980 – this requires half the keystrokes compared to many competitive systems
  • Coded fields are entered using checkboxes, radio buttons or drop lists
  • Missing codes such as “NA” may be entered into numeric fields without triggering a query
  • Derived fields are populated in real-time, providing immediate feedback on the accuracy of the entered data
  • Queries may be handled immediately by entering a “bypass note” that explains the validation failure
  • Supporting data such as scanned images can be attached to any form, providing unified documentation such as a patient’s informed consent signature
  • A partially-filled form can be saved as incomplete without triggering extraneous edit checks and without having to enter unnecessary change reasons when the form completed.

Convenient Navigation

The user can easily locate data using a convenient navigation tree. Any number of visits may be expanded at one time, giving a convenient visualization of the data for one or more patients. Each form includes a status icon which indicates whether it is complete or incomplete, has a query, is monitored, etc. An alternate navigation method is to find data from the task list, such as this example to show open queries:

The iCRF column contains a hyperlink, which leads the user directly to the corresponding form. The second row shows that queries may be placed at any level in the trial (such as to the site in this case). This is more convenient than adding query to an arbitrary patient CRF.

Data Management and Reporting

TrialMaster has sophisticated query management facilities, with user-defined workflow to control how queries are routed between different roles and/or users. Similarly, TrialMaster can handle all standard operations on completed forms, namely review, monitor, sign and lock. These operations may be executed at the form, visit or patient levels. There are many standard reports to aid these processes, including a query aging report, various page status reports, and a report to flag missed and late patient visits. For data-dependent reports such adverse event listings, TrialMaster provides a seamless interface to the LogiXML® reporting package, where sophisticated reports and graphics may be generated by following a simple wizard interface. An example an Adverse Events report is shown below:

Imports and Exports

TrialMaster can import data from a variety of sources, such as labs or patient diaries, using an automated file import utility. The supported formats include HL7 lab format, delimited ASCII and XML. An alternative mechanism is to use OmniConnect, a CDISC-compatible set of APIs that can be called by any authorized remote application using web services. It is common to use the APIs when real-time verification of results is required, such as when enrolling a patient via an IVRS. Data exports may similarly be requested in standard formats, such as CSV files or SAS datasets. TrialMaster provides a default set of exports based on the forms and item groups in the study, but these can be supplemented with user-defined datasets. These datasets can include joins across different forms, computed columns using SQL formulae, and screening criteria to restrict certain rows of data; it is even possible to generate the vast majority of SDTM datasets –including the define.xml file – without programming. This breakthrough technology allows the user to map input fields to output domains and variables, using a highly-productive drag-and-drop interface. TrialMaster doesn’t just save your sites time, it saves your programmers time.

Integrations

TrialMaster has a number of standard integrations that provide sophisticated additional capabilities:

  • Autoencoding – Allows automated and manual coding of terms against MedDRA and WHODrug
  • SafetyLink – Provides automatic feeds of SAEs and related data to a full safety system using the industry-standard E2B format
  • IVRS – Provides integrations to two leading IVRS products

As described above, new integrations can easily be developed using the OmniConnect APIs.

The complete package

With the most intuitive end-user experience, the most productive study design tool, flexible reporting, off-the-shelf integrations and convenient mechanisms for importing and exporting data, TrialMaster offers a compelling solution for electronic data capture.