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TrialMaster 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.
Click here to learn about what sets TrialMaster apart from other systems. Click here to read a product brochure.
The old-fashioned way requires that all three fields be left 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 therefore 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 a host of other features that provide tremendous ease of use. 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 is half the keystrokes compared to many competitive systems; coded fields are entered using checkboxes, radio buttons or droplists; missing codes such as “NA” may be entered into numeric fields without triggering a query; derived fields are populated in real-time, giving comforting feedback on the accuracy of the entered data; queries may be handled immediately by entering a “bypass note” that explains the validation failure; and supporting data such as scanned images can be attached to any form, providing unified documentation such as a patient’s informed consent signature; Finally, the user can save a partially-filled form as incomplete without triggering a flood of edit checks and without having to fill in a raft of change reasons when the form is subsequently completed. TrialMaster has been designed to make the life of the site user as easy as possible. Convenient Navigation
The iCRF column is a hyperlink, which jumps the user straight 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 natural than affixing such a 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 may all 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 AE 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:
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. Sign up for a demo today by contacting info@omnicomm.com. |
