Sophisticated trial management features include dynamic visit schedule allocation based upon subject status (i.e. Screening, Enrolled, Cohort assignment, etc.). It’s easy to add unplanned iCRFs and Visits by site users. There’s support for radio buttons, check boxes, dropdown lists and calendar controls to minimize data entry time and the Date and Time fields support the use of “Today” and “Now” buttons for data entry efficiency.
TrialMaster supports data calculations to be performed immediately while data is being entered into the fields required for calculation even before the data is saved. This immediate feedback helps to prevent data entry and transcription errors prior to saving. And TrialMaster automatically triggers dual data validation at the time of entry and at the time of posting to the server.
Regardless of whether edit checks involve a single field, multiple fields, multiple forms or visits, validation messages can be triggered and alerted to the user immediately upon its detection. There’s no need to save the form first or to run any batch job to detect even the most complex validation checks.
The built-in messaging and notification subsystem easily triggers internal and external (via any email address) notifications of over 30 key study-related activities such as Enrollment of a Subject, Subject is Dropped, Completion of an AE form, Opening or Response to a Query or Data Export Available.
The data review and signatures feature in TrialMaster includes an out of the box task list for iCRFs awaiting signatures. The system supports a signature password that is different than the login password and signatures are supported at different levels (single form or group of forms). Permissions for signing iCRFs can be set at the CRF category level. Examples of common configurations include: signing of any iCRFs restricted to Investigator only and signing of any iCRFs shared between Investigator and coordinator roles.
Data Monitoring & Cleaning in TrialMaster is fast and efficient. The system supports read-only access for CRAs and Monitors with the ability to monitor and query data. Using the out of the box Task list for Monitoring and Query Management, Data Managers and CRAs can open, respond to and close a query.
The system provides the ability to easily perform monitoring (source document verification) at the field, page, visit, patient, site and the study level. Monitors can lock and unlock data from the page level up to the study level and perform monitoring activities across multiple studies and sites through a single sign-on. |
