TrialMaster not only makes it easy to get the data into the system, it also makes it easy to get the data out. Below is a sample AE listing that embodies some deceptively sophisticated logic:
The listing joins the Adverse Events to the Demographics to include the patient’s age and sex, then compares the onset date to the patient’s first dosing date to determine if the AE was treatment emergent. The final column lists all the concomitant medications the patient was on at the time of onset. This logic is built as part of the study design and is made available at the user’s fingertips, for the whole trial, for a site, or for individual patients.
This same extended design capability allows the production of custom SAS datasets, which can include both the clinical data and operational data (such as query response times). The clinical data can also be mapped against any of the SDTM standards to produce submission-ready datasets. These facilities include the population of derived variables, such as “study day,” unit-of-measure conversion, pivoting of data to create questionnaire and lab domains, and the creation of supplemental datasets.
TrialMaster also supports the development of graphical dashboards using the adhoc query tool LogiXML. These dashboards can be assigned to specific user roles, so different types of users see different information. The assigned dashboards are then displayed on the homepage when the user logs on.