When a patient in a clinical study experiences a Serious Adverse Event (SAE), there is nothing more frustrating for the site than to be asked to resupply information that is already in the EDC system. Providing the event details again, the patient demographics, the lab results and a potentially long list of concomitant medications, represents unnecessary and duplicative work. TrialMaster solves this problem by providing mechanisms to detect an SAE and transmit the data to the clinical safety team in the industry-standard E2B format, obviating the need for site personnel to reenter the data. This digital transmission covers the event(s) in the safety case, plus all related information, and the case may be versioned over time as the source data changes.
The SAE information is automatically selected based on a mapping from the source data that is specified during study design. No programming is required. Furthermore, this means that future study designs may reuse the same mapping, which significantly reduces the setup time. This mapping reuse does a “best fit” analysis between the source study and the target study. For example, if the original study collected AE start time but the new study doesn’t, the mapping to the E2B start time element is nulled out in the new study. The designer may either leave this null value in place, or inspect a “variables not mapped” report and remap the variable to a different item in the study.