• BLOG.png


The Secret Behind Fast and Simple Data Review

Rich Davies: Mar 18, 2016 9:00:00 AM

The diverse stakeholders participating in an EDC clinical trial present equally diverse requirements for data access and visualization. At one end of the scale we have site users that are interested in quick access to specific data points, presented and summarized in a consumable format. At the other end of the scale we have data managers and perhaps medical reviewers who need a more explorative way of accessing clinical data. This means there’s no ‘one size fits all’ mechanism of surfacing and visualizing data to end users. The use of ad-hoc reporting or patient profiling tools has long catered to the data manager and medical review communities’ with interfaces that target the skill sets of those users and provide custom reporting or explorative data access as required. Site users have had less luck unless the sponsor has indulged their data access needs by building out specific reports in any ad-hoc reporting environment. Without this the investigators have been left to review the data of interest by walking through the patient eCRFs reviewing the data in exactly the format it was entered. It’s no surprise that this isn’t the most efficient way to deliver data of interest. It’s also not typical to grant site access to ad-hoc reporting environments where successfully self-serving data through custom reports requires a level of technical expertise combined with an understanding of the way the data is being captured and structured. Hence there’s a clear need for a fast and simple data review interface for site users, although the applicability can be across all stakeholders. To that end, OmniComm Systems developed Dynamic Report Data Grids, part of the TrialMaster EDC suite, that allows for the fast and simple creation of aggregated data views that can include any relevant data from within the clinical trial. When an investigator or other user is working within the interface, they can call up a Dynamic Report Data Grid at any point, executing at the patient, site or trial level as their privileges allow. The Data Grid provides additional sorting and filtering capabilities if required. With this capability an investigator can call up a serious adverse events summary, review patient self-assessments or key endpoint variables as required and they have fast, targeted data access at their fingertips. The use cases are boundless, so there’s no reason why monitors, data managers, medical reviewers and other stakeholders can’t add Dynamic Report Data Grids to their toolkit of data access options too!