Case Study

Lucky CRAs. Getting Automated To-Do Lists For Targeted SDV

By Drew Garty, Chief Technology Officer, Vault CDMS, Veeva Systems

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Data managers at Lotus Clinical Research used to spend hours each week building reports to identify the patients and forms that needed Source Data Verification (SDV) at the next site monitoring visit.

Risk-based monitoring solutions will tell you where to focus, but virtually all EDCs take that information and simply flag the designated fields within each respective case report form. The burden is on the CRA to visually scan every form and item, looking to see what’s flagged for SDV.

This poor usability results from a structural limitation. Traditional EDC architectures are based on case report forms, which made sense in the late 1990s when moving from paper but now constrains how the data are displayed. Regardless of role, everyone looks at data within forms.

To tackle the problem, Veeva Vault EDC introduced QuickView, a dynamic interface that optimizes the display of data by function, allowing users to focus on what matters most. With QuickView, the listings previously created by the data managers at Lotus are now automatically generated within the system itself.

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