There Is More To CDMS Than EDC

By Richard Young

When electronic data capture (EDC) first appeared 30 to 40 years ago, it was a hugely disruptive technology for clinical data management, and over time, EDC became the primary tool for data collection and management. Unfortunately, the needs of each data contributor and consumer were merged, as one set of features defined not only the user experience but also the content (i.e., data experience). Principal investigators and site staff entering data would use the same defined page layout to enter data that CRAs used for monitoring and data managers used for data cleaning.

If we explore the total experience of a clinical trial, it is easy to see the flaws in this plan. Different users need to view and interact with data differently, and those needs define their user requirements. Traditional EDC solutions do not offer customized, or role-based experiences, but rather compromise — prioritizing one user’s preferences over another.