Enabling Regulatory Support For eSource

The FDA has laid out well defined guidelines regarding what is considered eSource data, and how it should be safely managed to achieve regulatory compliance in their 2013 guidance document. Despite the use of eSource being firmly procedurally established for almost a decade, we still regularly encounter clients that are unsure of how to begin implementing eSource into their trials, or are unsure that eSource practices are both supported and encouraged by the FDA. To this end, here is a brief primer on the key points of the 2013 guidance document, and an illustration of how robust EDC systems fully support the operational requirements introduced by the decision to leverage eSource data.