Many clinical trial teams are tiptoeing into the world of eSource, anxious to reap the benefits, yet uneasy about the impact. To many, the unknowns seem daunting and overwhelming, and perhaps not worth the effort. To those who have taken the plunge, the value to the study team has far outweighed the initial investments. Here are some questions addressed in this paper: What is Source? Why eSource? What problems are solved with eSource? What are the potential challenges? What is the impact on the study team? And, what does the FDA say about all this?
According to the FDA, “initial documentation of data in a clinical study is considered Source documentation or Source data”. This is a fairly straight-forward concept. The source data and documentation is the original record of a data element, and integrity is maintained by using an audit trail to track any changes and modifications.
Now, introduce electronic source “eSource”. For all intents and purposes, the definition is the same, except the original record is captured electronically. This excludes source data that was captured on paper and transcribed into an electronic database. eSource is true to its name and the source data element itself must be electronic; and must be followed with a detailed audit trail as well.