The collection and use of eSource clinical data is rapidly becoming the standard medium for clinical research. Regulatory authorities have been increasingly more vocal of their support for the use of eSource clinical data, a fact that may be helping in the continued adoption of eSource and electronic data capture in general during the conduct and assessment of clinical research.

This symposium will introduce risk-based approaches when electronic data are intended to serve as the source of clinical data. Additionally, we will discuss how monitors and data managers can work together when developing and implementing a risk-based monitoring program. A final topic is the assessment of electronic health record systems that will be the repository of eSource data.