Validating electronic source data in clinical trials

Abstract

The clinical trials industry relies heavily on paper-based source documents as the foundation for the collection of its clinical research data from human subjects and medical records. This focus on paper documents has been prevalent throughout the history of clinical trials conduct, even as computing solutions advanced throughout the past 20 years. With the advent of additional electronic capabilities recently with the growth of Internet-based products to enhance business operations in many fields, the clinical trials industry remains uniquely behind most other industries in electronic technology adoptions. Valid reasons exist for the slow growth of technology adoptions in clinical trial activities, but there are now discussions about how to use technology more effectively in clinical trial conduct. One area of enhanced clinical trial conduct is believed to be available by moving from paper-based source documents to electronic source documents, that is, eliminating paper from clinical data capture, and collecting the information initially in a computer system. An important concern in moving to electronic source data is the validation of such data. This paper summarizes the history of clinical data capture through paper and electronic advancements to date and identifies three reasons for the slow movement to more electronic source data. The paper then illustrates two methods for the validation of electronic source data.