Paperless Clinical Trials – eSource
Conducting a clinical trial is an incredibly labour intensive operation, with a large proportion of the clinical trial budget attributed to the costs associated with verifying source data against the study case report forms (monitoring).
With the trend towards electronic source records, monitors now have the ability to source data verify clinical trial data without stepping foot in the research centre or institution. Many hospital’s medical records are now available electronically and these facilities are looking to provide remote access to monitors for the purpose of source data verification.
In addition to electronic medical records, some sponsors are following the FDA guidelines on electronic source data in clinical investigations allowing all data collected for a clinical trial to be collected and stored electronically.
With clinical trial data collected electronically and medical records being available electronically monitors will be able to conduct monitoring visits for source data verification form the office instead of at the site, reducing the overall costs associated with traditional monitoring visits.