Following the release of the 2011 draft Guidance for Industry Oversight of Clinical Investigations-A Risk-Based Approach to Monitoring, sponsors are looking for more ways to implement this approach that will mutually benefit the sites and sponsors without jeopardizing the safety of the subjects and the quality of the data. One suggestion that has been noted in the field leans toward hospitals allowing monitors access to electronic medical records (EMR) to monitor remotely.
Topics: Risk-Based Monitoring, EMR Access, Hospitals

