This forum will begin with a brief overview of current readiness for EHRs to support regulated research and provide an opportunity for open discussion with representatives of FDA and the HHS in terms of their views on the use of EHRs for regulated research and the concerns that have discouraged research sponsors from bringing this available opportunity into reality. A challenge will be issued to sponsors to bring a protocol forward to use EHRs for clinical research in an actual regulated research study. The forum will also discuss value and opportunities for sponsors who lead the way for the industry in leveraging EHRs to increase research capacity and efficiency.

Learning Objectives:
Recognize the readiness of EHRs to support regulated research and the potential value of EHRs for clinical research
Describe the requirement for regulated research in terms of electronic source (eSource) data interchange and validation when using EHRs for eSource
Identify where clinical research fits into the increasing use of EHRs for healthcare around the world and participate in issuing the challenge.