This project aims to develop a FHIR Implementation Guide that defines FHIR profiles that can be used to retrieve relevant research data from Real World Data sources – specifically Electronic Health Record (EHR) systems - and ultimately transform that data into a format suitable for submission to pharmaceutical regulatory agencies. In addition this project also aims to demonstrate how HL7 FHIR can directly support clinical research and regulatory uses. Our intent is to be a Universal project and we will be looking at the International Patient Summary (IPS) project for a baseline dataset from which to build our profiles. The profiles built by this project will enhance the IPS profiles for the purposes of conveying data needed for clinical research.