Vulcan Real World Data FHIR Implementation Guide (Jira PSS-2008)

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. 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. The destination format currently being used for this project is the SDTM (Study Data Tabulation Model) standard, created by the Clinical Data Interchange Standards Consortium (CDISC) standards development organization, which optimized for clinical research and regulatory uses and is the data standard used for regulatory submissions of study data to the US Food and Drug Administration. The intent is for future iterations of the Implementation Guide to have a wider scope of RWD such as from Registries, Payer systems, and HIEs.