HL7 FHIR Implementation Guide: Retrieval of Real World Data for Clinical Research v1.0.0

This document helps define a minimal set of clinical research Fast Healthcare Interoperability Resources (FHIR) profiles and elements for use in electronic health record (EHR) systems that can be used for real-world data in an interoperable and consistent manner for clinical research objectives. In this context, real-world data refer to data captured in routine health care rather than data captured in controlled clinical trials. A number of case studies were used to determine what data elements would be needed. The standard is intended to provide data representations that will support real-world data research. It is also intended to facilitate downstream use for submissions to pharmaceutical regulatory agencies, but downstream use of retrieved data is not covered in this guide. This document is part of the Retrieval of Real World Data for Clinical Research based on FHIR Release 4.

Main sections:

- Home

- Cohort building

- Finding data

- Technical considerations

- Determining usage from medication resources

- Downloads

- Acknowledgements

- Related references

- Acute coronary syndrome study

- Anti-TNFa treatment study

- Diabetes study

- COVID-19 vaccine effectiveness study

- Artifacts summary