Patient Reported Outcomes 21 CFR Part 11 Extension Implementation Guide (Release 0.2.2 )

This is the (release 0.2.2) of the PatientReportedOutcomes21CFR11 Implementation Guide, based on FHIR Version 4.0.1. See the Directory of published versions.

Profiles defined as part of the 21 CFR 11 PRO Implementation Guide

Profiles

The PRO FHIR IG does not define any specific new profiles.


Extensions

There are currently no extensions beyond those used in the SDC Questionnaire profile required for the PRO Implementation Guide.