Evidence Based Medicine on FHIR Implementation Guide
1.0.0-ballot3 - STU 1 ballot International flag

Evidence Based Medicine on FHIR Implementation Guide, published by HL7 International / Clinical Decision Support. This guide is not an authorized publication; it is the continuous build for version 1.0.0-ballot3 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/ebm/ and changes regularly. See the Directory of published versions

CodeSystem: ResearchStudy Classifier Code System

Official URL: https://fevir.net/resources/CodeSystem/419455 Version: 1.0.0-ballot3
Standards status: Informative Active as of 2026-01-08 Computable Name: ResearchStudyClassifierCodeSystem
Other Identifiers: FEvIR Object Identifier: FEvIR Object Identifier#419455, OID:2.16.840.1.113883.4.642.40.44.16.8

Copyright/Legal: https://creativecommons.org/licenses/by-nc-sa/4.0/

This CodeSystem is used for common values for the ResearchStudy.classifier element and will likely move to terminology.hl7.org when it is mature.

This Code system is referenced in the definition of the following value sets:

version: 6; Last updated: 2026-01-05 17:01:47+0000

This code system https://fevir.net/resources/CodeSystem/419455 defines the following codes:

CodeDisplayDefinition
fda-regulated-drug FDA regulated drug A medication regulated by the U.S. Food and Drug Administration.
fda-regulated-device FDA regulated device A medical device regulated by the U.S. Food and Drug Administration.
irb-exempt IRB-exempt Human subjects research that is excempt from oversight and monitoring by an institutional review board (IRB).
mpg-paragraph-23b MPG Paragraph 23b Research regulated by a specific German legal requirement (Medizinproduktegesetz MPG Paragraph 23b).
includes-females Includes female subjects Includes female subjects
does-not-include-females Does not include female subjects Does not include female subjects
includes-males Includes male subjects Includes male subjects
does-not-include-males Does not include male subjects Does not include male subjects
includes-vulnerable-population Includes vulnerable populations Includes vulnerable populations
does-not-include-vulnerable-population Does not include vulnerable populations Does not include vulnerable populations
includes-healthy-volunteers Includes healthy volunteers Includes healthy volunteers
does-not-include-healthy-volunteers Does not include healthy volunteers Does not include healthy volunteers
includes-ages-in-utero Includes ages in utero Includes subjects who are not yet born
includes-ages-0-17 Includes ages 0-17 years Includes subjects between birth and 17 years of age (not yet 18 years old)
includes-ages-18-64 Includes ages 18-64 years Includes subjects between 18 and 64 years of age (not yet 65 years old)
includes-ages-65-and-older Includes ages 65 and older Includes subjects aged 65 years and older
includes-preterm-newborns Includes preterm newborns Includes subjects who are preterm newborns (up to gestational age < 37 weeks)
includes-neonates Includes neonates Includes subjects between 0 and 27 days of age
includes-ages-28-day-23-month Includes ages 28 days to 23 months Includes subjects between 28 days and 23 months of age
includes-ages-2-5 Includes ages 2-5 years Includes subjects between 2 and 5 years of age (not yet 6 years old)
includes-ages-6-11 Includes ages 6-11 years Includes subjects between 6 and 11 years of age (not yet 12 years old)
includes-ages-12-17 Includes ages 12-17 years Includes subjects between 12 and 17 years of age (not yet 18 years old)
includes-ages-65-84 Includes ages 65-84 years Includes subjects between 65 and 84 years of age (not yet 85 years old)
includes-ages-85-and-older Includes ages 85 and older Includes subjects aged 85 years and older

Description of the above table(s).