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
| Page standards status: Informative |
version: 5; Last updated: 2026-05-30 21:02:29+0000
Profile: http://hl7.org/fhir/uv/pharmaceutical-research-protocol/StructureDefinition/m11-research-study-profile
ArtifactPublicationStatus: Active
Artifact Author: Brian S. Alper, MD, MSPH:
url: https://fevir.net/resources/ResearchStudy/568025
identifier: FEvIR Object Identifier/568025, [To be replaced]
title: M11ResearchStudy Template
citeAs:
M11ResearchStudy Template [Database Entry: FHIR ResearchStudy Resource]. Contributors: Brian S. Alper, MD, MSPH [Authors/Creators]. In: Fast Evidence Interoperability Resources (FEvIR) Platform, FOI 568025. Revised 2026-05-30. Available at: https://fevir.net/resources/ResearchStudy/568025. Computable resource at: https://fevir.net/resources/ResearchStudy/568025#json.
| Type | Target[x] |
| Supported With | M11 Report for M11ResearchStudy Template |
status: Active
description:
This instance of M11ResearchStudy Profile is created to support a set of Composition Profiles to represent the M11 Report Template Instructions.
| Eligibility |
| StudyEligibilityCriteria for M11Report Example |
objective
name: Primary Objective 1: [Replace with short label.]
type: Primary
description:
[Replace with description for a primary objective.]
OutcomeMeasures
Name Description Endpoint [Replace with short label for an outcome measure.] [Replace with description for an outcome measure.]
[Replace with reference to an EvidenceVariable (VariableDefinition Profile)for a structured definition of an outcome measure.]
objective
name: Secondary Objective 1: [Replace with short label.]
type: Secondary
description:
[Replace with description for a secondary objective.]
OutcomeMeasures
Name Description Endpoint [Replace with short label for an outcome measure.] [Replace with description for an outcome measure.]
[Replace with reference to an EvidenceVariable (VariableDefinition Profile)for a structured definition of an outcome measure.]