description: Narrative elements associated with a research study following the ICH M11 CeSHarP template.\nThe ICH M11 CeSHarP template for a study protocol specifies the headings to be used to organize protocol content.\nFor a FHIR representation of the protocol to be compliant with this template each of the narrative sections must \nbe organized using these headings. Only if there is material that does not properly belong under one of the M11 \nheadings can additional codes be created.
package_name: hl7.fhir.uv.pharmaceutical
derivation: constraint
name: M11ResearchStudyNarratives
type: Composition
elements:
  type:
    binding: {strength: required, valueSet: 'http://hl7.org/fhir/uv/pharmaceutical-research-protocol/ValueSet/narrative-elements-vs'}
    index: 0
  subject: {short: Reference to the protocol that the narrative refers to, index: 1}
  author:
    type: Reference
    refers: ['http://hl7.org/fhir/StructureDefinition/Organization']
    index: 2
  section:
    elements:
      code:
        short: Identifies the section of the narrative according to M11 codes
        binding: {strength: extensible, valueSet: 'http://hl7.org/fhir/uv/pharmaceutical-research-protocol/ValueSet/m11-section-codes-vs'}
        index: 3
package_version: research-protocol-1.0.0-ballot
class: profile
kind: resource
url: http://hl7.org/fhir/uv/pharmaceutical-research-protocol/StructureDefinition/m11-research-study-narratives
base: http://hl7.org/fhir/StructureDefinition/Composition
version: 1.0.0-ballot