Clinical Study Protocol
1.0.0-ballot2 - STU 1 Ballot2 International flag

Clinical Study Protocol, published by HL7 International / Biomedical Research and Regulation. This guide is not an authorized publication; it is the continuous build for version 1.0.0-ballot2 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/vulcan-udp-ig/ and changes regularly. See the Directory of published versions

: UDP Related Artifact Type Value Set

Page standards status: Trial-use Maturity Level: 1

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<ValueSet xmlns="http://hl7.org/fhir">
  <id value="udp-related-artifact-type-vs"/>
  <language value="en"/>
  <text>
    <status value="extensions"/>
    <div xmlns="http://www.w3.org/1999/xhtml"><p class="res-header-id"><b>Generated Narrative: ValueSet udp-related-artifact-type-vs</b></p><a name="udp-related-artifact-type-vs"> </a><a name="hcudp-related-artifact-type-vs"> </a><p>This value set includes codes based on the following rules:</p><ul><li>Import all the codes that are contained in <a href="http://terminology.hl7.org/7.1.0/ValueSet-artifact-relationship-type.html">Artifact Relationship Type</a></li><li>Include these codes as defined in <a href="CodeSystem-ncit-cs.html"><code>http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl</code></a><span title="Version is not explicitly stated, which means it is fixed to the version provided in this specification"> version &#x1F4E6;1.0.0-ballot2</span><table class="none"><tr><td style="white-space:nowrap"><b>Code</b></td><td><b>Display</b></td><td><b>Definition</b></td></tr><tr><td><a href="CodeSystem-ncit-cs.html#ncit-cs-C218694">C218694</a></td><td>Protocol Amendment Details</td><td>Particulars about the protocol amendment, considered individually and in relation to a whole.</td></tr></table></li></ul></div>
  </text>
  <extension
             url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fmm">
    <valueInteger value="1"/>
  </extension>
  <extension
             url="http://hl7.org/fhir/StructureDefinition/structuredefinition-wg">
    <valueCode value="brr"/>
  </extension>
  <extension
             url="http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status">
    <valueCode value="trial-use">
      <extension
                 url="http://hl7.org/fhir/StructureDefinition/structuredefinition-conformance-derivedFrom">
        <valueCanonical
                        value="http://hl7.org/fhir/uv/clinical-study-protocol/ImplementationGuide/hl7.fhir.uv.clinical-study-protocol"/>
      </extension>
    </valueCode>
  </extension>
  <url
       value="http://hl7.org/fhir/uv/clinical-study-protocol/ValueSet/udp-related-artifact-type-vs"/>
  <version value="1.0.0-ballot2"/>
  <name value="UDPRelatedArtifactType"/>
  <title value="UDP Related Artifact Type Value Set"/>
  <status value="active"/>
  <experimental value="false"/>
  <date value="2026-04-02T08:57:07+00:00"/>
  <publisher value="HL7 International / Biomedical Research and Regulation"/>
  <contact>
    <name value="HL7 International / Biomedical Research and Regulation"/>
    <telecom>
      <system value="url"/>
      <value value="http://www.hl7.org/Special/committees/rcrim"/>
    </telecom>
    <telecom>
      <system value="email"/>
      <value value="UDP@HL7Vulcan.org"/>
    </telecom>
  </contact>
  <description
               value="These codes represent the relationship between an artifact and it related target.
There is an HL7 value set for Related Artifact type - this has &quot;extensible&quot; binding.  This will 
be included in this value set.
This is a UDP specific value set using NCIT codes to extend a required HL7 value set.

The HL7 value set does not have the concept of information that is a summary of an amendment that has been applied.
The amends and amended-with concepts talk of content that must be applied to get the final version.  M11 only
wants to know what has been done - it is more of an amendment trail than an actual amendment.  M11 uses a concept
from the NCI Thesaurus which is suitable for use here."/>
  <jurisdiction>
    <coding>
      <system value="http://unstats.un.org/unsd/methods/m49/m49.htm"/>
      <code value="001"/>
      <display value="World"/>
    </coding>
  </jurisdiction>
  <compose>
    <include>
      <valueSet
                value="http://terminology.hl7.org/ValueSet/artifact-relationship-type"/>
    </include>
    <include>
      <system value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
      <concept>
        <code value="C218694"/>
        <display value="Protocol Amendment Details"/>
      </concept>
    </include>
  </compose>
</ValueSet>