Clinical Study Protocol
1.0.0-ballot2 - STU 1 Ballot2

Clinical Study Protocol - Downloaded Version 1.0.0-ballot2 See the Directory of published versions

## ValueSet: ICH M11 Amendment Scope Value Set Terminology

Official URL: http://hl7.org/fhir/uv/clinical-study-protocol/ValueSet/m11-study-amendment-scope-vs | Version: 1.0.0-ballot2 | Highlight text changes?
Standards status: Trial-use Active as of 2026-04-09 | Maturity Level: 0 | Computable Name: M11AmendmentScopeVS
Copyright/Legal: Portions of this material derives from the ICH M11 Harmonised Guideline CeSHarP. The ICH M11 Harmonised Guideline CeSHarP is copyright ©2025+ International Committee on Harmonisation and is made available under license. CDISC publishes semantics for the ICH M11 protocol data elements and valid value sets. This terminology set is published and stored in the NCI Thesaurus Subset C217023 - ICH M11 Terminology (https://evsexplore.semantics.cancer.gov/evsexplore/subset/ncit/C217023) The NCI Thesaurus is released under the CC BY 4.0 license For more licensing information and links see: licenses.html

Terminology associated with the amendment scope value set codelist of the ICH M11 protocol template. This is ICH M11 Value Set C217047 drawn from the NCI Thesaurus and represented here in FHIR format.

The M11 guidance to "leave blank" if not applicable has to be replaced by an explicit "Not Applicable"

References

- M11_ProtocolAmendment

### Logical Definition (CLD)

- Include these codes as defined in `http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl` version 📦1.0.0-ballot2

  Code | Display | Definition
  C68846 | Global | Covering or affecting the whole of a system.
  C217026 | Not Global | Covering or affecting only a portion of the entire system.
  C48660 | Not Applicable | Determination of a value is not relevant in the current context.

### Expansion

Expansion performed internally based on codesystem Fragment of NCIT Code System v1.0.0-ballot2 (CodeSystem)

This value set contains 3 concepts

System | Code | Display (en) | Definition | JSON | XML
`http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl` | C68846 | Global | Covering or affecting the whole of a system. |  |
`http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl` | C217026 | Not Global | Covering or affecting only a portion of the entire system. |  |
`http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl` | C48660 | Not Applicable | Determination of a value is not relevant in the current context. |  |

Description of the above table(s).