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 Enrollment Description Value Set Terminology

Official URL: http://hl7.org/fhir/uv/clinical-study-protocol/ValueSet/m11-amendment-scope-enrollment-vs | Version: 1.0.0-ballot2 | Highlight text changes?
Standards status: Trial-use Active as of 2026-04-09 | Maturity Level: 0 | Computable Name: M11AmendmentScopeEnrollmentVS
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 enrollment description value set codelist of the ICH M11 protocol template. This is ICH M11 Value Set C217275 drawn from the NCI Thesaurus and represented here in FHIR format.

References

- M11_AmendmentScopeImpact

### 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
  C218489 | By Cohort | Covering or affecting a cohort of individuals.
  C68846 | Global | Covering or affecting the whole of a system.
  C41065 | Locally | To a restricted area (of the body).

### 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` | C218489 | By Cohort | Covering or affecting a cohort of individuals. |  |
`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` | C41065 | Locally | To a restricted area (of the body). |  |

Description of the above table(s).