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 Details Statement Value Set Terminology

Official URL: http://hl7.org/fhir/uv/clinical-study-protocol/ValueSet/m11-amendment-details-statement-vs | Version: 1.0.0-ballot2 | Highlight text changes?
Standards status: Trial-use Active as of 2026-04-09 | Maturity Level: 0 | Computable Name: M11AmendmentDetailsStatementVS
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 whether or not a protocol has been amended. This is ICH M11 Value Set C217274 drawn from the NCI Thesaurus and represented here in FHIR format.

References

- M11_ProtocolAmendment
- M11 Research Study Extension

### 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
  C218486 | First Protocol Amendment | This is the first protocol amendment.
  C218485 | Protocol Not Amended | This protocol has not been amended.
  C218488 | Protocol Previously Amended See Summary of Changes Before the Table of Contents | This protocol has been amended previously. The Protocol Amendment Summary of Changes for the current amendment is located directly before the Table of Contents. Prior amendment(s) to this protocol are listed in the table below, beginning with the most recent.
  C218487 | Protocol Previously Amended, Details Presented | This protocol has been amended previously. Details of prior amendments are presented in Section 12.3 Prior Protocol Amendment(s).

### Expansion

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

This value set contains 4 concepts

System | Code | Display (en) | Definition | JSON | XML
`http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl` | C218486 | First Protocol Amendment | This is the first protocol amendment. |  |
`http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl` | C218485 | Protocol Not Amended | This protocol has not been amended. |  |
`http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl` | C218488 | Protocol Previously Amended See Summary of Changes Before the Table of Contents | This protocol has been amended previously. The Protocol Amendment Summary of Changes for the current amendment is located directly before the Table of Contents. Prior amendment(s) to this protocol are listed in the table below, beginning with the most recent. |  |
`http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl` | C218487 | Protocol Previously Amended, Details Presented | This protocol has been amended previously. Details of prior amendments are presented in Section 12.3 Prior Protocol Amendment(s). |  |

Description of the above table(s).