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 Reason for Amendment Value Set Terminology

Official URL: http://hl7.org/fhir/uv/clinical-study-protocol/ValueSet/m11-study-amendment-reason-vs | Version: 1.0.0-ballot2 | Highlight text changes?
Standards status: Trial-use Active as of 2026-04-09 | Maturity Level: 0 | Computable Name: M11StudyAmendmentReasonVS
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 reason for amendment value set codelist of the ICH M11 protocol template. This is ICH M11 Value Set C217276 drawn from the NCI Thesaurus and represented here in FHIR format.

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
  C218497 | Change in Standard Of Care Amendment Reason | A change in the standard of care necessitates a change(s) to, or formal clarification of, the protocol.
  C218496 | Change in Strategy Amendment Reason | A change in the study purpose or intent of the scientific plan necessitates a change(s) to, or formal clarification of, the protocol.
  C218495 | IMP Addition Amendment Reason | The addition of an investigational medicinal product to a clinical trial design necessitates a change(s) to, or formal clarification of, the protocol.
  C218501 | Inconsistency and/or Error in the Protocol Amendment Reason | An error or inconsistency in the protocol necessitates a change(s) to, or formal clarification of, the protocol.
  C218499 | Investigator/Site Feedback Amendment Reason | Feedback from the investigator or study site necessitates a change(s) to, or formal clarification of, the protocol.
  C218492 | IRB/IEC Feedback Amendment Reason | Feedback from the institutional review board or independent ethics committee necessitates a change(s) to, or formal clarification of, the protocol.
  C218494 | Manufacturing Change Amendment Reason | A change to manufacturing processes of the study agents necessitates a change(s) to, or formal clarification of, the protocol.
  C218498 | New Data Available (Other Than Safety Data) Amendment Reason | Previously unavailable data (other than safety data) becomes available, which necessitates a change(s) to, or formal clarification of, the protocol.
  C218491 | New Regulatory Guidance Amendment Reason | A regulatory agency has published a guidance document that necessitates a change(s) to, or formal clarification of, the protocol.
  C218493 | New Safety Information Available Amendment Reason | Previously unavailable safety data becomes available, which necessitates a change(s) to, or formal clarification of, the protocol.
  C48660 | Not Applicable | Determination of a value is not relevant in the current context.
  C17649 | Other | Different than the one(s) previously specified or mentioned.
  C218502 | Protocol Design Error Amendment Reason | A protocol design error necessitates a change(s) to, or formal clarification of, a document.
  C218500 | Recruitment Difficulty Amendment Reason | Challenges with participant recruitment necessitates a change(s) to, or formal clarification of, the protocol.
  C218490 | Regulatory Agency Request to Amend Amendment Reason | A regulatory agency has expressed a need for a change(s) to, or formal clarification of, the protocol.

### Expansion

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

This value set contains 15 concepts

System | Code | Display (en) | Definition | JSON | XML
`http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl` | C218497 | Change in Standard Of Care Amendment Reason | A change in the standard of care necessitates a change(s) to, or formal clarification of, the protocol. |  |
`http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl` | C218496 | Change in Strategy Amendment Reason | A change in the study purpose or intent of the scientific plan necessitates a change(s) to, or formal clarification of, the protocol. |  |
`http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl` | C218495 | IMP Addition Amendment Reason | The addition of an investigational medicinal product to a clinical trial design necessitates a change(s) to, or formal clarification of, the protocol. |  |
`http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl` | C218501 | Inconsistency and/or Error in the Protocol Amendment Reason | An error or inconsistency in the protocol necessitates a change(s) to, or formal clarification of, the protocol. |  |
`http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl` | C218499 | Investigator/Site Feedback Amendment Reason | Feedback from the investigator or study site necessitates a change(s) to, or formal clarification of, the protocol. |  |
`http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl` | C218492 | IRB/IEC Feedback Amendment Reason | Feedback from the institutional review board or independent ethics committee necessitates a change(s) to, or formal clarification of, the protocol. |  |
`http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl` | C218494 | Manufacturing Change Amendment Reason | A change to manufacturing processes of the study agents necessitates a change(s) to, or formal clarification of, the protocol. |  |
`http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl` | C218498 | New Data Available (Other Than Safety Data) Amendment Reason | Previously unavailable data (other than safety data) becomes available, which necessitates a change(s) to, or formal clarification of, the protocol. |  |
`http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl` | C218491 | New Regulatory Guidance Amendment Reason | A regulatory agency has published a guidance document that necessitates a change(s) to, or formal clarification of, the protocol. |  |
`http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl` | C218493 | New Safety Information Available Amendment Reason | Previously unavailable safety data becomes available, which necessitates a change(s) to, or formal clarification of, the protocol. |  |
`http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl` | C48660 | Not Applicable | Determination of a value is not relevant in the current context. |  |
`http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl` | C17649 | Other | Different than the one(s) previously specified or mentioned. |  |
`http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl` | C218502 | Protocol Design Error Amendment Reason | A protocol design error necessitates a change(s) to, or formal clarification of, a document. |  |
`http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl` | C218500 | Recruitment Difficulty Amendment Reason | Challenges with participant recruitment necessitates a change(s) to, or formal clarification of, the protocol. |  |
`http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl` | C218490 | Regulatory Agency Request to Amend Amendment Reason | A regulatory agency has expressed a need for a change(s) to, or formal clarification of, the protocol. |  |

Description of the above table(s).