ICH M11 Section Amendment Details Terminology
https://w3id.org/m11-rdf/C217357
- Kind
- Namespace (section code list)
- ICH OID
2.16.840.1.113883.3.989.2.3.3.15(OID Listing, 2025-10-16)- Definition
- Terminology relevant to the data elements in the amendment details section of the ICH M11 protocol template.
- Section
- Amendment Details
- NCIt concept
- http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C217357 (EVS identifier)
NCIT_C217357 (OBO PURL) - EVS code list
- http://rdf.ich.org/ich-terminology#C217357 (EVS term IRI; does not resolve)
Elements (14)
| Element | IRI |
|---|---|
| Other description | C217357.C17649 |
| Brief Rationale for Change | C217357.C181233 |
| Approximately <#/%> enrolled | C217357.C218478 |
| Section # and Name | C217357.C218479 |
| Description of Change | C217357.C218483 |
| Amendment Details | C217357.C218694 |
| Amendment Scope Enrollment Definition | C217357.C218695 |
| Primary Reason for Amendment | C217357.C218696 |
| Secondary Reason for Amendment | C217357.C218697 |
| Is this amendment likely to have a substantial impact on the safety or rights of the participants? | C217357.C218698 |
| Briefly Explain Substantial Impact On Safety | C217357.C218699 |
| Is this amendment likely to have a substantial impact on the reliability and robustness of the data generated in the clinical trial? | C217357.C218700 |
| Briefly Explain Substantial Impact on Data | C217357.C218701 |
| Amendment Summary | C217357.C42581 |
Draft, not normative. A derived rendering of the ICH M11 Technical Specification, Template, code lists and OID Listing (© ICH, used under the ICH Legal Mentions) and of the ICH M11 Terminology published by NCI EVS (CC BY 4.0). Not an ICH, CDISC or HL7 artifact, and not endorsed or sponsored by ICH.