Inclusion Criterion
https://w3id.org/m11-rdf/C217346.C25532
- Definition
- The criteria in a protocol that prospective participants must meet to be eligible for participation in a study. (CDISC glossary)
- Namespace
- ICH M11 Section 5 Terminology
- ICH pair
2.16.840.1.113883.3.989.2.3.3.5+C25532(stated in the Technical Specification)- NCIt concept
- http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C25532 (EVS identifier)
NCIT_C25532 (OBO PURL) - EVS term
- http://rdf.ich.org/ich-terminology#C217346.C25532 (EVS term IRI; does not resolve)
- Label from
- ICH M11 Terminology, NCI EVS, release 2025-12-19
Specifications in the Technical Specification
One row per component block of Appendix 1 that names this element. Text as printed.
| Block | Term | Section | Conformance | Cardinality | Data type | Value code list | Repeating / reuse |
|---|---|---|---|---|---|---|---|
| 266 | <Inclusion Criterion> | 5.2 Inclusion Criteria | Required | One to one | Text (D) | Yes, number consecutively, repeatable for each Inclusion Criterion. If deleted for an amendment, do not replace and do not duplicate |
In the ICH M11 Template
| Section | Field | Template | Page | Linked by |
|---|---|---|---|---|
| 5.2 Inclusion Criteria 5.2 | <Enter Inclusion Criterion> | p. 34 | ts-term / verb-dropped / section |
Mapping statements to USDM v4
One row per published mapping row that names this element (SSSOM record). The link to the USDM attribute is the mapping publisher's; how the row was tied to this element is in the third column. Paths as given.
| Source | USDM attribute (usdm-rdf) | Identified | Target path | Condition |
|---|---|---|---|---|
| HL7 CSP IG ballot row 170 | SyntaxTemplate-text stated: EligibilityCriterionItem.text (attribute name, inherited) | by-code | StudyVersion/@studyDesigns/StudyDesign/@eligibiliyCriteria/EligibilityCriterion/@text | StudyVersion/@studyDesigns/StudyDesign/@eligibilityCriteria/EligibilityCriterion/@category="C25532" |
| CDISC DDF-RA v4.0.0 row 174 | SyntaxTemplate-text stated: EligibilityCriterionItem.text (attribute name, inherited) | by-code | StudyVersion/@studyDesigns/StudyDesign/@eligibiliyCriteria/EligibilityCriterion/@text | StudyVersion/@studyDesigns/StudyDesign/@eligibilityCriteria/EligibilityCriterion/@category="C25532" |
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.