Population Diagnosis or Condition
https://w3id.org/m11-rdf/C217342.C112038
- Definition
- A description of the condition, disease or disorder that the clinical trial is intended to investigate or address.
- Namespace
- ICH M11 Section 1 Terminology
- ICH pair
2.16.840.1.113883.3.989.2.3.3.1+C112038(stated in the Technical Specification)- NCIt concept
- http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C112038 (EVS identifier)
NCIT_C112038 (OBO PURL) - EVS term
- http://rdf.ich.org/ich-terminology#C217342.C112038 (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 |
|---|---|---|---|---|---|---|---|
| 105 | [Population Diagnosis or Condition] | 1.1.2 Overall Design | Required | One to one; One to Heading; One to Sponsor Protocol Identifier | Valid Value or Text (V or D) | Yes, repeatable for each population diagnosis or condition |
In the ICH M11 Template
| Section | Field | Template | Page | Linked by |
|---|---|---|---|---|
| 1.1.2 Overall Design 1.1.2 | [Population Diagnosis or Condition] | p. 22 | ts-term / exact / 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 67 | Indication-label stated: Indication.label (attribute name) | by-code | StudyVersion/@studyDesigns/StudyDesign/@indications/Indication/@label | |
| CDISC DDF-RA v4.0.0 row 72 | Indication-label stated: Indication.label (attribute name) | by-code | StudyVersion/@studyDesigns/StudyDesign/@indications/Indication/@label |
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.