Route of Administration
https://w3id.org/m11-rdf/C217347.C38114
- Definition
- Path by which the pharmaceutical product is taken into or makes contact with the body.
- Namespace
- ICH M11 Section 6 Terminology
- ICH pair
2.16.840.1.113883.3.989.2.3.3.6+C38114(stated in the Technical Specification)- NCIt concept
- http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C38114 (EVS identifier)
NCIT_C38114 (OBO PURL) - EVS term
- http://rdf.ich.org/ich-terminology#C217347.C38114 (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 |
|---|---|---|---|---|---|---|---|
| 310 | <Route of Administration> | 6 TRIAL INTERVENTION AND CONCOMITANT THERAPY | Optional: if the table used | One to each Intervention Name and Pharmaceutical Dose Form | Valid Value (V) | Yes, repeatable for each Intervention Name, Pharmaceutical Dose Form, per Arm Name |
In the ICH M11 Template
| Section | Field | Template | Page | Linked by |
|---|---|---|---|---|
| 6 TRIAL INTERVENTION AND CONCOMITANT THERAPY 6 | [Select Route of Administration] | optional | p. 37 | 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 191 | Administration-route stated: Administration.route (attribute name) | by-code | StudyVersion/@studyDesigns/StudyDesign/@studyCells/StudyCell/@elements/StudyElement/@studyInterventions/StudyIntervention/@administrations/Administration/@route/AliasCode/@standardCode/Code/@decode | StudyVersion/@studyDesigns/StudyDesign/@arms/StudyArm/@id=StudyVersion/@studyDesigns/StudyDesign/@studyCells/StudyCell/@arm |
| CDISC DDF-RA v4.0.0 row 194 | Administration-route stated: Administration.route (attribute name) | by-code | StudyVersion/@studyDesigns/StudyDesign/@studyCells/StudyCell/@elements/StudyElement/@studyInterventions/StudyIntervention/@administrations/Administration/@route/AliasCode/@standardCode/Code/@decode | StudyVersion/@studyDesigns/StudyDesign/@arms/StudyArm/@id=StudyVersion/@studyDesigns/StudyDesign/@studyCells/StudyCell/@arm |
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.