Genetics, Genomics, Pharmacogenetics and Pharmacogenomics

https://w3id.org/m11-rdf/C217349.C218777

Definition
A narrative description containing information about the collection, use, and retention of biospecimens, and their use in genetic, genomic, pharmacogenetic and pharmacogenomic biomarker assessments within the trial.
Namespace
ICH M11 Section 8 Terminology
ICH pair
2.16.840.1.113883.3.989.2.3.3.8 + C218777 (stated in the Technical Specification)
NCIt concept
http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C218777 (EVS identifier)
NCIT_C218777 (OBO PURL)
EVS term
http://rdf.ich.org/ich-terminology#C217349.C218777 (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.

BlockTermSectionConformanceCardinalityData typeValue code listRepeating / reuse
395<Genetics, Genomics, Pharmacogenetics and Pharmacogenomics>8.6.1 Genetics, Genomics, Pharmacogenetics and PharmacogenomicsRequiredOne to oneText (D)No

In the ICH M11 Template

The Template heading of 8.6.1 Genetics, Genomics, Pharmacogenetics and Pharmacogenomics is this element.

SectionFieldTemplatePageLinked by
8.6.1 Genetics, Genomics, Pharmacogenetics and Pharmacogenomics 8.6.1<Enter Genetics, Genomics, Pharmacogenetics and Pharmacogenomics>p. 48ts-term / verb-dropped / section

Mapping statements to USDM v4

None: no row of the two pinned mappings is identified with this element and resolves in USDM v4.0.0.

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.