Participants Who Become Pregnant During the Trial
https://w3id.org/m11-rdf/C217350.C218798
- Definition
- A description of the processes and procedures used to collect pregnancy data for a trial participant who becomes pregnant while the participant is in the trial, as well as data collection about the foetus, neonate, infant, or child.
- Namespace
- ICH M11 Section 9 Terminology
- ICH pair
2.16.840.1.113883.3.989.2.3.3.9+C218798(stated in the Technical Specification)- NCIt concept
- http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C218798 (EVS identifier)
NCIT_C218798 (OBO PURL) - EVS term
- http://rdf.ich.org/ich-terminology#C217350.C218798 (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 |
|---|---|---|---|---|---|---|---|
| 454 | {<Participants Who Become Pregnant During the Trial>} | 9.3.1 Participants Who Become Pregnant During the Trial | Conditional: when collecting pregnancy data for a trial participant who becomes pregnant during the trial. | One to one | Text (D) | No |
In the ICH M11 Template
The Template heading of 9.3.1 Participants Who Become Pregnant During the Trial is this element.
| Section | Field | Template | Page | Linked by |
|---|---|---|---|---|
| 9.3.1 Participants Who Become Pregnant During the Trial 9.3.1 | <Enter Participants Who Become Pregnant During the Trial> | conditional | p. 54 | 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 261 | NarrativeContentItem-text stated: NarrativeContentItem.text (attribute name) | by-unique-name | StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@contentItem/NarrativeContentItem/@text | Study/@documentedBy/StudyDefinitionDocument/@type/Code/@code='C70817' | StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@sectionNumber=<desired section> |
| CDISC DDF-RA v4.0.0 row 262 | NarrativeContentItem-text stated: NarrativeContentItem.text (attribute name) | by-unique-name | StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@contentItem/NarrativeContentItem/@text | Study/@documentedBy/StudyDefinitionDocument/@type/Code/@code='C70817' | StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@sectionNumber=<desired section> |
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.