Approval Date
https://w3id.org/m11-rdf/C217356.C132352
- Definition
- The date that the sponsor approved a version of the protocol.
- Namespace
- ICH M11 Section Title Page Terminology
- ICH pair
2.16.840.1.113883.3.989.2.3.3.16+C132352(stated in the Technical Specification)- NCIt concept
- http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C132352 (EVS identifier)
NCIT_C132352 (OBO PURL) - EVS term
- http://rdf.ich.org/ich-terminology#C217356.C132352 (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 |
|---|---|---|---|---|---|---|---|
| 51 | {<Sponsor Approval Date> or <State location where sponsor approval information can be found>} | Title Page | Required | One to one; One to Protocol Identifier; One to Original Protocol One to Amendment Identifier | Date or Text (V) | Yes, Not repeatable reuse to Sponsor Approval Date in Section 12.3 |
In the ICH M11 Template
No Template heading or field is linked to this element.
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 43 | GovernanceDate-dateValue stated: GovernanceDate.dateValue (attribute name) | by-code | StudyDefinitionDocument/@versions/ StudyDefinitionDocumentVersion/@dateValues/GovernanceDate/@dateValue | StudyDefinitionDocument/@type/code/@code="C70817" | StudyDefinitionDocument/@versions/ StudyDefinitionDocumentVersion/@dateValues/GovernanceDate/@type/Code/@code="C71476" |
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.