Sponsor Approval Date
https://w3id.org/m11-rdf/C217353.C132352
- Definition
- The date that the sponsor approved a version of the protocol.
- Namespace
- ICH M11 Section 12 Terminology
- ICH pair
2.16.840.1.113883.3.989.2.3.3.12+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#C217353.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 |
|---|---|---|---|---|---|---|---|
| 556 | <Sponsor Approval Date> | 12.3 Prior Protocol Amendment(s) | Required | One to one | Date (D) | Yes, reuse from the title page or other previous amendment | |
| 563 | <Sponsor Approval Date> | 12.3 Prior Protocol Amendment(s) | Conditional: if amendment | One to one | Date (D) | Yes, repeatable one table per amendment |
In the ICH M11 Template
| Section | Field | Template | Page | Linked by |
|---|---|---|---|---|
| 12.3 Prior Protocol Amendment(s) 12.3 | <Enter Sponsor Approval Date> | p. 65 | ts-term / verb-dropped / section | |
| 12.3 Prior Protocol Amendment(s) 12.3 | <Enter Sponsor Approval Date> | p. 65 | ts-term / verb-dropped / section | |
| 12.3 Prior Protocol Amendment(s) 12.3 | <enter Sponsor Approval Date> | conditional | p. 66 | ts-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.