4.2.5 Rationale for Adaptive or Novel Trial Design
https://w3id.org/m11-rdf/C217272.C218541
- Definition
- Section 4.2.5 of the ICH M11 Protocol standard, Rationale for Adaptive or Novel Trial Design.
- Section number
- 4.2.5
- Broader
- 4.2 Rationale for Trial Design
- NCIt concept
- http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C218541 (EVS identifier)
NCIT_C218541 (OBO PURL) - EVS term
- http://rdf.ich.org/ich-terminology#C217272.C218541 (EVS term IRI; does not resolve)
Elements specified in this section
| Element | IRI | Conformance | TS block |
|---|---|---|---|
| Rationale for Adaptive or Novel Trial Design | C217345.C218733 | Conditional: when <Overall Rationale for Trial Design> is not used | 247 |
In the ICH M11 Template
- Heading
- Rationale for Adaptive or Novel Trial Design optional
- Page
- p. 32
- Heading is
- Rationale for Adaptive or Novel Trial Design (TS term, section)
| Field | Template | Page | Realises | Linked by |
|---|---|---|---|---|
<Enter Rationale for Adaptive or Novel Trial Design> | optional | p. 32 | Rationale for Adaptive or Novel Trial Design | ts-term / verb-dropped / 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.