4.2 Rationale for Trial Design
https://w3id.org/m11-rdf/C217272.C218536
- Definition
- Section 4.2 of the ICH M11 Protocol standard, Rationale for Trial Design.
- Section number
- 4.2
- Broader
- 4 TRIAL DESIGN
- NCIt concept
- http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C218536 (EVS identifier)
NCIT_C218536 (OBO PURL) - EVS term
- http://rdf.ich.org/ich-terminology#C217272.C218536 (EVS term IRI; does not resolve)
Subsections
- 4.2.1 Rationale for Estimand(s)
- 4.2.2 Rationale for Intervention Model
- 4.2.3 Rationale for Control Type
- 4.2.4 Rationale for Trial Duration
- 4.2.5 Rationale for Adaptive or Novel Trial Design
- 4.2.6 Rationale for Interim Analysis
- 4.2.7 Rationale for Other Trial Design Aspects
Elements specified in this section
| Element | IRI | Conformance | TS block |
|---|---|---|---|
| Overall Rationale for Trial Design | C217345.C142705 | Conditional: If Level 3 subheadings are not used | 237 |
In the ICH M11 Template
- Heading
- Rationale for Trial Design
- Page
- p. 31
| Field | Template | Page | Realises | Linked by |
|---|---|---|---|---|
<Enter Overall Rationale for Trial Design> | conditional | p. 31 | Overall Rationale for 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.