4.1 Description of Trial Design
https://w3id.org/m11-rdf/C217272.C218534
- Definition
- Section 4.1 of the ICH M11 Protocol standard, Description of Trial Design.
- Section number
- 4.1
- Broader
- 4 TRIAL DESIGN
- NCIt concept
- http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C218534 (EVS identifier)
NCIT_C218534 (OBO PURL) - EVS term
- http://rdf.ich.org/ich-terminology#C217272.C218534 (EVS term IRI; does not resolve)
Subsections
Elements specified in this section
| Element | IRI | Conformance | TS block |
|---|---|---|---|
| Overall Description of Trial Design and Description of Intervention Model | C217345.C147139 | Optional | 229 |
| Description of Trial Duration | C217345.C218726 | Optional | 230 |
| Description of Method of Assignment to Trial Intervention | C217345.C219658 | Optional | 231 |
| Description of Level and Method of Blinding | C217345.C218727 | Optional | 232 |
| Additional Description of Trial Design | C217345.C218728 | Optional | 233 |
In the ICH M11 Template
- Heading
- Description of Trial Design
- Page
- p. 30
| Field | Template | Page | Realises | Linked by |
|---|---|---|---|---|
<Enter Overall Description of Trial Design and Description of Intervention Model> | optional | p. 30 | Overall Description of Trial Design and Description of Intervention Model | ts-term / verb-dropped / section |
<Enter Description of Trial Duration> | optional | p. 30 | Description of Trial Duration | ts-term / verb-dropped / section |
<Enter Description of Method of Assignment to Trial Intervention> | optional | p. 30 | Description of Method of Assignment to Trial Intervention | ts-term / verb-dropped / section |
<Enter Description of Level and Method of Blinding> | optional | p. 30 | Description of Level and Method of Blinding | ts-term / verb-dropped / section |
<Enter Additional Description of Trial Design> | optional | p. 31 | Additional Description of 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.