3.1 Primary Objective(s) and Associated Estimand(s)
https://w3id.org/m11-rdf/C217272.C218527
- Definition
- Section 3.1 of the ICH M11 Protocol standard, Primary Objective(s) and Associated Estimand(s).
- Section number
- 3.1
- Broader
- 3 TRIAL OBJECTIVES AND ASSOCIATED ESTIMANDS
- NCIt concept
- http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C218527 (EVS identifier)
NCIT_C218527 (OBO PURL) - EVS term
- http://rdf.ich.org/ich-terminology#C217272.C218527 (EVS term IRI; does not resolve)
Subsections
Elements specified in this section
| Element | IRI | Conformance | TS block |
|---|---|---|---|
| Primary Objective | C217344.C85826 | Required | 176 |
| Population | C217344.C70833 | Conditional: If there is a population as estimand characteristic | 180 |
| Treatment | C217344.C49236 | Conditional: If there is a treatment as estimand characteristic | 182 |
| Endpoint | C217344.C25212 | Required | 184 |
| Population-level Summary | C217344.C188853 | Conditional: If there is a population-level summary as estimand | 186 |
| Description of Intercurrent Event | C217344.C188856 | Conditional: If there is one or more other intercurrent events as estimand characteristic. | 189 |
| Intercurrent Event Strategy | C217344.C188857 | Conditional: If there is one or more other intercurrent events as estimand characteristic. | 190 |
In the ICH M11 Template
- Heading
- Primary Objective(s) and Associated Estimand(s)
- Page
- p. 27
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.