2.2.2 Benefit Summary
https://w3id.org/m11-rdf/C217272.C218524
- Definition
- Section 2.2.1 of the ICH M11 Protocol standard, Benefit Summary.
- Section number
- 2.2.1
- Broader
- 2.2 Assessment of Risks and Benefits
- NCIt concept
- http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C218524 (EVS identifier)
NCIT_C218524 (OBO PURL) - EVS term
- http://rdf.ich.org/ich-terminology#C217272.C218524 (EVS term IRI; does not resolve)
Elements specified in this section
| Element | IRI | Conformance | TS block |
|---|---|---|---|
| Trial-specific Intervention Risks and Mitigations | C217343.C218721 | Optional | 166 |
| Trial-specific Procedure Risks and Mitigations | C217343.C218722 | Optional | 167 |
| Trial-specific Other Risks and Mitigations | C217343.C218723 | Optional | 168 |
In the ICH M11 Template
- Heading
- Risk Summary and Mitigation Strategy optional
- Page
- p. 26
| Field | Template | Page | Realises | Linked by |
|---|---|---|---|---|
<Enter Trial-specific Intervention Risks and Mitigations> | optional | p. 26 | Trial-specific Intervention Risks and Mitigations | ts-term / verb-dropped / section |
<Enter Trial-specific Procedure Risks and Mitigations> | optional | p. 26 | Trial-specific Procedure Risks and Mitigations | ts-term / verb-dropped / section |
<Enter Trial-specific Other Risks and Mitigations> | optional | p. 26 | Trial-specific Other Risks and Mitigations | 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.