11.1 Regulatory and Ethical Considerations
https://w3id.org/m11-rdf/C217272.C218650
- Definition
- Section 11.1 of the ICH M11 Protocol standard, Regulatory and Ethical Considerations.
- Section number
- 11.1
- Broader
- 11 TRIAL OVERSIGHT AND OTHER GENERAL CONSIDERATIONS
- NCIt concept
- http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C218650 (EVS identifier)
NCIT_C218650 (OBO PURL) - EVS term
- http://rdf.ich.org/ich-terminology#C217272.C218650 (EVS term IRI; does not resolve)
Elements specified in this section
| Element | IRI | Conformance | TS block |
|---|---|---|---|
| Regulatory and Ethical Considerations | C217352.C218811 | Required | 504 |
In the ICH M11 Template
- Heading
- Regulatory and Ethical Considerations
- Page
- p. 59
- Heading is
- Regulatory and Ethical Considerations (TS term, section)
| Field | Template | Page | Realises | Linked by |
|---|---|---|---|---|
<Enter Regulatory and Ethical Considerations> | p. 60 | Regulatory and Ethical Considerations | 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.