11.11 Early Site Closure
https://w3id.org/m11-rdf/C217272.C218664
- Definition
- Section 11.11 of the ICH M11 Protocol standard, Early Site Closure.
- Section number
- 11.11
- Broader
- 11 TRIAL OVERSIGHT AND OTHER GENERAL CONSIDERATIONS
- NCIt concept
- http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C218664 (EVS identifier)
NCIT_C218664 (OBO PURL) - EVS term
- http://rdf.ich.org/ich-terminology#C217272.C218664 (EVS term IRI; does not resolve)
Elements specified in this section
| Element | IRI | Conformance | TS block |
|---|---|---|---|
| Decision Rights for Site Closure | C217352.C218828 | Required | 537 |
| Criteria for Early Closure | C217352.C218829 | Required | 538 |
| Responsibilities Following Early Site Closure | C217352.C218830 | Required | 539 |
In the ICH M11 Template
- Heading
- Early Site Closure
- Page
- p. 62
| Field | Template | Page | Realises | Linked by |
|---|---|---|---|---|
<Enter Decision Rights for Site Closure> | p. 62 | Decision Rights for Site Closure | ts-term / verb-dropped / section | |
<Enter Criteria for Early Closure> | p. 62 | Criteria for Early Closure | ts-term / verb-dropped / section | |
<Enter Responsibilities Following Early Site Closure> | p. 62 | Responsibilities Following Early Site Closure | 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.