11.6 Risk-Based Quality Management
https://w3id.org/m11-rdf/C217272.C218659
- Definition
- Section 11.6 of the ICH M11 Protocol standard, Risk-Based Quality Management.
- Section number
- 11.6
- Broader
- 11 TRIAL OVERSIGHT AND OTHER GENERAL CONSIDERATIONS
- NCIt concept
- http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C218659 (EVS identifier)
NCIT_C218659 (OBO PURL) - EVS term
- http://rdf.ich.org/ich-terminology#C217272.C218659 (EVS term IRI; does not resolve)
Elements specified in this section
| Element | IRI | Conformance | TS block |
|---|---|---|---|
| Risk-Based Quality Management | C217352.C218821 | Required | 524 |
In the ICH M11 Template
- Heading
- Risk-Based Quality Management
- Page
- p. 61
- Heading is
- Risk-Based Quality Management (TS term, section)
| Field | Template | Page | Realises | Linked by |
|---|---|---|---|---|
<Enter Risk-Based Quality Management> | p. 61 | Risk-Based Quality Management | 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.