9.4 Special Safety Situations
https://w3id.org/m11-rdf/C217272.C218624
- Definition
- Section 9.4 of the ICH M11 Protocol standard, Special Safety Situations.
- Section number
- 9.4
- Broader
- 9 ADVERSE EVENTS, SERIOUS ADVERSE EVENTS, PRODUCT COMPLAINTS, PREGNANCY AND POSTPARTUM INFORMATION, AND SPECIAL SAFETY SITUATIONS
- NCIt concept
- http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C218624 (EVS identifier)
NCIT_C218624 (OBO PURL) - EVS term
- http://rdf.ich.org/ich-terminology#C217272.C218624 (EVS term IRI; does not resolve)
Elements specified in this section
| Element | IRI | Conformance | TS block |
|---|---|---|---|
| Special Safety Situations | C217350.C218800 | Required | 458 |
In the ICH M11 Template
- Heading
- Special Safety Situations
- Page
- p. 54
- Heading is
- Special Safety Situations (TS term, section)
| Field | Template | Page | Realises | Linked by |
|---|---|---|---|---|
<Enter Special Safety Situations> | p. 54 | Special Safety Situations | 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.