8.4 Safety Assessments and Procedures
https://w3id.org/m11-rdf/C217272.C218594
- Definition
- Section 8.4 of the ICH M11 Protocol standard, Safety Assessments and Procedures.
- Section number
- 8.4
- Broader
- 8 TRIAL ASSESSMENTS AND PROCEDURES
- NCIt concept
- http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C218594 (EVS identifier)
NCIT_C218594 (OBO PURL) - EVS term
- http://rdf.ich.org/ich-terminology#C217272.C218594 (EVS term IRI; does not resolve)
Subsections
- 8.4.1 Physical Examination
- 8.4.2 Vital Signs
- 8.4.3 Electrocardiograms
- 8.4.4 Clinical Laboratory Assessments
- 8.4.5 Pregnancy Testing
- 8.4.6 Suicidal Ideation and Behaviour Risk Monitoring
Elements specified in this section
| Element | IRI | Conformance | TS block |
|---|---|---|---|
| Safety Assessments and Procedures | C217349.C218773 | Required | 378 |
In the ICH M11 Template
- Heading
- Safety Assessments and Procedures
- Page
- p. 46
- Heading is
- Safety Assessments and Procedures (TS term, section)
| Field | Template | Page | Realises | Linked by |
|---|---|---|---|---|
<Enter Safety Assessments and Procedures> | p. 46 | Safety Assessments and Procedures | 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.