11.3 Informed Consent Process
https://w3id.org/m11-rdf/C217272.C218654
- Definition
- Section 11.3 of the ICH M11 Protocol standard, Informed Consent Process.
- Section number
- 11.3
- Broader
- 11 TRIAL OVERSIGHT AND OTHER GENERAL CONSIDERATIONS
- NCIt concept
- http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C218654 (EVS identifier)
NCIT_C218654 (OBO PURL) - EVS term
- http://rdf.ich.org/ich-terminology#C217272.C218654 (EVS term IRI; does not resolve)
Subsections
- 11.3.1 Informed Consent for Rescreening
- 11.3.2 Informed Consent for Use of Remaining Samples in Exploratory Research
Elements specified in this section
| Element | IRI | Conformance | TS block |
|---|---|---|---|
| Description of Informed Consent Process | C217352.C184390 | Required | 512 |
| Description of Assent Process | C217352.C218815 | Optional | 513 |
| Description of Emergency Consent Process | C217352.C218816 | Optional | 514 |
In the ICH M11 Template
- Heading
- Informed Consent Process
- Page
- p. 60
| Field | Template | Page | Realises | Linked by |
|---|---|---|---|---|
<Enter Description of Informed Consent Process> | p. 60 | Description of Informed Consent Process | ts-term / verb-dropped / section | |
<Enter Description of Assent Process> | optional | p. 60 | Description of Assent Process | ts-term / verb-dropped / section |
<Enter Description of Emergency Consent Process> | optional | p. 60 | Description of Emergency Consent Process | 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.