11 TRIAL OVERSIGHT AND OTHER GENERAL CONSIDERATIONS
https://w3id.org/m11-rdf/C217272.C218649
- Definition
- Section 11 of the ICH M11 Protocol standard, TRIAL OVERSIGHT AND OTHER GENERAL CONSIDERATIONS.
- Section number
- 11
- Broader
- top level
- Namespace
- ICH M11 Section 11 Terminology
- NCIt concept
- http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C218649 (EVS identifier)
NCIT_C218649 (OBO PURL) - EVS term
- http://rdf.ich.org/ich-terminology#C217272.C218649 (EVS term IRI; does not resolve)
Subsections
- 11.1 Regulatory and Ethical Considerations
- 11.2 Trial Oversight
- 11.3 Informed Consent Process
- 11.4 Committees
- 11.5 Insurance and Indemnity
- 11.6 Risk-Based Quality Management
- 11.7 Data Governance
- 11.8 Data Protection
- 11.9 Source Records
- 11.10 Protocol Deviations
- 11.11 Early Site Closure
- 11.12 Data Dissemination
Elements specified in this section
None.
In the ICH M11 Template
- Heading
- TRIAL OVERSIGHT AND OTHER GENERAL CONSIDERATIONS
- Page
- p. 59
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.