11.9 Source Records
https://w3id.org/m11-rdf/C217272.C218662
- Definition
- Section 11.9 of the ICH M11 Protocol standard, Source Records.
- Section number
- 11.9
- Broader
- 11 TRIAL OVERSIGHT AND OTHER GENERAL CONSIDERATIONS
- NCIt concept
- http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C218662 (EVS identifier)
NCIT_C218662 (OBO PURL) - EVS term
- http://rdf.ich.org/ich-terminology#C217272.C218662 (EVS term IRI; does not resolve)
Elements specified in this section
| Element | IRI | Conformance | TS block |
|---|---|---|---|
| Source Records Introduction | C217352.C218824 | Required | 530 |
| Investigator Expectations for Source Records | C217352.C218825 | Required | 531 |
| Trial Monitor Expectations for Source Records | C217352.C218826 | Required | 532 |
| Identification of Source Records | C217352.C222675 | Required | 533 |
In the ICH M11 Template
- Heading
- Source Records
- Page
- p. 62
| Field | Template | Page | Realises | Linked by |
|---|---|---|---|---|
<Enter Source Records Introduction> | p. 62 | Source Records Introduction | ts-term / verb-dropped / section | |
<Enter Investigator Expectations for Source Records> | p. 62 | Investigator Expectations for Source Records | ts-term / verb-dropped / section | |
<Enter Trial Monitor Expectations for Source Records> | p. 62 | Trial Monitor Expectations for Source Records | ts-term / verb-dropped / section | |
<Enter Identification of Source Records> | p. 62 | Identification of Source Records | 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.