12.3 Prior Protocol Amendment(s)
https://w3id.org/m11-rdf/C217272.C218669
- Definition
- Section 12.3 of the ICH M11 Protocol standard, Prior Protocol Amendment(s).
- Section number
- 12.3
- Broader
- 12 APPENDIX: SUPPORTING DETAILS
- NCIt concept
- http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C218669 (EVS identifier)
NCIT_C218669 (OBO PURL) - EVS term
- http://rdf.ich.org/ich-terminology#C217272.C218669 (EVS term IRI; does not resolve)
Elements specified in this section
| Element | IRI | Conformance | TS block |
|---|---|---|---|
| Prior Protocol Amendment(s) | C217353.C218835 | Required | 551 |
| Amendment Identifier | C217353.C218477 | Required | 555 |
| Sponsor Approval Date | C217353.C132352 | Required | 556 |
| specify alternative location | C217353.C218836 | Conditional: when a specify alternative location is selected | 560 |
| Amendment Identifier | C217353.C218477 | Conditional: if amendment | 562 |
| Sponsor Approval Date | C217353.C132352 | Conditional: if amendment | 563 |
| Description of Change | C217353.C218483 | Conditional: if there is a previous amendment. Table optional | 565 |
| Brief Rationale for Change | C217353.C181233 | Conditional: if there is a previous amendment. Table optional | 567 |
| Section # and Name | C217353.C218479 | Conditional: if there is a previous amendment. Table optional | 569 |
In the ICH M11 Template
- Heading
- Prior Protocol Amendment(s)
- Page
- p. 64
- Heading is
- Prior Protocol Amendment(s) (TS term, section)
| Field | Template | Page | Realises | Linked by |
|---|---|---|---|---|
<Enter Amendment Identifier> | p. 65 | Amendment Identifier | ts-term / verb-dropped / section | |
<Enter Sponsor Approval Date> | p. 65 | Sponsor Approval Date | ts-term / verb-dropped / section | |
<#/%> | optional | p. 65 | none | |
<Enter Amendment Scope Enrollment Description> | optional | p. 65 | Amendment Scope Enrollment Description | ts-term / verb-dropped / namespace |
<Enter Sponsor Approval Date> | p. 65 | Sponsor Approval Date | ts-term / verb-dropped / section | |
<specify alternative location> | conditional | p. 65 | specify alternative location | ts-term / exact / section |
<enter Amendment Identifier> | conditional | p. 66 | Amendment Identifier | ts-term / verb-dropped / section |
<enter Sponsor Approval Date> | conditional | p. 66 | Sponsor Approval Date | ts-term / verb-dropped / section |
<Enter Description of Change> | optional | p. 66 | Description of Change | ts-term / verb-dropped / section |
<Enter Brief Rationale for Change> | optional | p. 66 | Brief Rationale for Change | ts-term / verb-dropped / section |
<Enter Section # and Name> | optional | p. 66 | Section # and Name | 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.