Title Page
https://w3id.org/m11-rdf/C217272.C222769
- Definition
- Title Page Section of the ICH M11 Protocol standard, Title Page.
- Section number
- none
- Broader
- top level
- Namespace
- ICH M11 Section Title Page Terminology
- NCIt concept
- http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C222769 (EVS identifier)
NCIT_C222769 (OBO PURL) - EVS term
- http://rdf.ich.org/ich-terminology#C217272.C222769 (EVS term IRI; does not resolve)
Elements specified in this section
| Element | IRI | Conformance | TS block |
|---|---|---|---|
| Sponsor Confidentiality Statement | C217356.C181236 | Optional | 2 |
| Full Title | C217356.C132346 | Required | 4 |
| Trial Acronym | C217356.C94108 | Optional | 6 |
| Sponsor Protocol Identifier | C217356.C132351 | Required | 8 |
| Original Protocol Indicator | C217356.C218672 | Required | 10 |
| Version Number | C217356.C181232 | Optional | 12 |
| Version Date | C217356.C93813 | Optional | 14 |
| Amendment Identifier | C217356.C218477 | Conditional: when there is an amendment | 16 |
| Amendment Scope | C217356.C218673 | Conditional: when there is an amendment | 18 |
| Country Identifier | C217356.C20108 | Conditional: when Amendment scope is not global | 19 |
| Region Identifier | C217356.C218674 | Conditional: when Amendment scope is not global | 19 |
| Site Identifier | C217356.C83081 | Conditional: when Amendment scope is not global | 19 |
| Sponsor's Investigational Product Code(s) | C217356.C218675 | Optional: if there is Sponsor Investigational Product Code | 21 |
| Nonproprietary Name(s) | C217356.C97054 | Optional | 23 |
| Proprietary Name(s) | C217356.C71898 | Optional; Blank | 24 |
| Trial Phase | C217356.C48281 | Required | 26 |
| Trial Short Title | C217356.C94105 | Optional | 28 |
| Sponsor Name | C217356.C222495 | Required | 30 |
| Sponsor Name | C217356.C222495 | Required | 31 |
| Co-Sponsor Name | C217356.C218678 | Optional | 33 |
| Co-Sponsor Legal Address | C217356.C218679 | Optional | 34 |
| Local Sponsor Name | C217356.C218680 | Optional | 36 |
| Local Sponsor Legal Address | C217356.C218681 | Optional | 37 |
| Device Manufacturer Name | C217356.C218682 | Optional | 39 |
| Device Manufacturer Legal Address | C217356.C218683 | Optional | 40 |
| EU CT Number | C217356.C218684 | Optional | 42 |
| FDA IND Number | C217356.C218685 | Optional | 43 |
| IDE Number | C217356.C218686 | Optional | 44 |
| jRCT Number | C217356.C218687 | Optional | 45 |
| NCT Number | C217356.C172240 | Optional | 46 |
| NMPA IND Number | C217356.C218688 | Optional | 47 |
| WHO/UTN Number | C217356.C218689 | Optional | 48 |
| Other Regulatory or Clinical Trial Identifier | C217356.C218690 | Optional | 49 |
| Approval Date | C217356.C132352 | Required | 51 |
| State location where sponsor approval information can be found | C217356.C218484 | Required | 51 |
| sponsor signatory (e.g., name, title, signature and date) | C217356.C222014 | Optional | 53 |
| state location where sponsor signatory information can be found (e.g., electronic signature) | C217356.C222064 | Optional | 53 |
| Medical Expert contact information (as designated by sponsor) | C217356.C218693 | Optional | 55 |
| state location where Medical Expert contact information can be found | C217356.C222063 | Optional | 55 |
In the ICH M11 Template
No heading of its own in the Template.
| Field | Template | Page | Realises | Linked by |
|---|---|---|---|---|
<Enter Sponsor Confidentiality Statement> | optional | p. 9 | Sponsor Confidentiality Statement | ts-term / verb-dropped / section |
<Enter Full Title> | p. 9 | Full Title | ts-term / verb-dropped / section | |
<Enter Trial Acronym> | optional | p. 9 | Trial Acronym | ts-term / verb-dropped / section |
<Enter Sponsor Protocol Identifier> | p. 9 | Sponsor Protocol Identifier | ts-term / verb-dropped / section | |
[Original Protocol Indicator] | p. 9 | Original Protocol Indicator | ts-term / exact / section | |
<Enter Version Number> | optional | p. 9 | Version Number | ts-term / verb-dropped / section |
<Enter Version Date> | optional | p. 9 | Version Date | ts-term / verb-dropped / section |
[Amendment Identifier] | conditional | p. 9 | Amendment Identifier | ts-term / exact / section |
[Amendment Scope] | conditional | p. 10 | Amendment Scope | ts-term / exact / section |
[Country Identifier] | conditional | p. 10 | Country Identifier | evs-label / exact / section |
[Region Identifier] | conditional | p. 10 | Region Identifier | evs-label / exact / section |
<Enter Site Identifier> | conditional | p. 10 | Site Identifier | evs-label / verb-dropped / section |
<Enter Sponsor’s Investigational Product Code(s)> | optional | p. 10 | Sponsor's Investigational Product Code(s) | ts-term / verb-dropped / section |
<Enter Nonproprietary Name(s)> | optional | p. 10 | Nonproprietary Name(s) | ts-term / verb-dropped / section |
<Enter Proprietary Name(s)> | optional | p. 10 | Proprietary Name(s) | ts-term / verb-dropped / section |
[Trial Phase] | p. 10 | Trial Phase | ts-term / exact / section | |
<Enter Trial Short Title> | optional | p. 10 | Trial Short Title | ts-term / verb-dropped / section |
<Enter Sponsor Name> | p. 11 | Sponsor Name | ts-term / verb-dropped / section | |
<Enter Sponsor Legal Address> | p. 11 | Sponsor Name | ts-term / verb-dropped / section | |
<Enter Co-Sponsor Name> | optional | p. 11 | Co-Sponsor Name | ts-term / verb-dropped / section |
<Enter Co-Sponsor Legal Address> | optional | p. 11 | Co-Sponsor Legal Address | ts-term / verb-dropped / section |
<Enter Local Sponsor Name> | optional | p. 11 | Local Sponsor Name | ts-term / verb-dropped / section |
<Enter Local Sponsor Legal Address> | optional | p. 11 | Local Sponsor Legal Address | ts-term / verb-dropped / section |
<Enter Device Manufacturer Name> | optional | p. 11 | Device Manufacturer Name | ts-term / verb-dropped / section |
<Enter Device Manufacturer Legal Address> | optional | p. 11 | Device Manufacturer Legal Address | ts-term / verb-dropped / section |
<EU CT Number> | optional | p. 12 | EU CT Number | ts-term / exact / section |
<FDA IND Number> | optional | p. 12 | FDA IND Number | ts-term / exact / section |
<IDE Number> | optional | p. 12 | IDE Number | ts-term / exact / section |
<jRCT Number> | optional | p. 12 | jRCT Number | ts-term / exact / section |
<NCT Number> | optional | p. 12 | NCT Number | ts-term / exact / section |
<NMPA IND Number> | optional | p. 12 | NMPA IND Number | ts-term / exact / section |
<WHO/UTN Number> | optional | p. 12 | WHO/UTN Number | ts-term / exact / section |
<Other Regulatory or Clinical Trial Identifier> | optional | p. 12 | Other Regulatory or Clinical Trial Identifier | ts-term / exact / section |
<Enter Sponsor Approval Date> | conditional | p. 12 | none | |
<State location where sponsor approval information can be found> | conditional | p. 12 | State location where sponsor approval information can be found | evs-label / exact / section |
<Enter sponsor signatory (e.g., name, title, signature and date)> | optional, conditional | p. 12 | sponsor signatory (e.g., name, title, signature and date) | evs-label / verb-dropped / section |
<State location where sponsor signatory information can be found (e.g., electronic signature)> | optional, conditional | p. 12 | state location where sponsor signatory information can be found (e.g., electronic signature) | evs-label / exact / section |
<Enter Medical Expert contact information (as designated by sponsor)> | optional, conditional | p. 12 | Medical Expert contact information (as designated by sponsor) | evs-label / verb-dropped / section |
<State location where Medical Expert contact information can be found> | optional, conditional | p. 12 | state location where Medical Expert contact information can be found | evs-label / exact / 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.