1.1.2 Overall Design
https://w3id.org/m11-rdf/C217272.C218517
- Definition
- Section 1.1.2 of the ICH M11 Protocol standard, Overall Design.
- Section number
- 1.1.2
- Broader
- 1.1 Protocol Synopsis
- NCIt concept
- http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C218517 (EVS identifier)
NCIT_C218517 (OBO PURL) - EVS term
- http://rdf.ich.org/ich-terminology#C217272.C218517 (EVS term IRI; does not resolve)
Elements specified in this section
| Element | IRI | Conformance | TS block |
|---|---|---|---|
| Sponsor’s Investigational Product Code(s) | C217342.C218675 | Required Either Sponsor Investigational Product Code or Nonproprietary Name | 96 |
| Nonproprietary Name(s) | C217342.C97054 | Required Either Sponsor Investigational Product Code or Nonproprietary Name | 97 |
| Intervention Model | C217342.C98746 | Required | 99 |
| Population Type | C217342.C218703 | Required | 101 |
| Control Type | C217342.C49647 | Required | 103 |
| Population Diagnosis or Condition | C217342.C112038 | Required | 105 |
| Nonproprietary Name(s) | C217342.C97054 | Conditional: if there is a Nonproprietary Name | 108 |
| INN | C217342.C142585 | Conditional: if there is an INN | 109 |
| Minimum Age | C217342.C49693 | Required | 113 |
| Units of Age | C217342.C50400 | Required | 114 |
| Maximum Age | C217342.C49694 | Required | 116 |
| Units of Age | C217342.C50400 | Required | 117 |
| Intervention Assignment Method | C217342.C218475 | Required | 119 |
| Randomisation Type | C217342.C223137 | Conditional if Randomisation is selected as Valid Value | 120 |
| Stratification Indicator | C217342.C223136 | Required | 123 |
| Site Distribution | C217342.C218704 | Required | 125 |
| Site Geographic Scope | C217342.C218705 | Required | 126 |
| Master Protocol Indicator | C217342.C218707 | Required | 128 |
| Drug/Device Combination Product Indicator | C217342.C218708 | Required | 130 |
| Adaptive Trial Design Indicator | C217342.C218706 | Required | 132 |
| Number of Arms | C217342.C98771 | Required | 134 |
| Trial Blind Schema | C217342.C49658 | Required | 136 |
| Blinded Roles | C217342.C218709 | Required | 138 |
| Target/Maximum | C217342.C218710 | Required | 140 |
| Number of Participants | C217342.C49692 | Required | 141 |
| randomly assigned to trial intervention/enrolled | C217342.C218711 | Required | 142 |
| total planned duration of trial intervention | C217342.C218712 | Conditional: when Planned Duration of trial Intervention Number and unit of time | 145 |
| total planned duration of trial intervention unit of time | C217342.C218713 | Conditional: when Planned Duration of trial Intervention Number and unit of time | 145 |
| Alternate Description of Planned Duration of Trial Intervention | C217342.C218714 | Conditional: when an alternate description for planned duration of trial Intervention if the duration varies | 146 |
| total planned duration of trial participation | C217342.C218715 | Conditional: when planned duration of trial participation number and unit of time | 148 |
| total planned duration of trial participation unit of time | C217342.C218716 | Conditional: when planned duration of trial participation number and unit of time | 148 |
| Alternate Description of Planned Duration of Trial Participation | C217342.C218717 | Conditional: when an alternate description for planned duration of trial participation if duration will vary | 149 |
| Additional Description of Duration | C217342.C218838 | Optional | 150 |
| Independent Committees | C217342.C218718 | Required | 153 |
| Other Committees | C217342.C218719 | Optional | 155 |
In the ICH M11 Template
- Heading
- Overall Design
- Page
- p. 22
| Field | Template | Page | Realises | Linked by |
|---|---|---|---|---|
<Enter Sponsor’s Investigational Product Code(s)> | conditional | p. 22 | Sponsor’s Investigational Product Code(s) | ts-term / verb-dropped / section |
<Enter Nonproprietary Name(s)> | conditional | p. 22 | Nonproprietary Name(s) | ts-term / verb-dropped / section |
[Population Type] | p. 22 | Population Type | ts-term / exact / section | |
[Intervention Model] | p. 22 | Intervention Model | ts-term / exact / section | |
[Population Diagnosis or Condition] | p. 22 | Population Diagnosis or Condition | ts-term / exact / section | |
[Control Type] | p. 23 | Control Type | ts-term / exact / section | |
<Enter Minimum Age> | p. 23 | Minimum Age | ts-term / verb-dropped / section | |
[Units of Age] | p. 23 | Units of Age | ts-term / exact / section | |
<Enter Maximum Age> | p. 23 | Maximum Age | ts-term / verb-dropped / section | |
[Units of Age] | p. 23 | Units of Age | ts-term / exact / section | |
[Nonproprietary Name] | conditional | p. 23 | Nonproprietary Name(s) | ts-term / exact / section |
[INN] | conditional | p. 23 | INN | evs-label / exact / section |
<Enter “Not applicable”> | conditional | p. 23 | none | |
[Site Distribution] | p. 23 | Site Distribution | ts-term / exact / section | |
[Site Geographic Scope] | p. 23 | Site Geographic Scope | ts-term / exact / section | |
[Intervention Assignment Method] | p. 23 | Intervention Assignment Method | ts-term / exact / section | |
<Randomisation Type> | conditional | p. 23 | Randomisation Type | ts-term / exact / section |
<Other Intervention Assignment Method> | conditional | p. 23 | Other Intervention Assignment Method | ts-term / exact / namespace |
[Master Protocol Indicator] | p. 23 | Master Protocol Indicator | ts-term / exact / section | |
[Stratification Indicator] | p. 23 | Stratification Indicator | ts-term / exact / section | |
[Drug/Device Combination Product Indicator] | p. 23 | Drug/Device Combination Product Indicator | ts-term / exact / section | |
[Adaptive Trial Design Indicator] | p. 23 | Adaptive Trial Design Indicator | ts-term / exact / section | |
[Number of Arms] | p. 24 | Number of Arms | ts-term / exact / section | |
[Trial Blind Schema] | p. 24 | Trial Blind Schema | ts-term / exact / section | |
[Blinded Roles] | p. 24 | Blinded Roles | ts-term / exact / section | |
[Target/Maximum] | p. 24 | Target/Maximum | ts-term / exact / section | |
<Enter Number of Participants> | p. 24 | Number of Participants | ts-term / verb-dropped / section | |
[randomly assigned to trial intervention/enrolled] | p. 24 | randomly assigned to trial intervention/enrolled | ts-term / exact / section | |
<Enter total planned duration of trial intervention> | conditional | p. 24 | total planned duration of trial intervention | evs-label / verb-dropped / section |
[total planned duration of trial intervention unit of time] | conditional | p. 24 | total planned duration of trial intervention unit of time | evs-label / exact / section |
<Enter alternate description of planned duration of trial intervention> | conditional | p. 24 | Alternate Description of Planned Duration of Trial Intervention | ts-term / verb-dropped / section |
<Enter total planned duration of trial participation> | conditional | p. 24 | total planned duration of trial participation | evs-label / verb-dropped / section |
[total planned duration of trial participation unit of time] | conditional | p. 24 | total planned duration of trial participation unit of time | evs-label / exact / section |
<Enter alternate description of planned duration of trial participation> | conditional | p. 25 | Alternate Description of Planned Duration of Trial Participation | ts-term / verb-dropped / section |
<Enter Additional Description of Duration> | optional | p. 25 | Additional Description of Duration | ts-term / verb-dropped / section |
<Enter Independent Committees> | p. 25 | Independent Committees | ts-term / verb-dropped / section | |
<Enter Other Committees> | optional | p. 25 | Other Committees | 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.