6 TRIAL INTERVENTION AND CONCOMITANT THERAPY
https://w3id.org/m11-rdf/C217272.C218560
- Definition
- Section 6 of the ICH M11 Protocol standard, TRIAL INTERVENTION AND CONCOMITANT THERAPY.
- Section number
- 6
- Broader
- top level
- Namespace
- ICH M11 Section 6 Terminology
- NCIt concept
- http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C218560 (EVS identifier)
NCIT_C218560 (OBO PURL) - EVS term
- http://rdf.ich.org/ich-terminology#C217272.C218560 (EVS term IRI; does not resolve)
Subsections
- 6.1 Description of Investigational Trial Intervention
- 6.2 Rationale for Investigational Trial Intervention Dose and Regimen
- 6.3 Investigational Trial Intervention Administration
- 6.4 Investigational Trial Intervention Dose Modification
- 6.5 Management of Investigational Trial Intervention Overdose
- 6.6 Preparation, Storage, Handling and Accountability of Investigational Trial Intervention
- 6.7 Investigational Trial Intervention Assignment, Randomisation and Blinding
- 6.8 Investigational Trial Intervention Adherence
- 6.9 Description of Noninvestigational Trial Intervention
- 6.10 Concomitant Therapy
Elements specified in this section
| Element | IRI | Conformance | TS block |
|---|---|---|---|
| description of the overview of trial interventions or a heading for the optional table | C217347.C218747 | Required | 290 |
| Arm Name | C217347.C93729 | Optional: if the table used | 303 |
| Arm Type | C217347.C172457 | Optional: if the table used | 304 |
| Intervention Name | C217347.C177930 | Optional: if the table used | 305 |
| Intervention Type | C217347.C98747 | Optional: if the table used | 306 |
| Pharmaceutical Dose Form | C217347.C42636 | Optional: if the table used | 307 |
| Dosage Strength(s) | C217347.C142517 | Optional: if the table used | 308 |
| Dosage Level(s) | C217347.C94394 | Optional: if the table used | 309 |
| Route of Administration | C217347.C38114 | Optional: if the table used | 310 |
| Regimen/Treatment Period/Vaccination Regimen | C217347.C15697 | Optional: if the table used | 311 |
| Use | C217347.C218748 | Optional: if the table used | 312 |
| IMP or NIMP | C217347.C218749 | Optional: if the table used | 313 |
| Sourcing | C217347.C218750 | Optional: if the table used | 314 |
In the ICH M11 Template
- Heading
- TRIAL INTERVENTION AND CONCOMITANT THERAPY
- Page
- p. 35
| Field | Template | Page | Realises | Linked by |
|---|---|---|---|---|
<Enter description of the overview of trial interventions or a heading for the optional table> | p. 36 | description of the overview of trial interventions or a heading for the optional table | ts-term / verb-dropped / section | |
<Enter Arm Name> | optional | p. 37 | Arm Name | ts-term / verb-dropped / section |
[Select Arm Type] | optional | p. 37 | Arm Type | ts-term / verb-dropped / section |
<Enter Intervention Name> | optional | p. 37 | Intervention Name | ts-term / verb-dropped / section |
[Select Intervention Type] | optional | p. 37 | Intervention Type | ts-term / verb-dropped / section |
[Select Pharmaceutical Dose Form] | optional | p. 37 | Pharmaceutical Dose Form | ts-term / verb-dropped / section |
<Enter Dosage Strength(s)> | optional | p. 37 | Dosage Strength(s) | ts-term / verb-dropped / section |
<Enter Dosage Level(s)> | optional | p. 37 | Dosage Level(s) | ts-term / verb-dropped / section |
[Select Route of Administration] | optional | p. 37 | Route of Administration | ts-term / verb-dropped / section |
<Enter Regimen/Treatment Period/Vaccination Regimen> | optional | p. 37 | Regimen/Treatment Period/Vaccination Regimen | ts-term / verb-dropped / section |
[Select Use] | optional | p. 37 | Use | ts-term / verb-dropped / section |
[Select IMP or NIMP] | optional | p. 37 | IMP or NIMP | ts-term / verb-dropped / section |
[Select Sourcing] | optional | p. 37 | Sourcing | 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.